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Last Updated: December 1, 2021

DrugPatentWatch Database Preview

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

See all SAPHRIS clinical trials

Pharmacology for SAPHRIS
Paragraph IV (Patent) Challenges for SAPHRIS
Tradename Dosage Ingredient NDA Submissiondate
SAPHRIS TABLET;SUBLINGUAL asenapine maleate 022117 2017-07-27
SAPHRIS TABLET;SUBLINGUAL asenapine maleate 022117 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 ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Allergan SAPHRIS asenapine maleate TABLET;SUBLINGUAL 022117-001 Aug 13, 2009 AB RX Yes No ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Allergan SAPHRIS asenapine maleate TABLET;SUBLINGUAL 022117-003 Mar 12, 2015 AB RX Yes No ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Allergan SAPHRIS asenapine maleate TABLET;SUBLINGUAL 022117-001 Aug 13, 2009 AB RX Yes No ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
>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 022117-003 Mar 12, 2015 ⤷  Try it Free ⤷  Try it Free
Allergan SAPHRIS asenapine maleate TABLET;SUBLINGUAL 022117-002 Aug 13, 2009 ⤷  Try it Free ⤷  Try it Free
Allergan SAPHRIS asenapine maleate TABLET;SUBLINGUAL 022117-001 Aug 13, 2009 ⤷  Try it Free ⤷  Try it Free
>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 CA 2011 00001 Denmark ⤷  Try it Free
0746317 10C0056 France ⤷  Try it Free PRODUCT NAME: ASENAPINE; REGISTRATION NO/DATE: EU/1/10/640/001 20100901
0746317 1090035-5.L Sweden ⤷  Try it Free PRODUCT NAME: ASENAPIN; REG. NO/DATE: EU/1/10/640/001 20100901
0746317 91751 Luxembourg ⤷  Try it Free 91751, EXPIRES: 20200301
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Colorcon
Mallinckrodt
Baxter
Moodys
Johnson and Johnson
McKinsey

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