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 three branded drugs marketed by Otsuka, Alkem Labs Ltd, Apotex, Endo Operations, Hetero Labs Ltd V, and MSN, and is included in seven 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 eighty-six patent family members in twenty-four countries.

There are eight drug master file entries for tolvaptan. Six suppliers are listed for this compound.

Summary for tolvaptan

International Patents:	86
US Patents:	2
Tradenames:	3
Applicants:	6
NDAs:	7
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	101
Clinical Trials:	93
Patent Applications:	1,870
Drug Prices:	Drug price trends for tolvaptan
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for tolvaptan
What excipients (inactive ingredients) are in tolvaptan?	tolvaptan excipients list
DailyMed Link:	tolvaptan at DailyMed

See drug prices for tolvaptan

Recent Clinical Trials for tolvaptan

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

Sponsor	Phase
University Medical Center Groningen	Phase 3
University of Colorado, Denver	Phase 2
University of Maryland	Phase 2

See all tolvaptan clinical trials

Pharmacology for tolvaptan

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

Anatomical Therapeutic Chemical (ATC) Classes for tolvaptan

C03XA	Vasopressin antagonists
C03X	OTHER DIURETICS
C03	DIURETICS
C	Cardiovascular system

Paragraph IV (Patent) Challenges for TOLVAPTAN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
JYNARQUE	Tablets	tolvaptan	15 mg, 30 mg, 45 mg, 60 mg, 90 mg	204441	1	2021-04-08
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 tolvaptan

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Otsuka	JYNARQUE	tolvaptan	TABLET;ORAL	204441-005	Apr 23, 2018		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Alkem Labs Ltd	TOLVAPTAN	tolvaptan	TABLET;ORAL	211891-001	May 19, 2020	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Otsuka	JYNARQUE	tolvaptan	TABLET;ORAL	204441-004	Apr 23, 2018		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Otsuka	SAMSCA	tolvaptan	TABLET;ORAL	022275-003	May 19, 2009	⤷ Sign Up	⤷ Sign Up
Otsuka	JYNARQUE	tolvaptan	TABLET;ORAL	204441-003	Apr 23, 2018	⤷ Sign Up	⤷ Sign Up
Otsuka	SAMSCA	tolvaptan	TABLET;ORAL	022275-002	May 19, 2009	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for tolvaptan

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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 tolvaptan

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Country	Patent Number	Title	Estimated Expiration
Israel	222396	תהליך הכנה תרכובת ל 4-(בנזואילאמינו) חומצה בנזואיק או מלחים שלהם (Process for preparing 4-(benzoylamino)benzoic acid compounds or salts thereof)	⤷ Sign Up
European Patent Office	2167046	COMPOSITION PHARMACEUTIQUE SOLIDE CONTENANT DES BENZAZEPINES ET PROCÉDÉ DE PRODUCTION DE CELLE-CI (PHARMACEUTICAL SOLID PREPARATION COMPRISING BENZAZEPINES AND PRODUCTION METHOD THEREOF)	⤷ Sign Up
South Korea	20080039459	PROCESS FOR PREPARING BENZAZEPINE COMPOUNDS OR SALTS THEREOF	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for tolvaptan

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0450097	SPC/GB09/037	United Kingdom	⤷ Sign Up	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	⤷ Sign Up	PRODUCT NAME: TOLVAPTAN, DESGEWENST IN DE VORM VAN EEN ZOUT; REGISTRATION NO/DATE: EU/1/09/539/001-004 20090803
0450097	09C0049	France	⤷ Sign Up	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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