Generic Sunosi Availability

Last updated on May 7, 2025.

Sunosi is a brand name of solriamfetol, approved by the FDA in the following formulation(s):

SUNOSI (solriamfetol hydrochloride - tablet;oral)

• Manufacturer: AXSOME MALTA
  Approval date: June 17, 2019
  Strength(s): EQ 75MG BASE ^[RLD], EQ 150MG BASE ^[RLD]

Is there a generic version of Sunosi available?

No. There is currently no therapeutically equivalent version of Sunosi available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Sunosi. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: Generic Drug FAQ.

Related patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

• Formulations of (R)-2-amino-3-phenylpropyl carbamate
  Patent 10,195,151
  Issued: February 5, 2019
  Inventor(s): Allphin Clark Patrick & Walsh Edwin Gerard
  Assignee(s): Jazz Pharmaceuticals International III Limited
  

  The present invention relates to immediate release formulations of (R)-2-amino-3-phenylpropyl carbamate and methods of using the same to treat disorders.

  Patent expiration dates:

  • September 5, 2037
    
    ✓ 
    Drug product
• Treatment of sleep-wake disorders
  Patent 10,351,517
  Issued: July 16, 2019
  Inventor(s): Ahnaou Abdallah & Drinkenburg Wilhelmus H. I. M. & Palumbo Joseph & Sporn Jonathan
  Assignee(s): SK Biopharmaceuticals Co., Ltd.
  

  This invention is directed to a method of treating Excessive daytime Sleepiness (EDS) in a subject, comprising the step of administering a therapeutically effective amount of a compound of Formula (I): Formula (I) or a pharmaceutically acceptable salt or ester thereof wherein Rx is a member selected from the group consisting of hydrogen, lower alkyl of 1 to 8 carbon atoms, halogen selected from F, Cl, Br and I, alkoxy containing 1 to 3 carbon atoms, nitro, hydroxy, trifluoromethyl, and thioalkoxy containing 1 to 3 carbon atoms; x is an integer of 1 to 3, with the proviso that R may be the same or different when x is 2 or 3; R1 and R2 can be the same or different from each other and are independently selected from the group consisting of hydrogen, lower alkyl of 1 to 8 carbon atoms, aryl, arylalkyl, cycloalkyl of 3 to 7 carbon atoms; R1 and R2 can be joined to form a 5 to 7-membered heterocycle substituted with a member selected from the group consisting of hydrogen, alkyl, and aryl groups, wherein the cyclic compound can comprise 1 to 2 nitrogen atoms and 0 to 1 oxygen atom, wherein the nitrogen atoms are not directly connected with each other or with the ox en atom.

  Patent expiration dates:

  • June 7, 2026
    
    ✓ 
    Patent use: TO IMPROVE WAKEFULNESS IN ADULT PATIENTS WITH EXCESSIVE DAYTIME SLEEPINESS ASSOCIATED WITH NARCOLEPSY OR OBSTRUCTIVE SLEEP APNEA (OSA)
• Formulations of (R)-2-amino-3-phenylpropyl carbamate
  Patent 10,512,609
  Issued: December 24, 2019
  Inventor(s): Allphin Clark Patrick & Walsh Edwin Gerard
  Assignee(s): Jazz Pharmaceuticals Ireland Limited
  

  The present invention relates to immediate release formulations of (R)-2-amino-3-phenylpropyl carbamate and methods of using the same to treat disorders.

  Patent expiration dates:

  • September 5, 2037
    
    ✓ 
    Patent use: TO IMPROVE WAKEFULNESS IN ADULT PATIENTS WITH EXCESSIVE DAYTIME SLEEPINESS ASSOCIATED WITH NARCOLEPSY OR OBSTRUCTIVE SLEEP APNEA (OSA)
• Methods and compositions for treating excessive sleepiness
  Patent 10,912,754
  Issued: February 9, 2021
  Inventor(s): Carter Lawrence Patrick & Lu Yuan & Zomorodi Katayoun
  Assignee(s): Jazz Pharmaceuticals Ireland Limited
  

  The present invention relates to carbamoyl phenylalaninol compounds and methods of using the same to treat disorders. The invention further relates to the development of methods for treating excessive sleepiness in a subject, e.g., due to narcolepsy or obstructive sleep apnea, with the surprising outcome that “normal” levels of wakefulness are achieved based on standard objective and subjective sleepiness tests.

  Patent expiration dates:

  • June 1, 2038
    
    ✓ 
    Patent use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS ASSOCIATED WITH OBSTRUCTIVE SLEEP APNEA (OSA) IN AN ADULT THROUGH A DOSING REGIMEN THAT INCLUDES ORAL ADMINISTRATION OF 75 MG ONCE DAILY FOR AT LEAST 3 DAYS FOLLOWED BY 150 MG ONCE DAILY
• Methods of providing solriamfetol therapy to subjects with impaired renal function
  Patent 10,940,133
  Issued: March 9, 2021
  Inventor(s): Zomorodi Katayoun
  Assignee(s): Jazz Pharmaceuticals Ireland Limited
  

  The invention relates to methods for decreasing adverse effects associated with solriamfetol ([R]-2-amino-3-phenylpropylcarbamate) therapy in subjects with impaired renal function. In particular, the invention provides an optimized dose escalation scheme for subjects with moderate renal impairment which results in the subjects having increased tolerance to adverse effects associated with the administration of solriamfetol. The invention also provides adjusted dosing for safe therapeutic use of solriamfetol in subjects having severe renal impairment.

