Get our Free Drug Patent Expiration Updates

Serving hundreds of leading biopharmaceutical companies globally:

UBS
Fish and Richardson
Teva
Chubb
Queensland Health
Federal Trade Commission
McKesson
Fuji
Boehringer Ingelheim

Generated: December 14, 2018

DrugPatentWatch Database Preview

SAPHRIS Drug Profile

« Back to Dashboard

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
AK326201
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/
asenapinemaleate
C17H16ClNO.C4H4O4
CHEBI:71248
CS-0859
D02995
EINECS 288-064-8
GMDCDXMAFMEDAG-CHHFXETESA-N
HY-11100
MFCD00900588
MK-8274
MolPort-006-142-524
Org 5222
Org-5222
s1283
Saphris (TN)
SC-82643
SCH-900274
SCHEMBL175228
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 022117-002 Aug 13, 2009 AB RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Forest Labs Llc SAPHRIS asenapine maleate TABLET;SUBLINGUAL 022117-001 Aug 13, 2009 AB 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

This preview shows a limited data set.
Subscribe to access the full database, or try a Free Trial

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

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C032/2010 Ireland ➤ Sign Up SPC032/2010: 20101210, EXPIRES: 20200228
2011 00001 Denmark ➤ Sign Up
C/GB10/046 United Kingdom ➤ Sign Up 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
C0056 France ➤ Sign Up PRODUCT NAME: ASENAPINE; REGISTRATION NO/DATE: EU/1/10/640/001 20100901
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

This preview shows a limited data set.
Subscribe to access the full database, or try a Free Trial

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Moodys
Chubb
Farmers Insurance
Argus Health
McKesson
Johnson and Johnson
Colorcon
Mallinckrodt
Baxter

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 verifification 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.