Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 19, 2019

DrugPatentWatch Database Preview

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 Forest Labs Llc 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.

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
Accutest Research Laboratories (I) Pvt. Ltd.Phase 2/Phase 3
Amneal Pharmaceuticals, LLCPhase 2/Phase 3
University of LouisvillePhase 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[12.4.0.0^{2,6}.0^{7,12}]octadeca-1(14),7(12),8,10,15,17-hexaene; maleic acid
(3aR,12bR)-rel-5-Chloro-2,3,3a,12b-tetrahydro-2-methyl-1Hdibenzo[2,3:6,7]oxepino[4,5-c]pyrrole,(2Z)-2-butenedioate(1:1)
(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)
650A562
65576-45-6, 135883-08-8 (Maleic acid)
85650-56-2
AB1008436
ABP000604
AC-24116
AKOS015951084
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)
Asenapine/
C17H16ClNO.C4H4O4
CHEBI:71248
CS-0859
D02995
EINECS 288-064-8
GMDCDXMAFMEDAG-CHHFXETESA-N
HY-11100
MK-8274
MolPort-006-142-524
Org 5222
Org-5222
s1283
Saphris (TN)
SC-82643
SCH-900274
SCHEMBL175228
SW219879-1
Sycrest
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
UNII-CU9463U2E2 component GMDCDXMAFMEDAG-CHHFXETESA-N
W-5202
X2936
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
Forest Labs Llc SAPHRIS asenapine maleate TABLET;SUBLINGUAL 022117-003 Mar 12, 2015 RX Yes No   Start Trial   Start Trial Y   Start Trial
Forest Labs Llc SAPHRIS asenapine maleate TABLET;SUBLINGUAL 022117-001 Aug 13, 2009 RX Yes No   Start Trial   Start Trial Y   Start Trial
Forest Labs Llc SAPHRIS asenapine maleate TABLET;SUBLINGUAL 022117-003 Mar 12, 2015 RX Yes No   Start Trial   Start Trial   Start Trial
Forest Labs Llc SAPHRIS asenapine maleate TABLET;SUBLINGUAL 022117-002 Aug 13, 2009 RX Yes Yes   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 CA 2011 00001 Denmark   Start Trial
0746317 91751 Luxembourg   Start Trial 91751, EXPIRES: 20200301
0746317 1090035-5.L Sweden   Start Trial PRODUCT NAME: ASENAPIN; REG. NO/DATE: EU/1/10/640/001 20100901
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
Mallinckrodt
Dow
AstraZeneca
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McKesson

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