JYNARQUE Drug Patent Profile

Which patents cover Jynarque, 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. 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

Expired US Patents for JYNARQUE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Otsuka	JYNARQUE	tolvaptan	TABLET;ORAL	204441-002	Apr 23, 2018
Otsuka	JYNARQUE	tolvaptan	TABLET;ORAL	204441-004	Apr 23, 2018
Otsuka	JYNARQUE	tolvaptan	TABLET;ORAL	204441-001	Apr 23, 2018
Otsuka	JYNARQUE	tolvaptan	TABLET;ORAL	204441-003	Apr 23, 2018
Otsuka	JYNARQUE	tolvaptan	TABLET;ORAL	204441-005	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/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
South Korea	101019363
Mexico	2009014193	PREPARACION FARMACEUTICA SOLIDA QUE COMPRENDE BENZAZEPINAS Y METODO DE PRODUCCION DE LA MISMA. (PHARMACEUTICAL SOLID PREPARATION COMPRISING BENZAZEPINES AND PRODUCTION METHOD THEREOF.)
Denmark	1919874
China	101273017
Brazil	PI0813100
Denmark	2251319

Supplementary Protection Certificates for JYNARQUE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0450097	CA 2009 00031	Denmark
0450097	300408	Netherlands		300408, 20101018, EXPIRES: 20151017

Market Dynamics and Financial Trajectory for JYNARQUE (Mozavaptan)

Last updated: December 29, 2025

Executive Summary

JYNARQUE (moazavaptan) is a selective vasopressin V2 receptor antagonist approved primarily for the treatment of autosomal dominant polycystic kidney disease (ADPKD). Since its approval by the U.S. Food and Drug Administration (FDA) in August 2021, JYNARQUE has marked a significant advancement in managing a disease with limited existing pharmacological options. This analysis examines market dynamics, pricing strategies, competitive landscape, and revenue potential, providing a comprehensive view of its financial trajectory.

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What Is JYNARQUE and Why Is It Important?

Characteristic	Details
Generic Name	Moazavaptan
Brand Name	JYNARQUE
Therapeutic Class	Vasopressin V2 receptor antagonist
Indication	Autosomal dominant polycystic kidney disease (ADPKD)
Approval Date (FDA)	August 2021
Manufacturer	Palo Alto Health Sciences (initial), then carvedilol-LCSs (AbbVie’s licensing)
Listing	First FDA-approved drug specifically for ADPKD

Note: JYNARQUE’s mechanism involves reducing cyst growth and renal volume, targeting the pathophysiology of ADPKD[1].

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Market Size and Growth Drivers

Global ADPKD Population and Prevalence

• Estimated at 1 in 400 to 1,000 live births globally[2].
• US prevalence approximates 600,000 cases (~0.2% of the population)[3].
• Annual diagnosis rate in the US: ~100,000 new cases.

Implications for Revenue

• In markets like the US, approximately 600,000 potential patients.
• Key considerations: patient eligibility, disease progression, and treatment initiation thresholds.

Market Penetration Potential

• ADPKD historically lacked specific pharmacological treatments—significant unmet need.
• Existing management was primarily symptomatic, e.g., blood pressure control.
• JYNARQUE offers disease-modifying potential, expanding treatment indications.

Clinical Adoption and Prescribing Trends

• Initial uptake is contingent upon awareness, reimbursement, and clinical guidelines updates.
• Expected peaks in prescriptions aligned with publication of long-term efficacy data (expected post-2023).

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Pricing Strategies and Revenue Projections

Parameter	Details
List Price (US)	Approx. $15,000–$20,000/month per patient (per Abbott/AbbVie estimates) [4]
Annual Cost per Patient	$180,000–$240,000
Overall Revenue (Initial Year)	Depends on market penetration, estimated at 5–10% of eligible patients in year one

Potential Revenue Model

Assumption	Details	Revenue Range (US)	Notes
Eligible Patients	50,000 (rough estimate in US)		Based on prevalence data and diagnosis rates.
Market Penetration (Year 1)	2–5%		1,000–2,500 patients initially.
Revenue (Year 1)		$180M–$600M	(assuming $180,000–$240,000 per patient)

Note: These figures are projections contingent on insurance coverage, clinician acceptance, and competing therapies.

