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Last Updated: December 5, 2020

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SAPHRIS Drug 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 three patents protecting this drug and two Paragraph IV challenges.

This drug has thirty-five patent family members in twenty-one countries.

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

US ANDA Litigation and Generic Entry Outlook for Saphris

Saphris was eligible for patent challenges on August 13, 2013.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 6, 2026. This may change due to patent challenges or generic licensing.

There have been four patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (asenapine maleate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Drug patent expirations by year for SAPHRIS
Drug Prices for SAPHRIS

See drug prices for SAPHRIS

Generic Entry Opportunity Date for SAPHRIS
Generic Entry Date for SAPHRIS*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;SUBLINGUAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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 LouisvillePhase 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 RX Yes No   Start Trial   Start Trial Y   Start Trial
Allergan SAPHRIS asenapine maleate TABLET;SUBLINGUAL 022117-001 Aug 13, 2009 RX Yes No   Start Trial   Start Trial Y   Start Trial
Allergan SAPHRIS asenapine maleate TABLET;SUBLINGUAL 022117-003 Mar 12, 2015 RX Yes No   Start Trial   Start Trial   Start Trial
Allergan SAPHRIS asenapine maleate TABLET;SUBLINGUAL 022117-002 Aug 13, 2009 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Allergan SAPHRIS asenapine maleate TABLET;SUBLINGUAL 022117-001 Aug 13, 2009 RX Yes No   Start Trial   Start Trial Y   Start Trial
Allergan SAPHRIS asenapine maleate TABLET;SUBLINGUAL 022117-002 Aug 13, 2009 RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for SAPHRIS

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0746317 CA 2011 00001 Denmark   Start Trial
0746317 SPC032/2010 Ireland   Start Trial SPC032/2010: 20101210, EXPIRES: 20200228
0746317 1090035-5.L Sweden   Start Trial PRODUCT NAME: ASENAPIN; REG. NO/DATE: EU/1/10/640/001 20100901
0746317 91751 Luxembourg   Start Trial 91751, EXPIRES: 20200301
0746317 C00746317/01 Switzerland   Start Trial PRODUCT NAME: ASENAPINUM; REGISTRATION NO/DATE: SWISSMEDIC 62073 20.07.2012
0746317 SPC/GB10/046 United Kingdom   Start Trial 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.