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Generated: February 22, 2019

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SAMSCA Drug Profile

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When do Samsca patents expire, and what generic alternatives are available?

Samsca is a drug marketed by Otsuka America Pharm and is included in one NDA. There are two patents protecting this drug and two Paragraph IV challenges.

This drug has seventy-five patent family members in nineteen countries.

The generic ingredient in SAMSCA is tolvaptan. There are eight drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the tolvaptan profile page.

Drug patent expirations by year for SAMSCA
Pharmacology for SAMSCA
Synonyms for SAMSCA
(-)-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
(+-)-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
D03KZM
DSSTox_CID_28706
DSSTox_GSID_48780
DSSTox_RID_82975
DTXSID3048780
FT-0645839
GTPL2226
GYHCTFXIZSNGJT-UHFFFAOYSA-N
HE140100
HMS3604L08
HMS3656K20
HSDB 8196
HY-17000
IN2270
jinarc
KB-61802
KS-1315
L001628
MFCD09837707
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 (TN)
Samsca;OPC-41061
SCHEMBL242421
SR-01000942265
SR-01000942265-1
ST24031322
TC-148610
Tolvaptan
Tolvaptan (OPC-41061)
Tolvaptan [USAN:INN:BAN]
Tolvaptan, >=98% (HPLC), powder
Tox21_113256

US Patents and Regulatory Information for SAMSCA

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 022275-001 May 19, 2009 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Otsuka America Pharm SAMSCA tolvaptan TABLET;ORAL 022275-002 May 19, 2009 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ 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 ➤ Try a Free Trial
Otsuka America Pharm SAMSCA tolvaptan TABLET;ORAL 022275-002 May 19, 2009 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ 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 ➤ 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
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 SAMSCA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
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 022275-003 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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Paragraph IV (Patent) Challenges for SAMSCA
Drugname Dosage Strength RLD Date
➤ Subscribe Tablets 60 mg ➤ Subscribe ➤ Try a Free Trial
➤ Subscribe Tablets 15 mg and 30 mg ➤ Subscribe ➤ Try a Free Trial

Supplementary Protection Certificates for SAMSCA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0049 France ➤ Try a Free Trial PRODUCT NAME: TOLVAPTAN, EVENTUELLEMENT SOUS FORME DE SEL; REGISTRATION NO/DATE: EU/1/09/539/001 20090803
2009 00031 Denmark ➤ Try a Free Trial
C/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
00408 Netherlands ➤ Try a Free Trial PRODUCT NAME: TOLVAPTAN, DESGEWENST IN DE VORM VAN EEN ZOUT; REGISTRATION NO/DATE: EU/1/09/539/001-004 20090803
0408 Netherlands ➤ Try a Free Trial 300408, 20101018, EXPIRES: 20151017
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
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McKinsey
Johnson and Johnson
Express Scripts
Chubb
Moodys
US Department of Justice
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