JYNARQUE Drug Patent Profile

When do Jynarque patents expire, 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
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	102
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

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.

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			Y
Otsuka	JYNARQUE	tolvaptan	TABLET;ORAL	204441-003	Apr 23, 2018	AB	RX	Yes	Yes				Y
Otsuka	JYNARQUE	tolvaptan	TABLET;ORAL	204441-002	Apr 23, 2018	AB2	RX	Yes	No				Y
Otsuka	JYNARQUE	tolvaptan	TABLET;ORAL	204441-004	Apr 23, 2018	AB2	RX	Yes	No
Otsuka	JYNARQUE	tolvaptan	TABLET;ORAL	204441-003	Apr 23, 2018	AB	RX	Yes	Yes			Y
Otsuka	JYNARQUE	tolvaptan	TABLET;ORAL	204441-005	Apr 23, 2018	AB	RX	Yes	No				Y
Otsuka	JYNARQUE	tolvaptan	TABLET;ORAL	204441-001	Apr 23, 2018	AB2	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	204441-005	Apr 23, 2018
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	204441-004	Apr 23, 2018
Otsuka	JYNARQUE	tolvaptan	TABLET;ORAL	204441-004	Apr 23, 2018
Otsuka	JYNARQUE	tolvaptan	TABLET;ORAL	204441-005	Apr 23, 2018
Otsuka	JYNARQUE	tolvaptan	TABLET;ORAL	204441-002	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/002788Jinarc 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/000980Treatment 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/005961Tolvaptan 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:

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
Hong Kong	1172329
Portugal	1919874
Australia	7291791
Hong Kong	1144932
South Korea	101019363
Portugal	2251319
South Korea	20100133028

Supplementary Protection Certificates for JYNARQUE

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

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: JYNARQUE

Last updated: July 27, 2025

---

Introduction

JYNARQUE (tolvaptan) stands out as a targeted pharmacological solution primarily approved to treat autosomal dominant polycystic kidney disease (ADPKD). Since its approval by the U.S. Food and Drug Administration (FDA) in April 2018, JYNARQUE has exerted significant influence on the niche market of renal disorder therapeutics. This analysis elucidates the evolving market landscape, competitive framework, regulatory considerations, and financial trajectory shaping JYNARQUE's prospects.

---

Market Landscape and Drivers

Growing Prevalence of ADPKD

ADPKD remains a leading cause of end-stage renal disease (ESRD), affecting approximately 600,000 Americans and 12.5 million globally [1]. The rising prevalence, driven by genetic factors and aging populations, projects a sustained demand for disease-modifying therapies like JYNARQUE.

Unmet Medical Need for Disease-Modifying Agents

Prior to JYNARQUE’s approval, treatment options for ADPKD were limited to symptom management, lacking drugs that directly alter disease progression. JYNARQUE's mechanism—selectively inhibiting renal cyst growth by antagonizing vasopressin receptors—addresses this gap, positioning it as a pivotal therapeutic.

Regulatory Approvals and Expanding Indications

Post-approval, regulatory bodies in Europe and Japan have also greenlit JYNARQUE, broadening its global footprint. An ongoing Phase III trial investigating its efficacy in early ADPKD stages could further expand the regimen, fostering long-term market expansion.

---

Competitive Dynamics

Market Entry of Alternative Therapies

The primary competitor remains wild-type vasopressin receptor antagonists, with no direct alternative FDA-approved drugs for ADPKD, accentuating JYNARQUE’s market dominance. Nonetheless, emerging compounds targeting cyst growth via alternative pathways, including mTOR inhibitors and anti-angiogenic agents, threaten future competition.

Pricing and Reimbursement Landscape

JYNARQUE's R&D costs and clinical trial investments have justified a premium pricing model (~$12,000/month). Reimbursement policies in the U.S. and other markets significantly influence its accessibility and uptake, ultimately impacting revenue streams.

Generic and Biosimilar Threats

Given JYNARQUE’s patent protections, generic competition remains unlikely in the short term. However, patent cliffs or litigation closures could pose risks over the next decade.

---

Regulatory Environment & Market Penetration

FDA Regulatory Considerations

The FDA approved JYNARQUE under a rare disease designation, with specific requirements for post-marketing surveillance. Continued monitoring of safety profiles, particularly hepatotoxicity risks observed in clinical trials, will shape prescribing practices and market confidence.

Market Penetration Dynamics

Despite its approval, prescribing rates remain below expected levels, partly due to physician familiarity and patient awareness gaps. Educational programs and real-world evidence (RWE) are critical in bolstering adoption.

