SAMSCA Drug Patent Profile

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 19^th, 2020.

Summary for SAMSCA

International Patents:	86
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	101
Clinical Trials:	37
Patent Applications:	1,299
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for SAMSCA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SAMSCA
What excipients (inactive ingredients) are in SAMSCA?	SAMSCA excipients list
DailyMed Link:	SAMSCA at DailyMed

See drug prices for SAMSCA

Recent Clinical Trials for SAMSCA

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

Sponsor	Phase
Otsuka Pharmaceutical Vietnam	N/A
Gia Dinh People Hospital	N/A
Chinese Pulmonary Vascular Disease Research Group	N/A

See all SAMSCA clinical trials

Pharmacology for SAMSCA

Drug Class	Vasopressin V2 Receptor Antagonist
Mechanism of Action	Vasopressin V2 Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for SAMSCA

C03XA	Vasopressin antagonists
C03X	OTHER DIURETICS
C03	DIURETICS
C	Cardiovascular system

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

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				Y
Otsuka	SAMSCA	tolvaptan	TABLET;ORAL	022275-002	May 19, 2009	AB	RX	Yes	Yes			Y
Otsuka	SAMSCA	tolvaptan	TABLET;ORAL	022275-001	May 19, 2009	AB	RX	Yes	No			Y
Otsuka	SAMSCA	tolvaptan	TABLET;ORAL	022275-002	May 19, 2009	AB	RX	Yes	Yes				Y
Otsuka	SAMSCA	tolvaptan	TABLET;ORAL	022275-003	May 19, 2009		DISCN	Yes	No				Y
Otsuka	SAMSCA	tolvaptan	TABLET;ORAL	022275-003	May 19, 2009		DISCN	Yes	No			Y

Expired US Patents for SAMSCA

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

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

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

China

Cyprus

Denmark

European Patent Office

Germany

Hong Kong

Israel

Japan

Poland

Portugal

Slovenia

South Korea

Spain

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
Israel	217446	תכשיר רוקחי המכיל מרכיב פעיל מטוהר מאוד של 7- כלורו - 5 - הידרוקסי- 1- [2-מתיל-4-(2-מתילבנזואיל-אמינו)בנזואיל]-2, 3, 4, 5 - טטראהידרו- h 1 - 1 - בנזאזפין בעל טוהר של יותר מ - 99.5% או מלח שלו, או תכשיר רוקחות של מלח שלו (Pharmaceutical composition comprising as an active ingredient a highly pure 7-chloro-5-hydroxy-1-[2-methyl-4-(2-methyl¬benzoyl¬amino)benzoyl]-2,3,4,5-tetrahydro-1h-1-benzazepine having a purity of more than 99.5 %, or a salt thereof, or a pharmaceutically acceptable salt thereof)
Spain	2358217
Poland	2251319
Cyprus	1116082
Israel	189481	תהליך עבור הפקת תרכובות 2,3,4,5-טטרההידרו-h1-1-בנזאזפין או מלחים מזה ותרכובת נקייה מאוד המופקת על ידי תהליך האמור (Process for producing 2,3,4,5-tetrahydro-1h-1- benzazepine compounds or salts thereof and highly pure compounds produced by said process)
European Patent Office	0450097	COMPOSES BENZOHETEROCYCLIQUES (BENZOHETEROCYCLIC COMPOUNDS)
Hong Kong	1201719	包含苯並氮雜䓬的藥物固體製劑及其生產方法 (PHARMACEUTICAL SOLID PREPARATION COMPRISING BENZAZEPINES AND PRODUCTION METHOD THEREOF)

Supplementary Protection Certificates for SAMSCA

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