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Last Updated: December 8, 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 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. Two suppliers are listed for this compound.

Recent Clinical Trials for tolvaptan

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Otsuka Pharmaceutical Europe LtdPhase 2
Assistance Publique - Hôpitaux de ParisPhase 2
Azienda Ospedaliero-Universitaria ConsorzialePhase 3

See all tolvaptan clinical trials

Recent Litigation for tolvaptan

Identify potential future generic entrants

District Court Litigation
Case NameDate
Otsuka Pharmaceutical Co., Ltd. v. Alkem Laboratories Ltd.2018-06-29
Otsuka Pharmaceutical Co. Ltd. v. Par Pharmaceutical Inc.2014-06-20
Otsuka Pharmaceutical Co. Ltd. v. Hetero USA Inc.2014-04-04

See all tolvaptan litigation

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
Paragraph IV (Patent) Challenges for TOLVAPTAN
Tradename Dosage Ingredient NDA Submissiondate
SAMSCA TABLET;ORAL tolvaptan 022275 2018-03-26
SAMSCA TABLET;ORAL tolvaptan 022275 2013-10-10
SAMSCA TABLET;ORAL tolvaptan 022275 2013-09-23

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

Expired US Patents for tolvaptan

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Otsuka America Pharm SAMSCA tolvaptan TABLET;ORAL 022275-002 May 19, 2009   Start Trial   Start Trial
Otsuka America Pharm SAMSCA tolvaptan TABLET;ORAL 022275-003 May 19, 2009   Start Trial   Start Trial
Otsuka Pharm Co Ltd JYNARQUE tolvaptan TABLET;ORAL 204441-001 Apr 23, 2018   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for tolvaptan

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0450097 SPC/GB09/037 United Kingdom   Start 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 300408 Netherlands   Start Trial 300408, 20101018, EXPIRES: 20151017
0450097 CA 2009 00031 Denmark   Start Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKinsey
Johnson and Johnson
Medtronic
Baxter
Dow
AstraZeneca

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