  Patent expiration dates:

  • March 19, 2040
    
    ✓ 
    Patent use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS ASSOCIATED WITH OBSTRUCTIVE SLEEP APNEA (OSA) IN A PATIENT WITH MODERATE RENAL IMPAIRMENT
• Methods and compositions for treating excessive sleepiness
  Patent 10,959,976
  Issued: March 30, 2021
  Inventor(s): Carter Lawrence Patrick & Lu Yuan & Zomorodi Katayoun
  Assignee(s): Jazz Pharmaceuticals Ireland Limited
  

  The present invention relates to carbamoyl phenylalaninol compounds and methods of using the same to treat disorders. The invention further relates to the development of methods for treating excessive sleepiness in a subject, e.g., due to narcolepsy or obstructive sleep apnea, with the surprising outcome that “normal” levels of wakefulness are achieved based on standard objective and subjective sleepiness tests.

  Patent expiration dates:

  • June 1, 2038
    
    ✓ 
    Patent use: TO IMPROVE WAKEFULNESS IN ADULT PATIENTS WITH EXCESSIVE DAYTIME SLEEPINESS ASSOCIATED WITH NARCOLEPSY OR OBSTRUCTIVE SLEEP APNEA (OSA) WITH A DOSING REGIMEN THAT INCLUDES A DOSE OF 75 MG ONCE DAILY FOR AT LEAST 3 DAYS FOLLOWED BY 150 MG ONCE DAILY
• Methods of providing solriamfetol therapy to subjects with impaired renal function
  Patent 11,160,779
  Issued: November 2, 2021
  Inventor(s): Zomorodi Katayoun
  Assignee(s): Jazz Pharmaceuticals Ireland Limited
  

  The invention relates to methods for decreasing adverse effects associated with solriamfetol ([R]-2-amino-3-phenylpropylcarbamate) therapy in subjects with impaired renal function. In particular, the invention provides an optimized dose escalation scheme for subjects with moderate renal impairment which results in the subjects having increased tolerance to adverse effects associated with the administration of solriamfetol. The invention also provides adjusted dosing for safe therapeutic use of solriamfetol in subjects having severe renal impairment.

  Patent expiration dates:

  • March 19, 2040
    
    ✓ 
    Patent use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS BY ADMINISTERING SOLRIAMFETOL TO A SUBJECT HAVING MILD, MODERATE, OR SEVERE RENAL IMPAIRMENT
• Formulations of (R)-2-amino-3-phenylpropyl carbamate
  Patent 11,439,597
  Issued: September 13, 2022
  Inventor(s): Allphin Clark Patrick & Walsh Edwin Gerard
  Assignee(s): Axsome Malta Ltd.
  

  The present invention relates to immediate release formulations of (R)-2-amino-3-phenylpropyl carbamate and methods of using the same to treat disorders.

  Patent expiration dates:

  • September 5, 2037
    
    ✓ 
    Drug product
• Compositions comprising (R)-2-amino-3-phenylpropyl carbamate and uses thereof
  Patent 11,560,354
  Issued: January 24, 2023
  Inventor(s): Hurley; Fionn
  Assignee(s): Axsome Malta Ltd. (Qormi, MT); SK Biopharmaceuticals Co., Ltd. (Seongnam-si, KR)
  

  The present invention relates to a newly identified solvate form of (R)-2-amino-3-phenylpropyl carbamate (APC) hydrochloride, a method of preparing APC hydrochloride, and methods of using the same to treat disorders. The invention further relates to methods of producing APC hydrochloride with increased purity.

  Patent expiration dates:

  • March 6, 2039
    
    ✓ 
    Patent use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS BY ADMINISTERING A COMPOSITION COMPRISING SOLRIAMFETOL HYDROCHLORIDE AND 2-CHLOROPROPANE, WHEREIN THE COMPOSITION COMPRISES LESS THAN ABOUT 5 PPM 2‑CHLOROPROPANE
    ✓ 
    Drug product
• Methods and compositions for treating excessive sleepiness
  Patent 11,648,232
  Issued: May 16, 2023
  Inventor(s): Carter; Lawrence Patrick et al.
  Assignee(s): Axsome Malta Ltd. (Qormi, MT)
  

  The present invention relates to carbamoyl phenylalaninol compounds and methods of using the same to treat disorders. The invention further relates to the development of methods for treating excessive sleepiness in a subject, e.g., due to narcolepsy or obstructive sleep apnea, with the surprising outcome that “normal” levels of wakefulness are achieved based on standard objective and subjective sleepiness tests.

