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Generated: July 22, 2019

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Tolvaptan - Generic Drug Details

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What are the generic drug sources for tolvaptan and what is the scope of tolvaptan freedom to operate?

Tolvaptan is the generic ingredient in two branded drugs marketed by Otsuka Pharm Co Ltd and Otsuka America Pharm, and is included in two NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Tolvaptan has seventy-five patent family members in nineteen countries.

There are eight drug master file entries for tolvaptan. One supplier is listed for this compound.

Pharmacology for tolvaptan
Synonyms for tolvaptan
(+-)-4'-((7-Chloro-2,3,4,5-tetrahydro-5-hydroxy-1H-1-benzazepin-1-yl) carbonyl)-o-tolu-m-toluidide
(+-)-4'-((7-Chloro-2,3,4,5-tetrahydro-5-hydroxy-1H-1-benzazepin-1-yl)carbonyl)-o-tolu-m-toluidide
150683-30-0
4CA-1265
5-hydroxy-7-chloro-1-[2-methyl-4-(2-methylbenzoylamino)benzoyl]-2,3,4,5-tetrahydro-1h-benzazepine
683T300
7-Chloro-5-hydroxy-1-(2-methyl-4-(2-methylbenzoylamino)benzoyl)2,3,4,5-tetrahydro-1H-1-benzazepine
7-chloro-5-hydroxy-1-[2-methyl-4-(2-methyl benzoyl amino) benzoyl]-2,3,4,5-tetrahydro-1H-1-benzazepine
7-chloro-5-hydroxy-1-[2-methyl-4-(2-methylbenzoylamino) benzoyl]-2,3,4,5-tetrahydro-1H-1-benzazepine
7-chloro-5-hydroxy-1-[2-methyl-4-(2-methylbenzoylamino)benzoyl]-2,3,4,5-tetrahydro-1H-1-benzazepine
AB0009995
AB01565822_02
AB2000685
AC-22748
AC1L50C9
AK-33401
AKOS015994735
AM20090726
AN-5238
ANW-59865
API0024498
AX8158397
BC650606
BDBM35723
Benzamide, N-(4-((7-chloro-2,3,4,5-tetrahydro-5-hydroxy-1H-1-benzazepin-1-yl)carbonyl)-3-methylphenyl)-2-methyl-
Benzamide, N-[4-[(7-chloro-2,3,4,5-tetrahydro-5-hydroxy-1H-1-benzazepin-1-yl)carbonyl]-3-methylphenyl]-2-methyl-
benzazepine derivative, 32
C26H25ClN2O3
CAS-150683-30-0
CHEBI:32246
CHEMBL344159
CS-0572
CT0200
CTK8B8272
DSSTox_CID_28706
DSSTox_GSID_48780
DSSTox_RID_82975
DTXSID3048780
FT-0645839
GTPL2226
GYHCTFXIZSNGJT-UHFFFAOYSA-N
HMS3604L08
HMS3656K20
HSDB 8196
HY-17000
KB-61802
KS-1315
L001628
MolPort-008-155-996
N-(4-(7-Chloro-5-hydroxy-2,3,4,5-tetrahydro-1H-benzo[b]-azepine-1-carbonyl)-3-methylphenyl)-2-methylbenzamide
N-(4-(7-Chloro-5-hydroxy-2,3,4,5-tetrahydro-1H-benzo[b]azepine-1-carbonyl)-3-methylphenyl)-2-methylbenzamide
N-[4-(7-chloro-5-hydroxy-2,3,4,5-tetrahydro-1-benzazepine-1-carbonyl)-3-methyl-phenyl]-2-methyl-benzamide
N-[4-(7-chloro-5-hydroxy-2,3,4,5-tetrahydro-1-benzazepine-1-carbonyl)-3-methylphenyl]-2-methylbenzamide
N-[4-(7-Chloro-5-hydroxy-2,3,4,5-tetrahydro-benzo[b]azepine-1-carbonyl)-3-methyl-phenyl]-2-methyl-benzamide
N-[4-(7-chloro-5-hydroxy2,3,4,5-tetrahydro-1-benzazepine-1-carbonyl)-3-methylphenyl]-2-methylbenzamide
N-[4-(9-chloro-6-hydroxy-2-azabicyclo[5.4.0]undeca-8,10,12-triene-2-carbonyl)-3-methyl-phenyl]-2-methyl-benzamide
N-[4-[(7-Chloro-2,3,4,5-tetrahydro-5-hydroxy-1H-1-benzazepin-1-yl)carbonyl]-3-methylphenyl]-2-methylbenzamide
NCGC00183001-01
OPC 41061
OPC-41061
PDSP1_001738
PDSP2_001721
s2593
Samsca
Samsca;OPC-41061
SCHEMBL242421
SR-01000942265
SR-01000942265-1
ST24031322
SW219182-1
TC-148610
Tolvaptan (OPC-41061)
Tolvaptan [USAN:INN:BAN]
Tolvaptan, >=98% (HPLC), powder
Tox21_113256

US Patents and Regulatory Information for tolvaptan

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Otsuka Pharm Co Ltd JYNARQUE tolvaptan TABLET;ORAL 204441-002 Apr 23, 2018 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Otsuka America Pharm SAMSCA tolvaptan TABLET;ORAL 022275-003 May 19, 2009 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Otsuka America Pharm SAMSCA tolvaptan TABLET;ORAL 022275-001 May 19, 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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Expired US Patents for tolvaptan

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Otsuka Pharm Co Ltd JYNARQUE tolvaptan TABLET;ORAL 204441-004 Apr 23, 2018 ➤ Try a Free Trial ➤ Try a Free Trial
Otsuka America Pharm SAMSCA tolvaptan TABLET;ORAL 022275-001 May 19, 2009 ➤ Try a Free Trial ➤ Try a Free Trial
Otsuka America Pharm SAMSCA tolvaptan TABLET;ORAL 022275-002 May 19, 2009 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for tolvaptan

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0450097 300408 Netherlands ➤ Try a Free Trial 300408, 20101018, EXPIRES: 20151017
0450097 SPC/GB09/037 United Kingdom ➤ Try a Free Trial PRODUCT NAME: TOLVAPTAN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: UK EU/1/09/539/001 20090803; UK EU/1/09/539/002 20090803; UK EU/1/09/539/003 20090803; UK EU/1/09/539/004 20090803
0450097 09C0049 France ➤ Try a Free Trial PRODUCT NAME: TOLVAPTAN, EVENTUELLEMENT SOUS FORME DE SEL; REGISTRATION NO/DATE: EU/1/09/539/001 20090803
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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