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Last Updated: March 28, 2024

SAMSCA Drug Patent Profile


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Which patents cover Samsca, and what generic alternatives are available?

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

This drug has eighty-six patent family members in twenty-four countries.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Samsca

A generic version of SAMSCA was approved as tolvaptan by ALKEM LABS LTD on May 19th, 2020.

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Drug patent expirations by year for SAMSCA
Drug Prices for SAMSCA

See drug prices for SAMSCA

Recent Clinical Trials for SAMSCA

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

SponsorPhase
Gia Dinh People HospitalN/A
Otsuka Pharmaceutical VietnamN/A
Chinese Pulmonary Vascular Disease Research GroupN/A

See all SAMSCA clinical trials

Pharmacology for SAMSCA
Anatomical Therapeutic Chemical (ATC) Classes for SAMSCA
Paragraph IV (Patent) Challenges for SAMSCA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
SAMSCA Tablets tolvaptan 60 mg 022275 1 2018-03-26
SAMSCA Tablets tolvaptan 15 mg 022275 1 2013-10-10
SAMSCA Tablets tolvaptan 30mg 022275 1 2013-09-23

US Patents and Regulatory Information for SAMSCA

SAMSCA is protected by two US patents.

Patents protecting SAMSCA

Pharmaceutical solid preparation comprising benzazepines and production method thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Process for preparing benzazepine compounds or salts thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Otsuka SAMSCA tolvaptan TABLET;ORAL 022275-001 May 19, 2009 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Otsuka SAMSCA tolvaptan TABLET;ORAL 022275-002 May 19, 2009 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Otsuka SAMSCA tolvaptan TABLET;ORAL 022275-001 May 19, 2009 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Otsuka SAMSCA tolvaptan TABLET;ORAL 022275-002 May 19, 2009 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Otsuka SAMSCA tolvaptan TABLET;ORAL 022275-003 May 19, 2009 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Otsuka SAMSCA tolvaptan TABLET;ORAL 022275-003 May 19, 2009 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a 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 SAMSCA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Otsuka SAMSCA tolvaptan TABLET;ORAL 022275-001 May 19, 2009 ⤷  Try a Trial ⤷  Try a Trial
Otsuka SAMSCA tolvaptan TABLET;ORAL 022275-003 May 19, 2009 ⤷  Try a Trial ⤷  Try a Trial
Otsuka SAMSCA tolvaptan TABLET;ORAL 022275-002 May 19, 2009 ⤷  Try a Trial ⤷  Try a Trial
Otsuka SAMSCA tolvaptan TABLET;ORAL 022275-003 May 19, 2009 ⤷  Try a Trial ⤷  Try a Trial
Otsuka SAMSCA tolvaptan TABLET;ORAL 022275-001 May 19, 2009 ⤷  Try a Trial ⤷  Try a Trial
Otsuka SAMSCA tolvaptan TABLET;ORAL 022275-002 May 19, 2009 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for SAMSCA

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Otsuka Pharmaceutical Netherlands B.V. Jinarc tolvaptan EMEA/H/C/002788
Jinarc is indicated to slow the progression of cyst development and renal insufficiency of autosomal dominant polycystic kidney disease (ADPKD) in adults with CKD stage 1 to 3 at initiation of treatment with evidence of rapidly progressing disease.
Authorised no no no 2015-05-27
Otsuka Pharmaceutical Netherlands B.V. Samsca tolvaptan EMEA/H/C/000980
Treatment of adult patients with hyponatraemia secondary to syndrome of inappropriate antidiuretic-hormone secretion (SIADH).,
Authorised no no no 2009-08-02
Accord Healthcare S.L.U. Tolvaptan Accord tolvaptan EMEA/H/C/005961
Tolvaptan is indicated in adults for the treatment of hyponatremia secondary to the syndrome of inappropriate antidiuretic hormone secretion (SIADH).
Authorised yes no no
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for SAMSCA

When does loss-of-exclusivity occur for SAMSCA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Austria

Patent: 96895
Estimated Expiration: ⤷  Try a Trial

Patent: 44744
Estimated Expiration: ⤷  Try a Trial

China

Patent: 1273017
Estimated Expiration: ⤷  Try a Trial

Patent: 1967107
Estimated Expiration: ⤷  Try a Trial

Patent: 2219741
Estimated Expiration: ⤷  Try a Trial

Patent: 2746229
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 11788
Estimated Expiration: ⤷  Try a Trial

Patent: 12496
Estimated Expiration: ⤷  Try a Trial

Patent: 16082
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 19874
Estimated Expiration: ⤷  Try a Trial

