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Generated: July 16, 2018

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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 one branded drug marketed by Forest Labs Llc and is included in one NDA. 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. Two suppliers are listed for this compound.
Pharmacology for asenapine maleate
Synonyms for asenapine maleate
(2R,6R)-9-CHLORO-4-METHYL-13-OXA-4-AZATETRACYCLO[12.4.0.0(2),?.0?,(1)(2)]OCTADECA-1(14),7(12),8,10,15,17-HEXAENE; (2Z)-BUT-2-ENEDIOIC ACID
(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)-5-chloro-2-methyl-2,3,3a,12b-tetrahydro-1H-dibenzo[2,3:6,7]oxepino[4,5-c]pyrrol-2-ium (2Z)-3-prop-2-enoate
(3aR,12bR)-5-chloro-2-methyl-2,3,3a,12b-tetrahydro-1H-dibenzo[2,3:6,7]oxepino[4,5-c]pyrrole (2Z)-but-2-enedioate
(3aR,12bR)-5-chloro-2-methyl-2,3,3a,12b-tetrahydro-1H-dibenzo[2,3:6,7]oxepino[4,5-c]pyrrole maleate
(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
(R,R)-asenapine 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)
5-chloro-2-methyl-2,3,3a,12b-tetrahydro-1H-dibenzo[2,3:6,7]oxepino[4,5-c]pyrrole maleate
650A562
65576-45-6, 135883-08-8 (Maleic acid)
85650-56-2
AB1008436
ABP000604
AC-24116
AK326201
AKOS015951084
AKOS026750280
AN-16963
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/
asenapinemaleate
C17H16ClNO.C4H4O4
CCG-220195
CHEBI:71246
CHEBI:71248
CHEMBL3544974
CS-0859
D02995
DB06216
EINECS 288-064-8
FT-0686950
GMDCDXMAFMEDAG-BTJKTKAUSA-N
GMDCDXMAFMEDAG-CHHFXETESA-N
HY-11100
KS-000011GR
MFCD00900588
MK-8274
MLS004774144
MLS006011942
MolPort-006-142-524
MolPort-044-724-058
Org 5222
Org-5222
PL008086
s1283
Saphris
Saphris (TN)
SC-82643
SCH-900274
SCHEMBL175228
SCHEMBL524851
SCHEMBL6029138
SMR003500788
SMR004703525
SR-01000939499
SR-01000939499-2
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
UNII-CU9463U2E2 component GMDCDXMAFMEDAG-TXUHOWFZSA-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
Forest Labs Llc SAPHRIS asenapine maleate TABLET;SUBLINGUAL 022117-001 Aug 13, 2009 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Forest Labs Llc SAPHRIS asenapine maleate TABLET;SUBLINGUAL 022117-001 Aug 13, 2009 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Forest Labs Llc SAPHRIS asenapine maleate TABLET;SUBLINGUAL 022117-002 Aug 13, 2009 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Forest Labs Llc SAPHRIS asenapine maleate TABLET;SUBLINGUAL 022117-001 Aug 13, 2009 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
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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Supplementary Protection Certificates for asenapine maleate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2010000050 Germany ➤ Try a Free Trial PRODUCT NAME: ASENAPINHALTIGES ARZNEIMITTEL; REGISTRATION NO/DATE: EU/1/10/640/001-006 20100901
C/GB10/046 United Kingdom ➤ Try a Free 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
0746317/01 Switzerland ➤ Try a Free Trial PRODUCT NAME: ASENAPINUM; REGISTRATION NO/DATE: SWISSMEDIC 62073 20.07.2012
90035-5.L Sweden ➤ Try a Free Trial PRODUCT NAME: ASENAPIN; REG. NO/DATE: EU/1/10/640/001 20100901
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Queensland Health
Merck
Chinese Patent Office
Cerilliant
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Fish and Richardson
Deloitte

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