  Patent expiration dates:

  • June 1, 2038
    
    ✓ 
    Patent use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS WITH A DOSING REGIMEN THAT INCLUDES ORAL ADMINISTRATION OF 75 MG ONCE DAILY FOR AT LEAST 3 DAYS FOLLOWED BY 150 MG ONCE DAILY
• Treatment of sleep-wake disorders
  Patent 11,753,368
  Issued: September 12, 2023
  Inventor(s): Ahnaou; Abdallah et al.
  Assignee(s): SK Biopharmaceuticals Co., Ltd. (Seongnam-si, KR)
  

  This invention is directed to a method of treating Excessive daytime Sleepiness (EDS) in a subject, comprising the step of administering a therapeutically effective amount of a compound of Formula (I): Formula (I) or a pharmaceutically acceptable salt or ester thereof wherein Rx is a member selected from the group consisting of hydrogen, lower alkyl of 1 to 8 carbon atoms, halogen selected from F, Cl, Br and I, alkoxy containing 1 to 3 carbon atoms, nitro, hydroxy, trifluoromethyl, and thioalkoxy containing 1 to 3 carbon atoms; x is an integer of 1 to 3, with the proviso that R may be the same or different when x is 2 or 3; R1 and R2 can be the same or different from each other and are independently selected from the group consisting of hydrogen, lower alkyl of 1 to 8 carbon atoms, aryl, arylalkyl, cycloalkyl of 3 to 7 carbon atoms; R1 and R2 can be joined to form a 5 to 7-membered heterocycle substituted with a member selected from the group consisting of hydrogen, alkyl, and aryl groups, wherein the cyclic compound can comprise 1 to 2 nitrogen atoms and 0 to 1 oxygen atom, wherein the nitrogen atoms are not directly connected with each other or with the ox en atom.

  Patent expiration dates:

  • June 7, 2026
    
    ✓ 
    Patent use: TO IMPROVE WAKEFULNESS IN ADULT PATIENTS WITH EXCESSIVE DAYTIME SLEEPINESS ASSOCIATED WITH NARCOLEPSY OR OBSTRUCTIVE SLEEP APNEA (OSA)
• Methods of administering solriamfetol to lactating women
  Patent 11,771,666
  Issued: October 3, 2023
  Inventor(s): Tabuteau; Herriot
  Assignee(s): Axsome Malta Ltd. (Qormi, MT)
  

  Provided herein according to some embodiments is a method for decreasing the potential for adverse events from solriamfetol in an infant fed breast milk obtained from a subject treated with solriamfetol comprising: orally administering the solriamfetol to the subject at a daily dose of about 37.5 mg to about 300 mg; and feeding the infant breast milk from the subject at least about 5 hours after administering the solriamfetol to the subject, thereby decreasing potential for adverse events from solriamfetol in an infant.

  Patent expiration dates:

  • December 30, 2042
    
    ✓ 
    Patent use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS IN A BREAST-FEEDING PATIENT WHILE REDUCING INFANT EXPOSURE TO SOLRIAMFETOL
• Methods of administering solriamfetol to lactating women
  Patent 11,771,667
  Issued: October 3, 2023
  Inventor(s): Tabuteau; Herriot
  Assignee(s): Axsome Malta Ltd. (Qormi, MT)
  

  Provided herein according to some embodiments is a method for decreasing the potential for adverse events from solriamfetol in an infant fed breast milk obtained from a subject treated with solriamfetol comprising: orally administering the solriamfetol to the subject at a daily dose of about 37.5 mg to about 300 mg; and feeding the infant breast milk from the subject at least about 5 hours after administering the solriamfetol to the subject, thereby decreasing potential for adverse events from solriamfetol in an infant.

  Patent expiration dates:

  • December 30, 2042
    
    ✓ 
    Patent use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS IN A BREAST-FEEDING PATIENT WHILE REDUCING INFANT EXPOSURE TO SOLRIAMFETOL
• Methods of administering solriamfetol to lactating women
  Patent 11,779,554
  Issued: October 10, 2023
  Inventor(s): Tabuteau; Herriot
  Assignee(s): Axsome Malta Ltd. (Qormi, MT)
  

  Provided herein according to some embodiments is a method for decreasing the potential for adverse events from solriamfetol in an infant fed breast milk obtained from a subject treated with solriamfetol comprising: orally administering the solriamfetol to the subject at a daily dose of about 37.5 mg to about 300 mg; and feeding the infant breast milk from the subject at least about 5 hours after administering the solriamfetol to the subject, thereby decreasing potential for adverse events from solriamfetol in an infant.

  Patent expiration dates:

  • December 30, 2042
    
    ✓ 
    Patent use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS IN A BREAST-FEEDING PATIENT WHILE REDUCING INFANT EXPOSURE TO SOLRIAMFETOL
• Methods of administering solriamfetol to lactating women
  Patent 11,793,776
  Issued: October 24, 2023
  Inventor(s): Tabuteau; Herriot
  Assignee(s): Axsome Malta Ltd. (Qormi, MT)
  

  Provided herein according to some embodiments is a method for decreasing the potential for adverse events from solriamfetol in an infant fed breast milk obtained from a subject treated with solriamfetol comprising: orally administering the solriamfetol to the subject at a daily dose of about 37.5 mg to about 300 mg; and feeding the infant breast milk from the subject at least about 5 hours after administering the solriamfetol to the subject, thereby decreasing potential for adverse events from solriamfetol in an infant.

