JYNARQUE Drug Patent Profile

When do Jynarque patents expire, and when can generic versions of Jynarque launch?

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

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

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Jynarque

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

Summary for JYNARQUE

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

See drug prices for JYNARQUE

Pharmacology for JYNARQUE

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

Anatomical Therapeutic Chemical (ATC) Classes for JYNARQUE

C03XA	Vasopressin antagonists
C03X	OTHER DIURETICS
C03	DIURETICS
C	Cardiovascular system

Paragraph IV (Patent) Challenges for JYNARQUE

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

US Patents and Regulatory Information for JYNARQUE

JYNARQUE is protected by two US patents and one FDA Regulatory Exclusivity.

Patents protecting JYNARQUE

FDA Regulatory Exclusivity protecting JYNARQUE

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	204441-001	Apr 23, 2018		RX	Yes	No			Y
Otsuka	JYNARQUE	tolvaptan	TABLET;ORAL	204441-003	Apr 23, 2018		RX	Yes	Yes			Y
Otsuka	JYNARQUE	tolvaptan	TABLET;ORAL	204441-002	Apr 23, 2018		RX	Yes	No				Y
Otsuka	JYNARQUE	tolvaptan	TABLET;ORAL	204441-004	Apr 23, 2018		RX	Yes	No
Otsuka	JYNARQUE	tolvaptan	TABLET;ORAL	204441-003	Apr 23, 2018		RX	Yes	Yes				Y
Otsuka	JYNARQUE	tolvaptan	TABLET;ORAL	204441-005	Apr 23, 2018		RX	Yes	No			Y
Otsuka	JYNARQUE	tolvaptan	TABLET;ORAL	204441-001	Apr 23, 2018		RX	Yes	No				Y

Expired US Patents for JYNARQUE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Otsuka	JYNARQUE	tolvaptan	TABLET;ORAL	204441-003	Apr 23, 2018
Otsuka	JYNARQUE	tolvaptan	TABLET;ORAL	204441-001	Apr 23, 2018
Otsuka	JYNARQUE	tolvaptan	TABLET;ORAL	204441-002	Apr 23, 2018
Otsuka	JYNARQUE	tolvaptan	TABLET;ORAL	204441-002	Apr 23, 2018
Otsuka	JYNARQUE	tolvaptan	TABLET;ORAL	204441-005	Apr 23, 2018
Otsuka	JYNARQUE	tolvaptan	TABLET;ORAL	204441-004	Apr 23, 2018
Otsuka	JYNARQUE	tolvaptan	TABLET;ORAL	204441-005	Apr 23, 2018

EU/EMA Drug Approvals for JYNARQUE

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 JYNARQUE

When does loss-of-exclusivity occur for JYNARQUE?

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 JYNARQUE around the world.

Country	Patent Number	Title	Estimated Expiration
South Korea	20100132087	PROCESS FOR PREPARING BENZAZEPINE COMPOUNDS OR SALTS THEREOF
Hong Kong	1144932	PROCESS FOR PREPARING DERIVATIVES OF BENZOIC ACID
Japan	2012197295	PROCESS FOR PREPARING BENZOAZEPINE COMPOUND OR SALT THEREOF
Portugal	1919874
Hong Kong	1145835	製備苯並氮雜卓化合物或其鹽的方法 (PROCESS FOR PREPARING BENZAZEPINE COMPOUNDS OR SALTS THEREOF)
Israel	217444	תהליך עבור תרכובות בנזאפין או מלחים מזה (Process for preparing benzazepine compounds or salts thereof)
Austria	489944

Supplementary Protection Certificates for JYNARQUE

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