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Generated: September 23, 2019

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Asenapine maleate - Generic Drug Details

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What are the generic sources for asenapine maleate and what is the scope of asenapine maleate freedom to operate?

Asenapine maleate is the generic ingredient in two branded drugs marketed by Sigmapharm Labs Llc and Forest Labs Llc, and is included in two NDAs. There are three patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Asenapine maleate has thirty-five patent family members in twenty-one countries.

There are twelve drug master file entries for asenapine maleate. One supplier is listed for this compound.

Pharmacology for asenapine maleate
Synonyms for asenapine maleate
(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)
(3aRS,12bRS)-5-Chloro-2-methyl-2,3,3a,12btetrahydro-1Hdibenzo[2,3:6,7]oxepino[4,5-c]pyrrole (2Z)-2-butenedioate
(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
AKOS030228652
API0007678
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/
BCP05157
C17H16ClNO.C4H4O4
CHEBI:71248
CS-0859
CTK5F5413
D02995
EINECS 288-064-8
GMDCDXMAFMEDAG-CHHFXETESA-N
HMS3654L11
HY-11100
MK-8274
MolPort-006-142-524
MolPort-044-724-058
Org 5222
Org-5222
s1283
Saphris
Saphris (TN)
SB17469
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-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 asenapine maleate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sigmapharm Labs Llc ASENAPINE MALEATE asenapine maleate TABLET;SUBLINGUAL 206107-002 Jul 17, 2018 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
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 022117-003 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

Supplementary Protection Certificates for asenapine maleate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0746317 91751 Luxembourg ➤ Sign Up 91751, EXPIRES: 20200301
0746317 122010000050 Germany ➤ Sign Up PRODUCT NAME: ASENAPINHALTIGES ARZNEIMITTEL; REGISTRATION NO/DATE: EU/1/10/640/001-006 20100901
0746317 1090035-5.L Sweden ➤ Sign Up PRODUCT NAME: ASENAPIN; REG. NO/DATE: EU/1/10/640/001 20100901
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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