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Generated: April 26, 2019

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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 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. Two suppliers are listed for this compound. Additional details are available on the asenapine maleate profile page.

Drug patent expirations by year for SAPHRIS
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

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 ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Forest Labs Llc SAPHRIS asenapine maleate TABLET;SUBLINGUAL 022117-001 Aug 13, 2009 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Forest Labs Llc SAPHRIS asenapine maleate TABLET;SUBLINGUAL 022117-003 Mar 12, 2015 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Paragraph IV (Patent) Challenges for SAPHRIS
Drugname Dosage Strength RLD Date
➤ Subscribe Sublingual Tablets 2.5 mg ➤ Subscribe ➤ Sign Up
➤ Subscribe Sublingual Tablets 5 mg and 10 mg ➤ Subscribe ➤ Sign Up

Supplementary Protection Certificates for SAPHRIS

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0746317 122010000050 Germany ➤ Sign Up PRODUCT NAME: ASENAPINHALTIGES ARZNEIMITTEL; REGISTRATION NO/DATE: EU/1/10/640/001-006 20100901
0746317 CA 2011 00001 Denmark ➤ Sign Up
0746317 C00746317/01 Switzerland ➤ Sign Up 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 hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Federal Trade Commission
Queensland Health
Boehringer Ingelheim
Harvard Business School
US Army

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