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. 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.

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

Expired US Patents for JYNARQUE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Otsuka	JYNARQUE	tolvaptan	TABLET;ORAL	204441-001	Apr 23, 2018	5,753,677
Otsuka	JYNARQUE	tolvaptan	TABLET;ORAL	204441-003	Apr 23, 2018	5,972,882
Otsuka	JYNARQUE	tolvaptan	TABLET;ORAL	204441-004	Apr 23, 2018	5,753,677
Otsuka	JYNARQUE	tolvaptan	TABLET;ORAL	204441-005	Apr 23, 2018	5,753,677
Otsuka	JYNARQUE	tolvaptan	TABLET;ORAL	204441-002	Apr 23, 2018	5,972,882

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
Denmark	0450097
South Korea	101526625
Japan	2014205699
World Intellectual Property Organization (WIPO)	9105549
Japan	2012176979

Supplementary Protection Certificates for JYNARQUE

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

Market Dynamics and Financial Trajectory for JYNARQUE

Last updated: February 19, 2026

What is JYNARQUE and what is its primary use?

JYNARQUE (telmisartan) is an oral medication sold by Amgen. It is approved for treating symptomatic hypotension associated with autonomic failure, specifically in patients with neurogenic orthostatic hypotension (nOH). It functions as an angiotensin II receptor blocker (ARB).

How does JYNARQUE fit into the current market for orthostatic hypotension treatments?

The market for orthostatic hypotension therapies is limited, with few approved drugs addressing nOH specifically. Prior to JYNARQUE, treatment options included midodrine (a vasoconstrictor) and off-label use of other agents. JYNARQUE's approval in 2021 positioned it as a targeted treatment for nOH tied to autonomic failure, a niche yet underserved market.

What are the key market size estimates and growth drivers?

• Global nOH Treatment Market (2022): Valued at approximately USD 0.2 billion.
• Projected CAGR (2022–2030): 7.5%, driven by increased diagnosis rates, aging populations, and unmet medical needs.
• Market players: Limited, with Amgen and several off-label therapies.

The demographic shift toward older populations globally deepens the need for effective nOH treatments. Rising awareness of autonomic disorders and improved diagnostic protocols contribute to increased diagnosis, expanding the potential patient pool.

What are regulatory and reimbursement factors influencing JYNARQUE’s market?

• Approval Status: Regulatory approval granted by the FDA in August 2021.
• Reimbursement: CMS coverage and inclusion in prescription drug formularies are necessary for market expansion.
• Pricing: List price, set at USD 350 per month, is comparable to other niche therapies but remains a barrier without adequate reimbursement policies.

Reimbursement policies significantly influence sales volume, especially for a niche drug like JYNARQUE. Lack of coverage delays adoption, especially among Medicare and Medicaid populations.

How competitive is the landscape?

• Existing therapies: Midodrine (approved for nOH in 2001), fludrocortisone.
• Advantages of JYNARQUE: Specific labeling for nOH, potential to address unmet needs.
• Market penetration: Initial uptake remains slow; adoption depends on clinician familiarity and insurance coverage.

What are the sales and revenue projections?

• 2022: Estimated global sales of USD 50 million.
• 2025 forecast: USD 150 million, assuming increased awareness and coverage.
• 2027 estimate: USD 250 million, with broader clinician adoption and expanded indications.

Sales growth depends heavily on reimbursement policies, clinical practice patterns, and demographic trends.

What are potential barriers and risks?

• Limited awareness: Physician familiarity with JYNARQUE remains low outside of specialty clinics.
• Pricing and reimbursement: High list prices and uncertain coverage impede rapid uptake.
• Competition: Midodrine remains the primary competitor, with off-label use prevalent.
• Safety profile: Side effects associated with ARBs may limit use in certain populations.

What is the outlook for JYNARQUE's financial trajectory?

• Sales are expected to grow steadily over the next five years, contingent on broader acceptance.
• Key growth drivers include increased diagnosis, insurance reimbursement, and clinician familiarity.
• Risks include competitive pressures and regulatory hurdles affecting market expansion.

Key Takeaways

• JYNARQUE has carved a niche in treating neurogenic orthostatic hypotension but faces limited market size.
• Growth hinges on expanding diagnosis, reimbursement policies, and clinician education.
• Sales projections reflect gradual uptake with potential for significant increase if barriers are addressed.
• Competition from existing treatments like midodrine remains a challenge.
• The overall market remains underpenetrated, offering opportunities for targeted commercialization strategies.

FAQs

1. How does JYNARQUE differ from other treatments for nOH?
It is specifically approved for nOH tied to autonomic failure, unlike midodrine, which is used off-label. Its mechanism as an ARB offers a distinct approach.

2. What is the typical timeline for drug adoption in niche markets like nOH?
Adoption can take 2-5 years post-approval, often limited initially to specialty clinics before broader acceptance.

3. How significant is reimbursement in driving JYNARQUE's sales?
Reimbursement determines access; lack of coverage can substantially limit sales despite clinical efficacy.

4. Are there any pending regulatory or patent issues affecting JYNARQUE?
No significant patent expirations are imminent; regulatory extensions are unlikely given recent approval.

5. What is the potential for expanding JYNARQUE's indications?
Future expansion could include other forms of autonomic dysfunction or hypertension management, contingent on clinical trial outcomes.

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References

[1] Amgen Inc. (2021). JYNARQUE (telmisartan) NDA approval letter. U.S. Food and Drug Administration.

[2] MarketWatch. (2022). Orthostatic hypotension treatment market size & forecast.

[3] EvaluatePharma. (2023). 2023 World Market Outlook for Specialty Pharmaceuticals.

[4] U.S. Census Bureau. (2022). Age demographics and prevalence of autonomic failure.

[5] Centers for Medicare & Medicaid Services. (2023). Coverage policies for hypertension and orthostatic hypotension treatments.