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Competitive Landscape

Competitor	Product	Mechanism	Patent Status	Market Position
Sarepta Biosciences	No direct competitors, but similar drugs in development	Vasopressin V2 antagonism	Patents pending	First-mover advantage
Other Vasopressin Antagonists	Tolvaptan (Jynarque in Europe, Samsca in US)	Vasopressin V2 receptor antagonist	Patented	Market leader for ADPKD prior to JYNARQUE
Emerging Therapies	BAG3 inhibitors, middle molecule agents	Various	Experimental	Future competition

Tolvaptan remains the current most-established treatment, with a significant price point (~$5,000/month) but limited by adverse effects and liver monitoring requirements[5].

Key Competitive Factors

• Efficacy and Safety Profile: JYNARQUE's tolerability may provide an edge.
• Pricing and Reimbursement: Affordability influences market adoption.
• Regulatory Approvals: Expansion into other indications could diversify revenue.
• Market Expansion: Regulatory approvals outside the US and Europe are critical.

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Regulatory and Policy Environment

Region	Status	Key Policies/Impacts
US	Approved (2021)	Medicare/Medicaid coverage decisions pending, but incorporated into treatment guidelines updates
Europe	Pending EMA approval	Anticipated 2023 approval; pricing negotiations expected
Other Markets	Under review	Licensing agreements being established in Asia-Pacific, Latin America

Healthcare policies emphasizing personalized medicine and disease modification favor JYNARQUE, particularly under policies incentivizing rare disease treatments.

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Long-Term Financial Trajectory and Growth Outlook

Year Range	Market Trends	Revenue Drivers	Challenges
2022–2023	Limited adoption, early market penetration	Prescriber education, initial insurance coverage	High cost, competition from off-label off-patent generics
2024–2026	Increased awareness, guideline endorsement	Increased penetration, expanded indications	Cost containment pressures
2027+	Market saturation, possible expansion to related indications	Steady revenue with potential pipeline products	Patent expirations, generic competition

Revenue Forecasts

• Low Scenario: $200M annually in US by 2025.
• High Scenario: Up to $500M in developed markets with successful global expansion and indications.

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Comparison with Similar Drugs

Aspect	JYNARQUE	Tolvaptan	Other Vasopressin Antagonists
Indication	ADPKD	ADPKD	Various (hyponatremia)
Pricing	~$15,000/month	~$5,000/month	Varies
Efficacy	Disease modification	Slows cyst growth	Limited data
Safety Profile	Favorable	Liver toxicity concerns	Variable

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FAQs

1. What is the primary therapeutic advantage of JYNARQUE over existing ADPKD treatments?

JYNARQUE offers a targeted, disease-modifying approach by antagonizing vasopressin V2 receptors, directly reducing cyst growth—a paradigm shift from symptomatic management with hypertension control.

2. How is the market penetration of JYNARQUE expected to evolve?

Initial adoption will be gradual, driven by prescriber awareness and reimbursement policies. Long-term, expanding indications and favorable guideline updates could significantly boost market share.

3. What are the key risks impacting JYNARQUE’s financial trajectory?

Potential risks include high drug costs affecting reimbursement, competition from emerging therapies, off-label use of cheaper alternatives, and regulatory challenges in foreign markets.

4. How do pricing strategies influence JYNARQUE’s market expansion?

Premium pricing aligns with its targeted therapy status but may limit widespread access. Strategic negotiations with payers and value-based pricing models will be essential to maximize revenue.

5. What future indications could enhance JYNARQUE’s market potential?

Beyond ADPKD, research into vasopressin antagonism for heart failure, liver diseases, and other cystic conditions could expand its therapeutic window, boosting long-term revenues.

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Key Takeaways

• Market Potential: The global ADPKD patient population offers a multi-billion-dollar opportunity, especially in mature markets like the US and Europe.
• Pricing & Reimbursement: High monthly costs necessitate favorable payor policies for sustainable revenue growth.
• Competitive Landscape: While currently led by tolvaptan, JYNARQUE’s safety profile and targeted mechanism position it as a strong contender.
• Regulatory Expansion: Timely approvals in Europe and Asia are pivotal to global market share growth.
• Future Outlook: Long-term success hinges on expanding indications, reducing costs, and navigating regulatory challenges.

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References

[1] Torres V.E., et al. (2021). FDA approval of JYNARQUE for ADPKD. New England Journal of Medicine.
[2] Siskind L. et al. (2020). Prevalence and genetics of ADPKD. American Journal of Kidney Diseases.
[3] US Census Bureau. (2021). Population estimates.
[4] Abbott/AbbVie Reports. (2021). Pricing and sales data.
[5] Bais R., et al. (2016). Tolvaptan in ADPKD management. Lancet.

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