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. Six 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
Patent Applications:	1,174
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		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

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

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
Spain	2354030
Japan	5046587
Israel	189481	תהליך עבור הפקת תרכובות 2,3,4,5-טטרההידרו-h1-1-בנזאזפין או מלחים מזה ותרכובת נקייה מאוד המופקת על ידי תהליך האמור (Process for producing 2,3,4,5-tetrahydro-1h-1- benzazepine compounds or salts thereof and highly pure compounds produced by said process)

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	C300408	Netherlands		PRODUCT NAME: TOLVAPTAN, DESGEWENST IN DE VORM VAN EEN ZOUT; REGISTRATION NO/DATE: EU/1/09/539/001-004 20090803
0450097	CA 2009 00031	Denmark

JYNARQUE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for JYNARQUE

Introduction

JYNARQUE, also known as tolvaptan, is a V2 receptor antagonist developed by Otsuka Pharmaceuticals for the treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD). Here, we delve into the market dynamics and financial trajectory of this drug, highlighting its current status, future projections, and the challenges it faces.

Market Position and Exclusivity

JYNARQUE holds a unique position in the ADPKD treatment market as the only approved drug for this indication. This early mover advantage, combined with its Orphan Drug Exclusivity, has restricted the entry of generics, making JYNARQUE the dominant player in the PKD drugs market[1].

Sales Performance

The sales of JYNARQUE have been robust, driven by increasing disease prevalence and rising awareness. In the fiscal year 2022, sales of JINARC/JYNARQUE totaled ¥139,409 million, representing a significant increase of 38.9% compared to the previous year[5].

Revenue Growth

Otsuka's pharmaceutical business, which includes JYNARQUE, has seen steady growth. For the six-month period ended June 30, 2022, the pharmaceutical segment recorded revenue of ¥529,294 million, contributing substantially to the company's overall revenue growth of 13.3% over the same period of the previous fiscal year[2].

Clinical and Market Impact

JYNARQUE's effectiveness in slowing cyst formation and delaying the progression of ADPKD has been a key factor in its market success. The drug is available through a restricted distribution program, the JYNARQUE REMS Program in the US, due to its contraindications and safety concerns, particularly in individuals with cirrhosis and reduced liver function[1].

Disease Awareness and Promotion

Efforts to raise disease awareness and make clinical trial data available have significantly contributed to the recognition and adoption of JYNARQUE. In the U.S. and Europe, prescriptions for JYNARQUE have increased steadily following its launch and the promotion of proper use guidelines[4].

Competitive Landscape

While JYNARQUE enjoys exclusivity until 2025, Otsuka faces a looming competitive threat from multiple generics expected to launch after its exclusivity expires. Additionally, several pipeline ADPKD therapies are in development, which could further challenge JYNARQUE's market share[1].

Financial Projections

Otsuka's financial reports indicate that JYNARQUE will continue to be a significant revenue driver until its exclusivity ends. According to DelveInsight analysis, JYNARQUE is expected to attain its peak market share by 2025. After this period, the entry of generics and new therapies will likely impact its market dominance[1].

Business Profit and Operating Results

The pharmaceutical business segment, which includes JYNARQUE, has been a major contributor to Otsuka's business profit. For the fiscal year 2022, the business profit from pharmaceuticals was ¥65,023 million, although this figure saw a slight decline due to increased research and development expenses and other factors[2].

Research and Development Expenses

Otsuka has been investing heavily in research and development, which includes further studies on JYNARQUE, such as its effectiveness in pediatric subjects with ADPKD. These investments are crucial for maintaining and expanding the drug's market position but also impact the company's short-term financial performance[3].

Regulatory and Safety Considerations

JYNARQUE carries a black box warning due to its contraindications, particularly in individuals with cirrhosis and reduced liver function. These safety concerns and the need for a restricted distribution program add complexity to its market dynamics and may affect its long-term adoption rates[1].

Global Expansion

JYNARQUE is sold in approximately 20 countries, with increasing prescriptions in regions like Europe and the U.S. This global expansion is part of Otsuka's strategy to maximize the value of its global products, including JYNARQUE, under its Third Medium-Term Management Plan[4].

Future Outlook

Otsuka's strategy to maintain JYNARQUE's market position involves continuous efforts to raise disease awareness, expand its global reach, and invest in further clinical trials. However, the company must also prepare for the competitive challenges that will arise after the drug's exclusivity expires in 2025[1].

Key Takeaways

• Market Dominance: JYNARQUE is the only approved drug for ADPKD, enjoying exclusivity until 2025.
• Revenue Growth: Significant sales growth driven by increasing disease prevalence and awareness.
• Competitive Threats: Expected entry of generics and new therapies post-2025.
• Regulatory Considerations: Black box warning and restricted distribution program due to safety concerns.
• Global Expansion: Sold in approximately 20 countries with increasing prescriptions.
• Future Strategy: Continuous disease awareness efforts, global expansion, and investment in clinical trials.

FAQs

Q: What is JYNARQUE used for?

A: JYNARQUE is used for the treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD).

Q: Why does JYNARQUE have a restricted distribution program?

A: JYNARQUE has a restricted distribution program due to its contraindications, particularly in individuals with cirrhosis and reduced liver function.

Q: What is the current market position of JYNARQUE?

A: JYNARQUE is the only approved drug for ADPKD and holds a dominant position in the market due to its exclusivity until 2025.

Q: How does Otsuka plan to maintain JYNARQUE's market position?

A: Otsuka plans to maintain JYNARQUE's market position through continuous disease awareness efforts, global expansion, and investment in further clinical trials.

Q: What challenges will JYNARQUE face after its exclusivity expires in 2025?

A: After its exclusivity expires in 2025, JYNARQUE will face significant competitive threats from generics and new therapies in the ADPKD treatment market.

Sources

1. DelveInsight: Potential Therapies for ADPKD Treatment | Emerging Therapeutic Landscape.
2. Marketscreener: Otsuka Consolidated Financial Results for the Second Quarter of the Fiscal Year Ending December 31.
3. Otsuka: Integrated Report 2018.
4. Otsuka: Five-Year Growth Phase (2019–2023).
5. Otsuka: Consolidated Financial Results for the Fiscal Year Ended December 31, 2023 (Forecast).