  Patent expiration dates:

  • December 30, 2042
    
    ✓ 
    Patent use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS IN A BREAST-FEEDING PATIENT WHILE REDUCING INFANT EXPOSURE TO SOLRIAMFETOL
• Methods of providing solriamfetol therapy to subjects with impaired renal function
  Patent 11,839,598
  Issued: December 12, 2023
  Inventor(s): Zomorodi; Katayoun
  Assignee(s): Axsome Malta Ltd. (Qormi, MT)
  

  The invention relates to methods for decreasing adverse effects associated with solriamfetol ([R]-2-amino-3-phenylpropylcarbamate) therapy in subjects with impaired renal function. In particular, the invention provides an optimized dose escalation scheme for subjects with moderate renal impairment which results in the subjects having increased tolerance to adverse effects associated with the administration of solriamfetol. The invention also provides adjusted dosing for safe therapeutic use of solriamfetol in subjects having severe renal impairment.

  Patent expiration dates:

  • March 19, 2040
    
    ✓ 
    Patent use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS BY ADMINISTERING SOLRIAMFETOL TO A SUBJECT HAVING MODERATE OR SEVERE RENAL IMPAIRMENT
• Methods of providing solriamfetol therapy to subjects with impaired renal function
  Patent 11,839,599
  Issued: December 12, 2023
  Inventor(s): Zomorodi; Katayoun
  Assignee(s): Axsome Malta Ltd. (Qormi, MT)
  

  The invention relates to methods for decreasing adverse effects associated with solriamfetol ([R]-2-amino-3-phenylpropylcarbamate) therapy in subjects with impaired renal function. In particular, the invention provides an optimized dose escalation scheme for subjects with moderate renal impairment which results in the subjects having increased tolerance to adverse effects associated with the administration of solriamfetol. The invention also provides adjusted dosing for safe therapeutic use of solriamfetol in subjects having severe renal impairment.

  Patent expiration dates:

  • March 19, 2040
    
    ✓ 
    Patent use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS BY ADMINISTERING SOLRIAMFETOL TO A SUBJECT HAVING OBSTRUCTIVE SLEEP APNEA (OSA) AND NO, MILD, MODERATE, OR SEVERE RENAL IMPAIRMENT
• Methods of providing solriamfetol therapy to subjects with impaired renal function
  Patent 11,850,226
  Issued: December 26, 2023
  Inventor(s): Zomorodi; Katayoun
  Assignee(s): Axsome Malta Ltd. (Qormi, MT)
  

  The invention relates to methods for decreasing adverse effects associated with solriamfetol ([R]-2-amino-3-phenylpropylcarbamate) therapy in subjects with impaired renal function. In particular, the invention provides an optimized dose escalation scheme for subjects with moderate renal impairment which results in the subjects having increased tolerance to adverse effects associated with the administration of solriamfetol. The invention also provides adjusted dosing for safe therapeutic use of solriamfetol in subjects having severe renal impairment.

  Patent expiration dates:

  • March 19, 2040
    
    ✓ 
    Patent use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS BY ADMINISTERING SOLRIAMFETOL TO A SUBJECT HAVING NO, MILD, MODERATE, OR SEVERE RENAL IMPAIRMENT
• Methods of providing solriamfetol therapy to subjects with impaired renal function
  Patent 11,850,227
  Issued: December 26, 2023
  Inventor(s): Zomorodi; Katayoun
  Assignee(s): Axsome Malta Ltd. (Qormi, MT)
  

  The invention relates to methods for decreasing adverse effects associated with solriamfetol ([R]-2-amino-3-phenylpropylcarbamate) therapy in subjects with impaired renal function. In particular, the invention provides an optimized dose escalation scheme for subjects with moderate renal impairment which results in the subjects having increased tolerance to adverse effects associated with the administration of solriamfetol. The invention also provides adjusted dosing for safe therapeutic use of solriamfetol in subjects having severe renal impairment.

  Patent expiration dates:

  • March 19, 2040
    
    ✓ 
    Patent use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS BY ADMINISTERING SOLRIAMFETOL TO A SUBJECT HAVING NO, MILD, MODERATE, OR SEVERE RENAL IMPAIRMENT
• Methods of providing solriamfetol therapy to subjects with impaired renal function
  Patent 11,850,228
  Issued: December 26, 2023
  Inventor(s): Zomorodi; Katayoun
  Assignee(s): Axsome Malta Ltd. (Qormi, MT)
  

  The invention relates to methods for decreasing adverse effects associated with solriamfetol ([R]-2-amino-3-phenylpropylcarbamate) therapy in subjects with impaired renal function. In particular, the invention provides an optimized dose escalation scheme for subjects with moderate renal impairment which results in the subjects having increased tolerance to adverse effects associated with the administration of solriamfetol. The invention also provides adjusted dosing for safe therapeutic use of solriamfetol in subjects having severe renal impairment.

  Patent expiration dates:

  • March 19, 2040
    
    ✓ 
    Patent use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS BY ADMINISTERING SOLRIAMFETOL TO A SUBJECT HAVING NO, MILD, MODERATE, OR SEVERE RENAL IMPAIRMENT
• Methods of providing solriamfetol therapy to subjects with impaired renal function
  Patent 11,857,528
  Issued: January 2, 2024
  Inventor(s): Zomorodi; Katayoun
  Assignee(s): Axsome Malta Ltd. (Qormi, MT)
  

  The invention relates to methods for decreasing adverse effects associated with solriamfetol ([R]-2-amino-3-phenylpropylcarbamate) therapy in subjects with impaired renal function. In particular, the invention provides an optimized dose escalation scheme for subjects with moderate renal impairment which results in the subjects having increased tolerance to adverse effects associated with the administration of solriamfetol. The invention also provides adjusted dosing for safe therapeutic use of solriamfetol in subjects having severe renal impairment.

