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Generic Saphris Availability

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

SAPHRIS (asenapine maleate - tablet;sublingual)

  • Manufacturer: FOREST LABS LLC
    Approval date: August 13, 2009
    Strength(s): [RLD], [RLD]
  • Manufacturer: FOREST LABS LLC
    Approval date: March 12, 2015
    Strength(s): [RLD]

Has a generic version of Saphris been approved?

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

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Saphris. 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 FAQs.

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.

  • Sublingual or buccal pharmaceutical composition
    Patent 5,763,476
    Issued: June 9, 1998
    Inventor(s): Delbressine; Leonardus Petrus Carla & Wieringa; Johannes Hubertus
    Assignee(s): Akzo Noble N.V.
    The invention relates to a sublingual or buccal pharmaceutical composition comprising trans-5-chloro-2-methyl-2,3,3a,12b-tetrahydro-1H-dibenz?2,3:6,7!oxepino-?4 ,5-c!pyrrole or a pharmaceutically acceptable salt thereof, and pharmaceutically acceptable auxiliaries suitable for use in sublingual or buccal compositions, and the use thereof for the manufacture of a sublingual or buccal pharmaceutical composition for the treatment of mental disorders, such as psychosis and schizophrenia.
    Patent expiration dates:
    • June 9, 2020
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      Patent use: USE OF THE ATYPICAL ANTIPSYCHOTIC ASENAPINE FOR TREATMENT OF MANIC OR MIXED EPISODES OF BIPOLAR I DISORDER: ACUTE MONOTHERAPY OF MANIC OR MIXED EPISODES IN PEDIATRIC PATIENTS AGE 10-17
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      Drug product
    • June 9, 2020
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      Patent use: METHOD OF TREATING MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR DISORDER IN PEDIATRIC PATIENTS
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      Drug product
    • June 9, 2020
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      Patent use: USE OF THE ATYPICAL ANTIPSYCHOTIC ASENAPINE FOR TREATMENT OF MANIC OR MIXED EPISODES OF BIPOLAR I DISORDER: MAINTENANCE MONOTHERAPY IN ADULTS
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      Drug product
    • June 9, 2020
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      Patent use: USE OF THE ATYPICAL ANTIPSYCHOTIC ASENAPINE FOR TREATMENT OF SCHIZOPHRENIA IN ADULTS
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      Drug product
    • June 9, 2020
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      Patent use: USE OF THE ATYPICAL ANTIPSYCHOTIC ASENAPINE FOR TREATMENT OF MANIC OR MIXED EPISODES OF BIPOLAR I DISORDER: AS ADJUNCTIVE TREATMENT TO LITHIUM OR VALPROATE IN ADULTS
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      Drug product
    • June 9, 2020
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      Patent use: METHOD OF TREATING SCHIZOPHRENIA AND BIPOLAR DISORDER
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      Drug product
    • June 9, 2020
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      Patent use: USE OF THE ATYPICAL ANTIPSYCHOTIC ASENAPINE FOR TREATMENT OF MANIC OR MIXED EPISODES OF BIPOLAR I DISORDER: ACUTE MONOTHERAPY OF MANIC OR MIXED EPISODES (AGES 10 TO ADULT)
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      Drug product
    • December 9, 2020
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      Pediatric exclusivity
  • Crystal form of asenapine maleate
    Patent 7,741,358
    Issued: June 22, 2010
    Inventor(s): Heeres; Gerhardus Johannes
    Assignee(s): N.V. Organon
    The invention relates to an orthorhombic crystal form of compound trans-5-chloro-2,3,3a,12b-tetrahydro-2-methyl-1H-dibenz [2,3:6,7]oxepino[4,5-c]pyrrole (Z)-2-butenedioate, to methods for the preparation of this crystal form and to pharmaceutical compositions comprising an orthorhombic crystal form.
    Patent expiration dates:
    • April 6, 2026
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      Patent use: USE OF THE ATYPICAL ANTIPSYCHOTIC ASENAPINE FOR TREATMENT OF MANIC OR MIXED EPISODES OF BIPOLAR I DISORDER: ACUTE MONOTHERAPY OF MANIC OR MIXED EPISODES IN PEDIATRIC PATIENTS AGE 10-17
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      Drug substance
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      Drug product
    • April 6, 2026
      ✓ 
      Patent use: METHOD OF TREATING MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR DISORDER IN PEDIATRIC PATIENTS
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • April 6, 2026
      ✓ 
      Patent use: USE OF THE ATYPICAL ANTIPSYCHOTIC ASENAPINE FOR TREATMENT OF MANIC OR MIXED EPISODES OF BIPOLAR I DISORDER: AS ADJUNCTIVE TREATMENT TO LITHIUM OR VALPROATE IN ADULTS
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • April 6, 2026
      ✓ 
      Patent use: USE OF THE ATYPICAL ANTIPSYCHOTIC ASENAPINE FOR TREATMENT OF MANIC OR MIXED EPISODES OF BIPOLAR I DISORDER: ACUTE MONOTHERAPY OF MANIC OR MIXED EPISODES (AGES 10 TO ADULT)
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • April 6, 2026
      ✓ 
      Patent use: USE OF THE ATYPICAL ANTIPSYCHOTIC ASENAPINE FOR TREATMENT OF MANIC OR MIXED EPISODES OF BIPOLAR I DISORDER: MAINTENANCE MONOTHERAPY IN ADULTS
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      Drug substance
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      Drug product
    • April 6, 2026
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      Patent use: TREATMENT OF BIPOLAR DISORDER AND SCHIZOPHRENIA
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      Drug substance
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      Drug product
    • April 6, 2026
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      Patent use: USE OF THE ATYPICAL ANTIPSYCHOTIC ASENAPINE FOR TREATMENT OF SCHIZOPHRENIA IN ADULTS
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      Drug substance
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      Drug product
    • October 6, 2026
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      Pediatric exclusivity
  • Crystal form of asenapine maleate
    Patent 8,022,228
    Issued: September 20, 2011
    Inventor(s): Heeres; Gerhardus Johannes
    Assignee(s): N.V. Organon
    The invention relates to an orthorhombic crystal form of compound trans-5-chloro-2,3,3a,12b-tetrahydro-2-methyl-1H-dibenz[2,3:6,7]oxepino[4,5-c]pyrrole(Z)-2-butenedioate, to methods for the preparation of this crystal form and to pharmaceutical compositions comprising an orthorhombic crystal form.
    Patent expiration dates:
    • April 6, 2026
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      Drug substance
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      Drug product
    • October 6, 2026
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      Pediatric exclusivity

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:
    • March 17, 2018 - NEW PATIENT POPULATION
    • March 17, 2018 - UPDATES TO THE LABELING TO REFLECT SAFETY RESULTS FROM CLINICAL TRIALS IN SCHIZOPHRENIA ADOLESCENT PATIENTS AGED 12 TO 17 YEARS
    • September 17, 2018 - PEDIATRIC EXCLUSIVITY
    • January 13, 2020 - BROADEN INITIAL STARTING DOSE FOR BIPOLAR I DISORDER TO 5-10MG TWICE DAILY
    • January 13, 2020 - MONOTHERAPY FOR THE MAINTENANCE TREATMENT OF BIPOLAR I DISORDER
Glossary
TermDefinition
Drug PatentA 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 ExclusivityExclusivity 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.
RLDA 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.
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