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Last Updated: January 31, 2023

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 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 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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Allergan SAPHRIS asenapine maleate TABLET;SUBLINGUAL 022117-001 Aug 13, 2009 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Allergan SAPHRIS asenapine maleate TABLET;SUBLINGUAL 022117-003 Mar 12, 2015 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Allergan SAPHRIS asenapine maleate TABLET;SUBLINGUAL 022117-001 Aug 13, 2009 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Allergan SAPHRIS asenapine maleate TABLET;SUBLINGUAL 022117-002 Aug 13, 2009 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Allergan SAPHRIS asenapine maleate TABLET;SUBLINGUAL 022117-002 Aug 13, 2009 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 022117-002 Aug 13, 2009 See Plans and Pricing See Plans and Pricing
Allergan SAPHRIS asenapine maleate TABLET;SUBLINGUAL 022117-003 Mar 12, 2015 See Plans and Pricing See Plans and Pricing
Allergan SAPHRIS asenapine maleate TABLET;SUBLINGUAL 022117-001 Aug 13, 2009 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for SAPHRIS

See the table below for patents covering SAPHRIS around the world.

Country Patent Number Title Estimated Expiration
Czech Republic 284633 Farmaceutický prostředek a použití trans-5-chloro-2-methyl-2,3,3a,12b-tetrahydro-1H-dibenz[2,3:6,7]oxepino[4,5-c]pyrrolu pro výrobu farmaceutického prostředku (PHARMACEUTICAL PREPARATION AND USE OF TRANS-5-CHLORO-2-METHYL-2,3,3a,12b-TETRAHYDRO-1H-DIBENZ[2,3:6,7]OXEPINO [4,5-c]PYRROLE FOR PREPARING THE PHARMACEUTICAL PREPARATION) See Plans and Pricing
Japan 4616810 See Plans and Pricing
Hungary 225051 SUBLINGUAL OR BUCCAL PHARMACEUTICAL COMPOSITIONS CONTAINING TRANS-5-CHLORO-2-METHYL-2,3,3A,12B-TETRAHYDRO-1H-DIBENZ[2,3:6,7]OXEPINO[4,5-C]PYRROLE See Plans and Pricing
Luxembourg 91751 See Plans and Pricing
Canada 2182981 COMPOSITION PHARMACEUTIQUE SUBLINGUALE OU BUCCALE (SUBLINGUAL OR BUCCAL PHARMACEUTICAL COMPOSITION) See Plans and Pricing
Australia 1947895 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for SAPHRIS

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0746317 C00746317/01 Switzerland See Plans and Pricing PRODUCT NAME: ASENAPINUM; REGISTRATION NO/DATE: SWISSMEDIC 62073 20.07.2012
0746317 1090035-5.L Sweden See Plans and Pricing PRODUCT NAME: ASENAPIN; REG. NO/DATE: EU/1/10/640/001 20100901
0746317 91751 Luxembourg See Plans and Pricing 91751, EXPIRES: 20200301
0746317 SZ 39/2010 Austria See Plans and Pricing
0746317 CA 2011 00001 Denmark See Plans and Pricing
0746317 SPC/GB10/046 United Kingdom See Plans and Pricing 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.