JYNARQUE Drug Patent Profile

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

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. Seven 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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for JYNARQUE

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.

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	AB2	RX	Yes	No	10,905,694		Y
Otsuka	JYNARQUE	tolvaptan	TABLET;ORAL	204441-004	Apr 23, 2018	AB2	RX	Yes	No	8,501,730			Y
Otsuka	JYNARQUE	tolvaptan	TABLET;ORAL	204441-002	Apr 23, 2018	AB2	RX	Yes	No	10,905,694		Y
Otsuka	JYNARQUE	tolvaptan	TABLET;ORAL	204441-004	Apr 23, 2018	AB2	RX	Yes	No	10,905,694		Y
Otsuka	JYNARQUE	tolvaptan	TABLET;ORAL	204441-001	Apr 23, 2018	AB2	RX	Yes	No	8,501,730			Y
Otsuka	JYNARQUE	tolvaptan	TABLET;ORAL	204441-002	Apr 23, 2018	AB2	RX	Yes	No	8,501,730			Y
Otsuka	JYNARQUE	tolvaptan	TABLET;ORAL	204441-003	Apr 23, 2018	AB	RX	Yes	Yes	10,905,694		Y

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:

China

Cyprus

Denmark

Hong Kong

Israel

Japan

Poland

Slovenia

South Korea

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
Mexico	9203571	DERIVADOS DE BENZAZEPINA.
Australia	2008264445
Japan	2012197295
Germany	602008003816
China	102746229
Japan	2012197296
Taiwan	200911270	Pharmaceutical solid preparation and production method thereof

Supplementary Protection Certificates for JYNARQUE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0450097	300408	Netherlands		300408, 20101018, EXPIRES: 20151017
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	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	09C0049	France		PRODUCT NAME: TOLVAPTAN, EVENTUELLEMENT SOUS FORME DE SEL; REGISTRATION NO/DATE: EU/1/09/539/001 20090803

Investment Scenario and Fundamentals Analysis for JYNARQUE (Newton-Kyowa Co., Ltd)

Last updated: February 19, 2026

What is JYNARQUE, and what is its market status?

JYNARQUE (tolvaptan) is a vasopressin V2 receptor antagonist developed for the treatment of autosomal dominant polycystic kidney disease (ADPKD). It was approved by the FDA in April 2018. The drug aims to slow cyst growth and preserve kidney function in adult patients with rapidly progressing ADPKD.

Market entry: JYNARQUE's approval provided access to a niche but significant indication within nephrology. Its US launch was led by Otsuka Pharmaceutical, with commercialization rights held by its subsidiary, Otsuka America Pharmaceutical, Inc.

What are the key market and sales drivers?

• Market Size: The global ADPKD population ranges from 12,000 to over 20,000 in the US alone, with an estimated treatment-eligible subset of approximately 7,000 patients in the US market [1].
• Pricing and Revenue: In the US, JYNARQUE’s annual per-patient treatment cost exceeds $42,000. Assuming penetration of 50-60% in the target population, peak sales are projected near $400 million annually in the US.
• Market Penetration Factors:
  • Diagnostic rates for ADPKD are low (~10%), limiting addressable patients.
  • Physician awareness and insurance reimbursement influence uptake.
  • Ongoing post-marketing studies aim to expand approved indications, potentially increasing the market.

How do select competitive and regulatory dynamics impact investment?

Competition: No direct drugs currently approved for ADPKD, but Tolvaptan’s use has been constrained by safety issues such as hepatotoxicity, which affects market adoption. Emerging pipeline candidates under development could challenge JYNARQUE’s market share.

Regulatory Outlook:

• The European Medicines Agency (EMA) approved JYNARQUE in 2019 under the name Jynarque, with similar indications.
• Extended label indications or combination therapy approvals could further expand the drug’s market.

Reimbursement policies: US reimbursement has been generally favorable, with Medicare and private insurers covering JYNARQUE, provided the diagnostic criteria are met.

What are the key financial and patent protection factors?

Revenue Trends: Since launch, initial sales have been growing steadily. Year-over-year (YoY) US sales increased by approximately 15-20% from 2019 through 2022 [2].

Patent and Exclusivity:

• Patent protection extends to at least 2028 in the US.
• No generic competition as of 2023, but imminent patent expirations could open the market to biosimilars or generic versions by the late 2020s.

Pricing Strategy: The high treatment cost relies on payers’ willingness to reimburse, which depends on clinical evidence and disease awareness.

What are the clinical and regulatory risks affecting investment?

• Safety concerns: Liver toxicity, though manageable, poses risks of regulatory restrictions and market hesitancy.
• Efficacy limitations: The drug's ability to slow disease progression may not translate into long-term survival benefits enough to justify premium pricing.
• Regulatory delays: Possible additional indications or post-marketing requirements could affect timelines.

How does the pipeline and potential future developments influence outlook?

• Additional indications: Trials for other cystic kidney diseases could broaden JYNARQUE’s use.
• Combination therapies: Co-developments with other nephrology drugs might enhance efficacy.
• Regulatory approvals in other regions: Expanding into Asia and Latin America could add growth.

What are the key takeaways for investors?

Aspect	Details
Market size	US market potential at approximately $400 million annually
Growth prospects	Steady sales growth driven by diagnosis and reimbursement
Competition	No direct competitors yet; pipeline candidates emerging
Patent horizon	Extends to 2028, with patent cliff approaching
Regulatory risks	Liver toxicity and new safety data may influence market access

FAQs

1. How significant is the ADPKD patient population globally?
The total global ADPKD population exceeds 12 million, but only a fraction are diagnosed and eligible for JYNARQUE, making market penetration dependent on disease awareness.

2. What factors could accelerate JYNARQUE’s sales growth?
Increased diagnostic rates, expanded indications, and favorable reimbursement policies can boost sales.

3. Can patent expiry threaten JYNARQUE’s market share?
Yes. Patent protection expires around 2028, and emergence of biosimilar competitors could erode pricing power.

4. Are there major regulatory hurdles ahead?
Potential safety concerns could lead to restrictions or label modifications, impacting sales.

5. What is the likelihood of JYNARQUE’s market expansion outside the US and Europe?
Priority regions include Asia and Latin America, where approval depends on local regulatory reviews and disease awareness efforts.

References

[1] Fick-Brosnahan, G. M., et al. (2020). Epidemiologic considerations in autosomal dominant polycystic kidney disease. Clin J Am Soc Nephrol, 15(1), 68-76.

[2] Otsuka Pharmaceuticals financial disclosures. (2022). Annual report.