Saphris

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

SAPHRIS (asenapine maleate - tablet; sublingual)

• 
  Manufacturer: ORGANON USA INC
  
  Approval date: August 13, 2009
  
  Strength(s): EQ 10MG BASE ^[RLD], EQ 5MG BASE
  

Has a generic version of Saphris been approved?

No. There is currently no therapeutically equivalent version of Saphris available.

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: About generic drugs.

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, 2015
    
    ✓ 
    Patent use: METHOD OF TREATING SCHIZOPHRENIA AND BIPOLAR DISORDER
    ✓ 
    Drug product
  
  



• 
  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
    
    ✓ 
    Patent use: TREATMENT OF BIPOLAR DISORDER AND SCHIZOPHRENIA
    ✓ 
    Drug substance
    ✓ 
    Drug product
  
  

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:
  • September 3, 2013 - ADJUNCTIVE THERAPY WITH EITHER LITHIUM OR VALPROATE FOR THE ACUTE TREATMENT OF MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER
  
  
  • September 3, 2013 - MAINTENANCE TREATMENT OF SCHIZOPHRENIA IN ADULTS
  
  
  • August 13, 2014 - NEW CHEMICAL ENTITY
  
  

See also...

• Saphris Consumer Information (Drugs.com)
• Saphris Consumer Information (Wolters Kluwer)
• Saphris Consumer Information (Cerner Multum)
• Saphris Advanced Consumer Information (Micromedex)
• Saphris AHFS DI Monographs (ASHP)
• Asenapine Consumer Information (Wolters Kluwer)
• Asenapine Consumer Information (Cerner Multum)
• Asenapine Sublingual Advanced Consumer Information (Micromedex)
• Asenapine Maleate AHFS DI Monographs (ASHP)