Generic Sunosi Availability
Last updated on Sep 11, 2024.
Sunosi is a brand name of solriamfetol, approved by the FDA in the following formulation(s):
SUNOSI (solriamfetol hydrochloride - tablet;oral)
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Manufacturer: AXSOME MALTA
Approval date: June 17, 2019
Strength(s): EQ 75MG BASE [RLD], EQ 150MG BASE [RLD]
Has a generic version of Sunosi been approved?
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.
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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 LimitedThe 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✓
- September 5, 2037
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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✓
- June 7, 2026
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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 LimitedThe 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✓
- September 5, 2037
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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 LimitedThe 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✓
- June 1, 2038
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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 LimitedThe 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✓
- March 19, 2040
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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 LimitedThe 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✓
- June 1, 2038
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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 LimitedThe 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✓
- March 19, 2040
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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✓
- September 5, 2037
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Patent 11,560,354
Patent expiration dates:
- March 6, 2039✓✓
- March 6, 2039
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Patent 11,648,232
Patent expiration dates:
- June 1, 2038✓
- June 1, 2038
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Patent 11,753,368
Patent expiration dates:
- June 7, 2026✓
- June 7, 2026
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Patent 11,771,666
Patent expiration dates:
- December 30, 2042✓
- December 30, 2042
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Patent 11,771,667
Patent expiration dates:
- December 30, 2042✓
- December 30, 2042
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Patent 11,779,554
Patent expiration dates:
- December 30, 2042✓
- December 30, 2042
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Patent 11,793,776
Patent expiration dates:
- December 30, 2042✓
- December 30, 2042
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Patent 11,839,598
Patent expiration dates:
- March 19, 2040✓
- March 19, 2040
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Patent 11,839,599
Patent expiration dates:
- March 19, 2040✓
- March 19, 2040
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Patent 11,850,226
Patent expiration dates:
- March 19, 2040✓
- March 19, 2040
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Patent 11,850,227
Patent expiration dates:
- March 19, 2040✓
- March 19, 2040
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Patent 11,850,228
Patent expiration dates:
- March 19, 2040✓
- March 19, 2040
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Patent 11,857,528
Patent expiration dates:
- March 19, 2040✓
- March 19, 2040
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Patent 11,865,098
Patent expiration dates:
- June 1, 2038✓
- June 1, 2038
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Patent 11,872,203
Patent expiration dates:
- December 30, 2042✓
- December 30, 2042
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Patent 11,872,204
Patent expiration dates:
- December 30, 2042✓
- December 30, 2042
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Patent 11,969,404
Patent expiration dates:
- March 19, 2040✓
- March 19, 2040
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Patent 11,986,454
Patent expiration dates:
- March 19, 2040✓
- March 19, 2040
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Patent 11,986,455
Patent expiration dates:
- March 19, 2040✓
- March 19, 2040
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Patent 11,998,639
Patent expiration dates:
- September 5, 2037✓✓
- September 5, 2037
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Patent 12,005,036
Patent expiration dates:
- December 30, 2042✓
- December 30, 2042
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Patent 12,036,194
Patent expiration dates:
- December 30, 2042✓
- December 30, 2042
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Patent 12,064,411
Patent expiration dates:
- December 30, 2042✓
- December 30, 2042
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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✓
- June 11, 2031
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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✓
- June 7, 2026
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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✓
- June 7, 2026
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, 2024 - NEW CHEMICAL ENTITY
- June 17, 2026 - INDICATED TO IMPROVE WAKEFULNESS IN ADULT PATIENTS WITH EXCESSIVE DAYTIME SLEEPINESS ASSOCIATED WITH NARCOLEPSY
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Glossary
Term | Definition |
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Drug Patent | A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation. |
Drug Exclusivity | Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant. |
RLD | A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.