Patent: 51319
Estimated Expiration: ⤷  Try a Trial

Patent: 61215
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 19874
Estimated Expiration: ⤷  Try a Trial

Patent: 51319
Estimated Expiration: ⤷  Try a Trial

Patent: 61215
Estimated Expiration: ⤷  Try a Trial

Germany

Patent: 2006019882
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 24318
Estimated Expiration: ⤷  Try a Trial

Patent: 44932
Estimated Expiration: ⤷  Try a Trial

Patent: 45835
Estimated Expiration: ⤷  Try a Trial

Patent: 48999
Estimated Expiration: ⤷  Try a Trial

Patent: 72329
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 9481
Estimated Expiration: ⤷  Try a Trial

Patent: 7444
Estimated Expiration: ⤷  Try a Trial

Patent: 7445
Estimated Expiration: ⤷  Try a Trial

Patent: 7446
Estimated Expiration: ⤷  Try a Trial

Patent: 2396
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 46587
Estimated Expiration: ⤷  Try a Trial

Patent: 83172
Estimated Expiration: ⤷  Try a Trial

Patent: 84164
Estimated Expiration: ⤷  Try a Trial

Patent: 93083
Estimated Expiration: ⤷  Try a Trial

Patent: 07091738
Estimated Expiration: ⤷  Try a Trial

Patent: 12176979
Estimated Expiration: ⤷  Try a Trial

Patent: 12197295
Estimated Expiration: ⤷  Try a Trial

Patent: 12197296
Estimated Expiration: ⤷  Try a Trial

Patent: 14139203
Estimated Expiration: ⤷  Try a Trial

Patent: 14205699
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 19874
Estimated Expiration: ⤷  Try a Trial

Patent: 51319
Estimated Expiration: ⤷  Try a Trial

Patent: 61215
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 19874
Estimated Expiration: ⤷  Try a Trial

Patent: 51319
Estimated Expiration: ⤷  Try a Trial

Patent: 61215
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 19874
Estimated Expiration: ⤷  Try a Trial

Patent: 51319
Estimated Expiration: ⤷  Try a Trial

Patent: 61215
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1019363
Estimated Expiration: ⤷  Try a Trial

Patent: 1077329
Estimated Expiration: ⤷  Try a Trial

Patent: 1119732
Estimated Expiration: ⤷  Try a Trial

Patent: 080039459
Estimated Expiration: ⤷  Try a Trial

Patent: 100132087
Estimated Expiration: ⤷  Try a Trial

Patent: 100133028
Estimated Expiration: ⤷  Try a Trial

Patent: 110029184
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 58217
Estimated Expiration: ⤷  Try a Trial

Patent: 79153
Estimated Expiration: ⤷  Try a Trial

Patent: 27794
Estimated Expiration: ⤷  Try a Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering SAMSCA around the world.

Country Patent Number Title Estimated Expiration
Cyprus 1112496 ⤷  Try a Trial
Taiwan 200911270 Pharmaceutical solid preparation and production method thereof ⤷  Try a Trial
Portugal 2167046 ⤷  Try a Trial
Cyprus 1111788 ⤷  Try a Trial
Japan H04321669 VASOPRESSIN ANTAGONISTIC AGENT ⤷  Try a Trial
Hong Kong 1172329 製備苯並氮雜䓬化合物或其鹽的方法 (PROCESS FOR PREPARING BENZAZEPINE COMPOUNDS OR SALTS THEREOF) ⤷  Try a Trial
Russian Federation 2466717 ФАРМАЦЕВТИЧЕСКИЙ ТВЕРДЫЙ ПРЕПАРАТ, СОДЕРЖАЩИЙ БЕНЗОАЗЕПИНЫ, И СПОСОБ ЕГО ПОЛУЧЕНИЯ (PHARMACEUTICAL SOLID PREPARATION CONTAINING BENZAZEPIN AND METHOD FOR PREPARING IT) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for SAMSCA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0450097 300408 Netherlands ⤷  Try a Trial 300408, 20101018, EXPIRES: 20151017
0450097 SPC/GB09/037 United Kingdom ⤷  Try a 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 C300408 Netherlands ⤷  Try a Trial PRODUCT NAME: TOLVAPTAN, DESGEWENST IN DE VORM VAN EEN ZOUT; REGISTRATION NO/DATE: EU/1/09/539/001-004 20090803
0450097 09C0049 France ⤷  Try a Trial PRODUCT NAME: TOLVAPTAN, EVENTUELLEMENT SOUS FORME DE SEL; REGISTRATION NO/DATE: EU/1/09/539/001 20090803
0450097 CA 2009 00031 Denmark ⤷  Try a Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.