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Last Updated: January 26, 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. One supplier is 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 five 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:

*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

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

Recent Litigation for SAPHRIS

Identify potential future generic entrants

District Court Litigation
Case NameDate
Forest Laboratories, LLC v. Breckenridge Pharmaceutical, Inc.2017-09-08
Forest Laboratories LLC v. Breckenridge Pharmaceutical Inc.2014-12-23
Forest Laboratories, LLC v. Hikma Pharmaceuticals LLC2014-10-02

See all SAPHRIS litigation

Pharmacology for SAPHRIS
Synonyms for SAPHRIS
(2S,6S)-9-chloro-4-methyl-13-oxa-4-azatetracyclo[^{2,6}.0^{7,12}]octadeca-1(14),7(12),8,10,15,17-hexaene; maleic acid
(3aRS,12bRS)-5-chloro-2-methyl-2,3,3a,12b-tetrahydro-1H-dibenzo(2,3:6,7)oxepino(4,5-c)pyrrole (2Z)-2-butenedioate (1:1)
(3aS,12bS)-5-chloro-2-methyl-2,3,3a,12b-tetrahydro-1H-dibenzo[2,3:6,7]oxepino[4,5-c]pyrrole maleate
(S,S)-Asenapine Maleate
1H-Dibenz(2,3:6,7)oxepino(4,5-c)pyrrole, 5-chloro-2,3,3a,12b-tetrahydro-2-methyl-, (3aR,12bR)-rel-, (2Z)-2-butenedioate (1:1)
1H-Dibenz(2,3:6,7)oxepino(4,5-c)pyrrole, 5-chloro-2,3,3a,12b-tetrahydro-2-methyl-,(3aR,12bR)-rel-, (2Z)-2-butenedioate (1:1)
65576-45-6, 135883-08-8 (Maleic acid)
Asenapine (maleate)
Asenapine maleate
Asenapine maleate (JAN/USAN)
Asenapine maleate [USAN]
Asenapine Maleate 1.0 mg/ml in Methanol (as free base)
Asenapine maleate, >=98% (HPLC)
EINECS 288-064-8
Org 5222
Saphris (TN)
trans-5-Chloro-2-methyl-2,3,3a,12b-tetrahydro-1H-dibenzo[2,3:6,7]oxepino[4,5-c]pyrrole maleate
trans-5-Chloro-2,3,3a,12b-tetrahydro-2-methyl-1H-dibenz(2,3:6,7)oxepino(4,5-c)pyrrole maleate
trans-5-chloro-2,3,3a,12b-tetrahydro-2-methyl-1H-dibenzo[2,3;6,7]-oxepino[4,5-c]pyrrole maleate
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
>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 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
0746317 SZ 39/2010 Austria   Start Trial
0746317 10C0056 France   Start Trial PRODUCT NAME: ASENAPINE; REGISTRATION NO/DATE: EU/1/10/640/001 20100901
0746317 SPC032/2010 Ireland   Start Trial SPC032/2010: 20101210, EXPIRES: 20200228
0746317 C00746317/01 Switzerland   Start Trial PRODUCT NAME: ASENAPINUM; REGISTRATION NO/DATE: SWISSMEDIC 62073 20.07.2012
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Harvard Business School
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