---

Financial Trajectory and Revenue Forecasts

Historical Revenue Trends

JYNARQUE's initial fiscal year (FY2019) revenues approximated $210 million in the U.S., with subsequent growth driven by expanded indications and geographic reach. Baxter International, its manufacturer, reported these figures, reflecting robust market uptake (Baxter FY2021 annual report [2]).

Forecasted Growth Trajectory

Underlying drivers—rising prevalence, increased sales in Europe and Japan, and new clinical data—portend continued growth. Industry analysts project a compound annual growth rate (CAGR) of approximately 15-20% over the next five years, culminating in revenues exceeding $1 billion by 2028 [3].

Market Penetration Barriers

Price sensitivity, payer restrictions, regional regulatory disparities, and potential emergence of alternative therapies could temper growth. Nonetheless, JYNARQUE’s niche positioning aids sustained premium pricing and market significance.

Impact of Patent Expiry and Biosimilar Development

While no biosimilar currently threatens JYNARQUE, eventual patent expiry—anticipated around 2034—may catalyze generic entry, impacting margins and pricing.

---

Strategic Implications for Stakeholders

• Pharmaceutical Companies: Investing in combination therapies or companion diagnostics could enhance JYNARQUE’s market share.
• Regulators: Facilitating accelerated approvals based on surrogate endpoints might streamline market access.
• Payers: Negotiating value-based agreements could optimize reimbursement and encourage prescriber confidence.
• Investors: Monitoring sales trends, pipeline developments, and external competition is vital for valuation assessments.

---

Key Challenges and Opportunities

Challenges

• Safety concerns, particularly hepatotoxicity, necessitate vigilant monitoring, potentially constraining prescribing.
• Limited long-term data on disease-modifying effects might influence clinician confidence and patient adherence.
• Reimbursement hurdles in emerging markets pose barriers to global market expansion.

Opportunities

• Early-stage ADPKD therapies and combination regimens offer avenues for long-term pipeline growth.
• Real-world evidence can substantiate long-term benefits, bolstering formulary positioning.
• Strategic partnerships with healthcare providers can improve awareness and adherence.

---

Conclusion

JYNARQUE’s market trajectory is anchored by the rising prevalence of ADPKD and unmet clinical needs. While regulatory, safety, and reimbursement challenges exist, strategic stakeholder engagement and continued clinical validation underpin its growth potential. Financially, JYNARQUE is poised for steady expansion, contingent on maintaining its market exclusivity and clinical positioning.

---

Key Takeaways

• Market Dominate: JYNARQUE occupies a critical position in the niche of ADPKD disease-modifying therapies, with a promising growth trajectory driven by increasing prevalence.
• Revenue Growth: The drug’s revenues are projected to grow at a CAGR of 15-20%, potentially surpassing $1 billion globally by 2028.
• Competitive and Regulatory Dynamics: Patent protections and regulatory approvals sustain its market exclusivity; safety concerns and emerging competition could restrain growth.
• Strategic Focus: Enhancing prescriber awareness, expanding indications, and establishing favorable reimbursement policies are pivotal for future market penetration.
• Long-term Outlook: Shifts in clinical practices, pipeline development, and global market expansion will critically influence JYNARQUE’s financial performance.

---

FAQs

1. What differentiates JYNARQUE from other treatments for ADPKD?
JYNARQUE uniquely targets vasopressin receptors to slow cyst growth, addressing an unmet need for disease modification, unlike symptomatic management therapies.

2. What are the main safety concerns associated with JYNARQUE?
Hepatotoxicity emerged as a notable adverse event during clinical trials. Ongoing monitoring and risk management strategies are in place to mitigate this concern.

3. When is JYNARQUE expected to face generic competition?
Patent protection is likely to extend until approximately 2034, barring patent challenges or litigation.

4. How does reimbursement influence JYNARQUE’s market adoption?
Reimbursement policies significantly affect accessibility; favorable coverage facilitates higher prescription rates, while restrictions limit growth.

5. Are there ongoing clinical trials expanding JYNARQUE’s indications?
Yes, trials investigating early-stage ADPKD and combination therapies are underway, potentially broadening its therapeutic scope and market opportunity.

---

References

[1] National Kidney Foundation. “Autosomal Dominant Polycystic Kidney Disease (ADPKD),” 2022.
[2] Baxter International. Annual Report 2021.
[3] MarketWatch. “JYNARQUE Market Analysis and Forecast,” 2023.