  Patent expiration dates:

  • March 19, 2040
    
    ✓ 
    Patent use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS BY ADMINISTERING SOLRIAMFETOL TO A SUBJECT HAVING MILD, MODERATE, OR SEVERE RENAL IMPAIRMENT
• Methods and compositions for treating excessive sleepiness
  Patent 11,865,098
  Issued: January 9, 2024
  Inventor(s): Carter; Lawrence Patrick et al.
  Assignee(s): Axsome Malta Ltd. (Qormi, MT)
  

  The present invention relates to carbamoyl phenylalaninol compounds and methods of using the same to treat disorders. The invention further relates to the development of methods for treating excessive sleepiness in a subject, e.g., due to narcolepsy or obstructive sleep apnea, with the surprising outcome that “normal” levels of wakefulness are achieved based on standard objective and subjective sleepiness tests.

  Patent expiration dates:

  • June 1, 2038
    
    ✓ 
    Patent use: TO IMPROVE WAKEFULNESS IN ADULT PATIENTS WITH EXCESSIVE DAYTIME SLEEPINESS ASSOCIATED WITH NARCOLEPSY OR OBSTRUCTIVE SLEEP APNEA (OSA)
• Methods of administering solriamfetol to lactating women
  Patent 11,872,203
  Issued: January 16, 2024
  Inventor(s): Tabuteau; Herriot
  Assignee(s): Axsome Malta Ltd. (Qormi, MT)
  

  Provided herein according to some embodiments is a method for decreasing the potential for adverse events from solriamfetol in an infant fed breast milk obtained from a subject treated with solriamfetol comprising: orally administering the solriamfetol to the subject at a daily dose of about 37.5 mg to about 300 mg; and feeding the infant breast milk from the subject at least about 5 hours after administering the solriamfetol to the subject, thereby decreasing potential for adverse events from solriamfetol in an infant.

  Patent expiration dates:

  • December 30, 2042
    
    ✓ 
    Patent use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS IN A BREAST-FEEDING PATIENT WHILE REDUCING INFANT EXPOSURE TO SOLRIAMFETOL
• Methods of administering solriamfetol to lactating women
  Patent 11,872,204
  Issued: January 16, 2024
  Inventor(s): Tabuteau; Herriot
  Assignee(s): Axsome Malta Ltd. (Qormi, MT)
  

  Provided herein according to some embodiments is a method for decreasing the potential for adverse events from solriamfetol in an infant fed breast milk obtained from a subject treated with solriamfetol comprising: orally administering the solriamfetol to the subject at a daily dose of about 37.5 mg to about 300 mg; and feeding the infant breast milk from the subject at least about 5 hours after administering the solriamfetol to the subject, thereby decreasing potential for adverse events from solriamfetol in an infant.

  Patent expiration dates:

  • December 30, 2042
    
    ✓ 
    Patent use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS IN A BREAST-FEEDING PATIENT WHILE REDUCING INFANT EXPOSURE TO SOLRIAMFETOL
• Methods of providing solriamfetol therapy to subjects with impaired renal function
  Patent 11,969,404
  Issued: April 30, 2024
  Inventor(s): Zomorodi; Katayoun
  Assignee(s): AXSOME MALTA LTD. (Qormi, MT)
  

  The invention relates to methods for decreasing adverse effects associated with solriamfetol ([R]-2-amino-3-phenylpropylcarbamate) therapy in subjects with impaired renal function. In particular, the invention provides an optimized dose escalation scheme for subjects with moderate renal impairment which results in the subjects having increased tolerance to adverse effects associated with the administration of solriamfetol. The invention also provides adjusted dosing for safe therapeutic use of solriamfetol in subjects having severe renal impairment.

  Patent expiration dates:

  • March 19, 2040
    
    ✓ 
    Patent use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS BY ADMINISTERING SOLRIAMFETOL TO A SUBJECT HAVING A HISTORY OF BIPOLAR DISORDERS AND MODERATE OR SEVERE RENAL IMPAIRMENT
• Methods of providing solriamfetol therapy to subjects with impaired renal function
  Patent 11,986,454
  Issued: May 21, 2024
  Inventor(s): Zomorodi; Katayoun
  Assignee(s): AXSOME MALTA LTD. (Qormi, MT)
  

  The invention relates to methods for decreasing adverse effects associated with solriamfetol ([R]-2-amino-3-phenylpropylcarbamate) therapy in subjects with impaired renal function. In particular, the invention provides an optimized dose escalation scheme for subjects with moderate renal impairment which results in the subjects having increased tolerance to adverse effects associated with the administration of solriamfetol. The invention also provides adjusted dosing for safe therapeutic use of solriamfetol in subjects having severe renal impairment.

