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Generic Saphris Availability

Medically reviewed by Drugs.com. Last updated on May 11, 2021.

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

SAPHRIS (asenapine maleate - tablet;sublingual)

  • Manufacturer: ALLERGAN
    Approval date: August 13, 2009
    Strength(s): EQ 5MG BASE [RLD] [AB], EQ 10MG BASE [RLD] [AB]
  • Manufacturer: ALLERGAN
    Approval date: March 12, 2015
    Strength(s): EQ 2.5MG BASE [RLD] [AB]

Has a generic version of Saphris been approved?

A generic version of Saphris has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Saphris and have been approved by the FDA:

asenapine maleate tablet;sublingual

  • Manufacturer: ALEMBIC PHARMS LTD
    Approval date: December 10, 2020
    Strength(s): EQ 5MG BASE [AB], EQ 10MG BASE [AB]
  • Manufacturer: BRECKENRIDGE
    Approval date: December 10, 2020
    Strength(s): EQ 2.5MG BASE [AB], EQ 10MG BASE [AB]
  • Manufacturer: BRECKENRIDGE
    Approval date: March 8, 2021
    Strength(s): EQ 5MG BASE [AB]
  • Manufacturer: SIGMAPHARM LABS LLC
    Approval date: December 10, 2020
    Strength(s): EQ 5MG BASE [AB], EQ 10MG BASE [AB]

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 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.

  • 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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    • April 6, 2026
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      Patent use: METHOD OF TREATING MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR DISORDER IN PEDIATRIC PATIENTS
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    • 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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    • April 6, 2026
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      Patent use: TREATMENT OF BIPOLAR DISORDER AND SCHIZOPHRENIA
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    • 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 (AGES 10 TO ADULT)
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    • 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: MAINTENANCE MONOTHERAPY IN ADULTS
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    • 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: AS ADJUNCTIVE TREATMENT TO LITHIUM OR VALPROATE IN ADULTS
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    • 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
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • October 6, 2026
      ✓ 
      Pediatric exclusivity

Glossary

Term Definition
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.
AB Products meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (e.g. identical active ingredients, dosage form, and routes of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (e.g. AB1, AB2, AB7). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.