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Last Updated: May 22, 2024

SAPHRIS Drug Patent Profile


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Which patents cover Saphris, and when can generic versions of Saphris launch?

Saphris is a drug marketed by Allergan and is included in one NDA. There are two patents protecting this drug and two Paragraph IV challenges.

The generic ingredient in SAPHRIS is asenapine maleate. There are twelve drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the asenapine maleate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Saphris

A generic version of SAPHRIS was approved as asenapine maleate by ALEMBIC on December 10th, 2020.

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Drug patent expirations by year for SAPHRIS
Drug Prices for SAPHRIS

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Recent Clinical Trials for SAPHRIS

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Amneal Pharmaceuticals, LLCPhase 2/Phase 3
Accutest Research Laboratories (I) Pvt. Ltd.Phase 2/Phase 3
University of CincinnatiPhase 2

See all SAPHRIS clinical trials

Pharmacology for SAPHRIS
Paragraph IV (Patent) Challenges for SAPHRIS
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
SAPHRIS Sublingual Tablets asenapine maleate 2.5 mg 022117 1 2017-07-27
SAPHRIS Sublingual Tablets asenapine maleate 5 mg and 10 mg 022117 4 2013-08-13

US Patents and Regulatory Information for SAPHRIS

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Allergan SAPHRIS asenapine maleate TABLET;SUBLINGUAL 022117-003 Mar 12, 2015 AB RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Allergan SAPHRIS asenapine maleate TABLET;SUBLINGUAL 022117-001 Aug 13, 2009 AB RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Allergan SAPHRIS asenapine maleate TABLET;SUBLINGUAL 022117-003 Mar 12, 2015 AB RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Allergan SAPHRIS asenapine maleate TABLET;SUBLINGUAL 022117-001 Aug 13, 2009 AB RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for SAPHRIS

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Allergan SAPHRIS asenapine maleate TABLET;SUBLINGUAL 022117-001 Aug 13, 2009 ⤷  Sign Up ⤷  Sign Up
Allergan SAPHRIS asenapine maleate TABLET;SUBLINGUAL 022117-003 Mar 12, 2015 ⤷  Sign Up ⤷  Sign Up
Allergan SAPHRIS asenapine maleate TABLET;SUBLINGUAL 022117-002 Aug 13, 2009 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for SAPHRIS

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0746317 SPC032/2010 Ireland ⤷  Sign Up SPC032/2010: 20101210, EXPIRES: 20200228
0746317 SPC/GB10/046 United Kingdom ⤷  Sign Up PRODUCT NAME: ASENAPINE; REGISTERED: UK EU/1/10/640/001 20100901; UK EU/1/10/640/002 20100901; UK EU/1/10/640/003 20100901; UK EU/1/10/640/004 20100901; UK EU/1/10/640/005 20100901; UK EU/1/10/640/006 20100901
0746317 91751 Luxembourg ⤷  Sign Up 91751, EXPIRES: 20200301
0746317 SZ 39/2010 Austria ⤷  Sign Up
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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