  Patent expiration dates:

  • March 19, 2040
    
    ✓ 
    Patent use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS BY ADMINISTERING SOLRIAMFETOL TO A SUBJECT HAVING NO, MILD, MODERATE, OR SEVERE RENAL IMPAIRMENT
• Methods of providing solriamfetol therapy to subjects with impaired renal function
  Patent 11,986,455
  Issued: May 21, 2024
  Inventor(s): Zomorodi; Katayoun
  Assignee(s): AXSOME MALTA LTD. (Qormi, MT)
  

  The invention relates to methods for decreasing adverse effects associated with solriamfetol ([R]-2-amino-3-phenylpropylcarbamate) therapy in subjects with impaired renal function. In particular, the invention provides an optimized dose escalation scheme for subjects with moderate renal impairment which results in the subjects having increased tolerance to adverse effects associated with the administration of solriamfetol. The invention also provides adjusted dosing for safe therapeutic use of solriamfetol in subjects having severe renal impairment.

  Patent expiration dates:

  • March 19, 2040
    
    ✓ 
    Patent use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS BY ADMINISTERING SOLRIAMFETOL TO A SUBJECT HAVING MILD, MODERATE, OR SEVERE RENAL IMPAIRMENT
• Formulations of (R)-2-amino-3-phenylpropyl carbamate
  Patent 11,998,639
  Issued: June 4, 2024
  Inventor(s): Allphin; Clark Patrick et al.
  Assignee(s): AXSOME MALTA LTD. (Qormi, MT)
  

  The present invention relates to immediate release formulations of (R)-2-amino-3-phenylpropyl carbamate and methods of using the same to treat disorders.

  Patent expiration dates:

  • September 5, 2037
    
    ✓ 
    Patent use: TO IMPROVE WAKEFULNESS IN ADULT PATIENTS WITH EXCESSIVE DAYTIME SLEEPINESS ASSOCIATED WITH NARCOLEPSY OR OBSTRUCTIVE SLEEP APNEA (OSA)
    ✓ 
    Drug product
• Methods of administering solriamfetol to lactating women
  Patent 12,005,036
  Issued: June 11, 2024
  Inventor(s): Tabuteau; Herriot
  Assignee(s): AXSOME MALTA LTD. (Qormi, MT)
  

  Provided herein according to some embodiments is a method for decreasing the potential for adverse events from solriamfetol in an infant fed breast milk obtained from a subject treated with solriamfetol comprising: orally administering the solriamfetol to the subject at a daily dose of about 37.5 mg to about 300 mg; and feeding the infant breast milk from the subject at least about 5 hours after administering the solriamfetol to the subject, thereby decreasing potential for adverse events from solriamfetol in an infant.

  Patent expiration dates:

  • December 30, 2042
    
    ✓ 
    Patent use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS IN A BREAST-FEEDING PATIENT WHILE REDUCING INFANT EXPOSURE TO SOLRIAMFETOL
• Methods of administering solriamfetol to lactating women
  Patent 12,036,194
  Issued: July 16, 2024
  Inventor(s): Tabuteau; Herriot
  Assignee(s): AXSOME MALTA LTD. (Qormi, MT)
  

  Provided herein according to some embodiments is a method for decreasing the potential for adverse events from solriamfetol in an infant fed breast milk obtained from a subject treated with solriamfetol comprising: orally administering the solriamfetol to the subject at a daily dose of about 37.5 mg to about 300 mg; and feeding the infant breast milk from the subject at least about 5 hours after administering the solriamfetol to the subject, thereby decreasing potential for adverse events from solriamfetol in an infant.

  Patent expiration dates:

  • December 30, 2042
    
    ✓ 
    Patent use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS IN A BREAST-FEEDING PATIENT WHILE REDUCING INFANT EXPOSURE TO SOLRIAMFETOL
• Methods of administering solriamfetol to lactating women
  Patent 12,064,411
  Issued: August 20, 2024
  Inventor(s): Tabuteau; Herriot
  Assignee(s): AXSOME MALTA LTD. (Qormi, MT)
  

  Provided herein according to some embodiments is a method for decreasing the potential for adverse events from solriamfetol in an infant fed breast milk obtained from a subject treated with solriamfetol comprising: orally administering the solriamfetol to the subject at a daily dose of about 37.5 mg to about 300 mg; and feeding the infant breast milk from the subject at least about 5 hours after administering the solriamfetol to the subject, thereby decreasing potential for adverse events from solriamfetol in an infant.

  Patent expiration dates:

  • December 30, 2042
    
    ✓ 
    Patent use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS IN A BREAST-FEEDING PATIENT WHILE REDUCING INFANT EXPOSURE TO SOLRIAMFETOL
• Methods of administering solriamfetol to lactating women
  Patent 12,090,126
  Issued: September 17, 2024
  Inventor(s): Tabuteau; Herriot
  Assignee(s): AXSOME MALTA LTD. (Qormi, MT)
  

  Provided herein according to some embodiments is a method for decreasing the potential for adverse events from solriamfetol in an infant fed breast milk obtained from a subject treated with solriamfetol comprising: orally administering the solriamfetol to the subject at a daily dose of about 37.5 mg to about 300 mg; and feeding the infant breast milk from the subject at least about 5 hours after administering the solriamfetol to the subject, thereby decreasing potential for adverse events from solriamfetol in an infant.

  Patent expiration dates:

  • December 30, 2042
    
    ✓ 
    Patent use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS IN A BREAST-FEEDING PATIENT WHILE REDUCING INFANT EXPOSURE TO SOLRIAMFETOL
• Methods of administering solriamfetol to lactating women
  Patent 12,102,609
  Issued: October 1, 2024
  Inventor(s): Tabuteau; Herriot
  Assignee(s): AXSOME MALTA LTD. (Qormi CBD, MT)
  

  Provided herein according to some embodiments is a method for decreasing the potential for adverse events from solriamfetol in an infant fed breast milk obtained from a subject treated with solriamfetol comprising: orally administering the solriamfetol to the subject at a daily dose of about 37.5 mg to about 300 mg; and feeding the infant breast milk from the subject at least about 5 hours after administering the solriamfetol to the subject, thereby decreasing potential for adverse events from solriamfetol in an infant.

  Patent expiration dates:

  • December 30, 2042
    
    ✓ 
    Patent use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS IN A BREAST-FEEDING PATIENT WHILE REDUCING INFANT EXPOSURE TO SOLRIAMFETOL
• Methods of providing solriamfetol therapy to subjects with impaired renal function
  Patent 12,194,016
  Issued: January 14, 2025
  Inventor(s): Zomorodi; Katayoun
  Assignee(s): AXSOME MALTA LTD. (Qormi, MT)
  

  The invention relates to methods for decreasing adverse effects associated with solriamfetol ([R]-2-amino-3-phenylpropylcarbamate) therapy in subjects with impaired renal function. In particular, the invention provides an optimized dose escalation scheme for subjects with moderate renal impairment which results in the subjects having increased tolerance to adverse effects associated with the administration of solriamfetol. The invention also provides adjusted dosing for safe therapeutic use of solriamfetol in subjects having severe renal impairment.

  Patent expiration dates:

  • March 19, 2040
    
    ✓ 
    Patent use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS BY ADMINISTERING SOLRIAMFETOL TO A SUBJECT HAVING NO OR MILD RENAL IMPAIRMENT
• Treatment of sleep-wake disorders
  Patent 12,209,059
  Issued: January 28, 2025
  Inventor(s): Ahnaou; Abdallah et al.
  Assignee(s): SK BIOPHARMACEUTICALS CO., LTD. (Seoul, KR)
  

  This invention is directed to a method of treating Excessive daytime Sleepiness (EDS) in a subject, comprising the step of administering a therapeutically effective amount of a compound of Formula (I): Formula (I) or a pharmaceutically acceptable salt or ester thereof wherein Rx is a member selected from the group consisting of hydrogen, lower alkyl of 1 to 8 carbon atoms, halogen selected from F, Cl, Br and I, alkoxy containing 1 to 3 carbon atoms, nitro, hydroxy, trifluoromethyl, and thioalkoxy containing 1 to 3 carbon atoms; x is an integer of 1 to 3, with the proviso that R may be the same or different when x is 2 or 3; R1 and R2 can be the same or different from each other and are independently selected from the group consisting of hydrogen, lower alkyl of 1 to 8 carbon atoms, aryl, arylalkyl, cycloalkyl of 3 to 7 carbon atoms; R1 and R2 can be joined to form a 5 to 7-membered heterocycle substituted with a member selected from the group consisting of hydrogen, alkyl, and aryl groups, wherein the cyclic compound can comprise 1 to 2 nitrogen atoms and 0 to 1 oxygen atom, wherein the nitrogen atoms are not directly connected with each other or with the ox en atom.

  Patent expiration dates:

  • June 7, 2026
    
    ✓ 
    Patent use: TO IMPROVE WAKEFULNESS IN ADULT PATIENTS WITH EXCESSIVE DAYTIME SLEEPINESS ASSOCIATED WITH NARCOLEPSY OR OBSTRUCTIVE SLEEP APNEA (OSA)
• Methods of administering solriamfetol to lactating women
  Patent 12,263,145
  Issued: April 1, 2025
  Inventor(s): Tabuteau; Herriot
  Assignee(s): AXSOME MALTA LTD. (Qormi, MT)
  

  Provided herein according to some embodiments is a method for decreasing the potential for adverse events from solriamfetol in an infant fed breast milk obtained from a subject treated with solriamfetol comprising: orally administering the solriamfetol to the subject at a daily dose of about 37.5 mg to about 300 mg; and feeding the infant breast milk from the subject at least about 5 hours after administering the solriamfetol to the subject, thereby decreasing potential for adverse events from solriamfetol in an infant.

  Patent expiration dates:

  • December 30, 2042
    
    ✓ 
    Patent use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS IN A BREAST-FEEDING PATIENT WHILE REDUCING INFANT EXPOSURE TO SOLRIAMFETOL
• Treatment of sleep-wake disorders
  Patent 8,440,715
  Issued: May 14, 2013
  Inventor(s): Ahnaou Abdallah & Drinkenburg Wilhelmus H. L. M. & Palumbo Joseph & Sporn Jonathan
  Assignee(s): SK Biopharmaceuticals Co., Ltd.
  

  This invention is directed to a method of treating Excessive daytime Sleepiness (EDS) in a subject, comprising the step of administering a therapeutically effective amount of a compound of Formula (I): Formula (I) or a pharmaceutically acceptable salt or ester thereof wherein Rx is a member selected from the group consisting of hydrogen, lower alkyl of 1 to 8 carbon atoms, halogen selected from F, Cl, Br and I, alkoxy containing 1 to 3 carbon atoms, nitro, hydroxy, trifluoromethyl, and thioalkoxy containing 1 to 3 carbon atoms; x is an integer of 1 to 3, with the proviso that R may be the same or different when x is 2 or 3; Rand Rcan be the same or different from each other and are independently selected from the group consisting of hydrogen, lower alkyl of 1 to 8 carbon atoms, aryl, arylalkyl, cycloalkyl of 3 to 7 carbon atoms; Rand Rcan be joined to form a 5 to 7-membered heterocycle substituted with a member selected from the group consisting of hydrogen, alkyl, and aryl groups, wherein the cyclic compound can comprise 1 to 2 nitrogen atoms and 0 to 1 oxygen atom, wherein the nitrogen atoms are not directly connected with each other or with the ox en atom.

  Patent expiration dates:

  • June 11, 2031
    
    ✓ 
    Patent use: TO IMPROVE WAKEFULNESS IN ADULT PATIENTS WITH EXCESSIVE DAYTIME SLEEPINESS ASSOCIATED WITH NARCOLEPSY OR OBSTRUCTIVE SLEEP APNEA (OSA)
• Treatment of sleep-wake disorders
  Patent 8,877,806
  Issued: November 4, 2014
  Inventor(s): Ahnaou Abdallah & Drinkenburg Wilhelmus H. I. M. & Palumbo Joseph & Sporn Jonathan
  Assignee(s): SK Biopharmaceuticals Co., Ltd.
  

  This invention is directed to a method of treating Excessive daytime Sleepiness (EDS) in a subject, comprising the step of administering a therapeutically effective amount of a compound of Formula (I): Formula (I) or a pharmaceutically acceptable salt or ester thereof wherein Rx is a member selected from the group consisting of hydrogen, lower alkyl of 1 to 8 carbon atoms, halogen selected from F, Cl, Br and I, alkoxy containing 1 to 3 carbon atoms, nitro, hydroxy, trifluoromethyl, and thioalkoxy containing 1 to 3 carbon atoms; x is an integer of 1 to 3, with the proviso that R may be the same or different when x is 2 or 3; Rand Rcan be the same or different from each other and are independently selected from the group consisting of hydrogen, lower alkyl of 1 to 8 carbon atoms, aryl, arylalkyl, cycloalkyl of 3 to 7 carbon atoms; Rand Rcan be joined to form a 5 to 7-membered heterocycle substituted with a member selected from the group consisting of hydrogen, alkyl, and aryl groups, wherein the cyclic compound can comprise 1 to 2 nitrogen atoms and 0 to 1 oxygen atom, wherein the nitrogen atoms are not directly connected with each other or with the oxygen atom.

  Patent expiration dates:

  • June 7, 2026
    
    ✓ 
    Patent use: TO IMPROVE WAKEFULNESS IN ADULT PATIENTS WITH EXCESSIVE DAYTIME SLEEPINESS ASSOCIATED WITH NARCOLEPSY OR OBSTRUCTIVE SLEEP APNEA (OSA)
• Treatment of sleep-wake disorders
  Patent 9,604,917
  Issued: March 28, 2017
  Inventor(s): Ahnaou Abdallah & Drinkenburg Wilhelmus H. I. M. & Palumbo Joseph & Sporn Jonathan
  Assignee(s): SK Biopharmaceuticals Co., Ltd.
  

  This invention is directed to a method of treating Excessive daytime Sleepiness (EDS) in a subject, comprising the step of administering a therapeutically effective amount of a compound of Formula (I): Formula (I) or a pharmaceutically acceptable salt or ester thereof wherein Rx is a member selected from the group consisting of hydrogen, lower alkyl of 1 to 8 carbon atoms, halogen selected from F, Cl, Br and I, alkoxy containing 1 to 3 carbon atoms, nitro, hydroxy, trifluoromethyl, and thioalkoxy containing 1 to 3 carbon atoms; x is an integer of 1 to 3, with the proviso that R may be the same or different when x is 2 or 3; R1 and R2 can be the same or different from each other and are independently selected from the group consisting of hydrogen, lower alkyl of 1 to 8 carbon atoms, aryl, arylalkyl, cycloalkyl of 3 to 7 carbon atoms; R1 and R2 can be joined to form a 5 to 7-membered heterocycle substituted with a member selected from the group consisting of hydrogen, alkyl, and aryl groups, wherein the cyclic compound can comprise 1 to 2 nitrogen atoms and 0 to 1 oxygen atom, wherein the nitrogen atoms are not directly connected with each other or with the ox en atom.

  Patent expiration dates:

  • June 7, 2026
    
    ✓ 
    Patent use: TO IMPROVE WAKEFULNESS IN ADULT PATIENTS WITH EXCESSIVE DAYTIME SLEEPINESS ASSOCIATED WITH NARCOLEPSY OR OBSTRUCTIVE SLEEP APNEA (OSA)

Related exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

• Exclusivity expiration dates:

  • June 17, 2026 - INDICATED TO IMPROVE WAKEFULNESS IN ADULT PATIENTS WITH EXCESSIVE DAYTIME SLEEPINESS ASSOCIATED WITH NARCOLEPSY

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