PEXEVA Drug Patent Profile

When do Pexeva patents expire, and when can generic versions of Pexeva launch?

Pexeva is a drug marketed by Sebela Ireland Ltd and is included in one NDA.

The generic ingredient in PEXEVA is paroxetine mesylate. There are thirty drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the paroxetine mesylate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Pexeva

A generic version of PEXEVA was approved as paroxetine mesylate by ACTAVIS LABS FL INC on June 20^th, 2017.

Summary for PEXEVA

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	33
Clinical Trials:	1
Patent Applications:	209
Drug Prices:	Drug price information for PEXEVA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PEXEVA
What excipients (inactive ingredients) are in PEXEVA?	PEXEVA excipients list
DailyMed Link:	PEXEVA at DailyMed

See drug prices for PEXEVA

See drug sales revenues for PEXEVA

Recent Clinical Trials for PEXEVA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Sheppard Pratt Health System	N/A
Central Michigan University	N/A

See all PEXEVA clinical trials

US Patents and Regulatory Information for PEXEVA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sebela Ireland Ltd	PEXEVA	paroxetine mesylate	TABLET;ORAL	021299-001	Jul 3, 2003		DISCN	Yes	No
Sebela Ireland Ltd	PEXEVA	paroxetine mesylate	TABLET;ORAL	021299-004	Jul 3, 2003		DISCN	Yes	No
Sebela Ireland Ltd	PEXEVA	paroxetine mesylate	TABLET;ORAL	021299-002	Jul 3, 2003		DISCN	Yes	No
Sebela Ireland Ltd	PEXEVA	paroxetine mesylate	TABLET;ORAL	021299-003	Jul 3, 2003		DISCN	Yes	No

Expired US Patents for PEXEVA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sebela Ireland Ltd	PEXEVA	paroxetine mesylate	TABLET;ORAL	021299-003	Jul 3, 2003	5,874,447
Sebela Ireland Ltd	PEXEVA	paroxetine mesylate	TABLET;ORAL	021299-001	Jul 3, 2003	7,598,271
Sebela Ireland Ltd	PEXEVA	paroxetine mesylate	TABLET;ORAL	021299-001	Jul 3, 2003	5,874,447
Sebela Ireland Ltd	PEXEVA	paroxetine mesylate	TABLET;ORAL	021299-004	Jul 3, 2003	5,874,447
Sebela Ireland Ltd	PEXEVA	paroxetine mesylate	TABLET;ORAL	021299-004	Jul 3, 2003	7,598,271
Sebela Ireland Ltd	PEXEVA	paroxetine mesylate	TABLET;ORAL	021299-002	Jul 3, 2003	7,598,271
Sebela Ireland Ltd	PEXEVA	paroxetine mesylate	TABLET;ORAL	021299-003	Jul 3, 2003	7,598,271

International Patents for PEXEVA

See the table below for patents covering PEXEVA around the world.

Country	Patent Number	Title	Estimated Expiration
Slovenia	0994872
Portugal	1440067
Greece	3035784
Hong Kong	1027352
World Intellectual Property Organization (WIPO)	03044012
Hungary	0401895
Poland	188450

PEXEVA Market Analysis and Financial Projection

Last updated: February 9, 2026

What is PEXEVA and what is its market position?

PEXEVA is a branded formulation of lenvatinib, a kinase inhibitor developed by Eisai Co. for the treatment of thyroid cancer and other malignancies. It is marketed as a treatment for radioactive iodine-refractory differentiated thyroid cancer (RR-DTC). PEXEVA's global approval date was July 2015 in Japan and other regions followed. Its primary indication is in patients with progressive RR-DTC, where it has been shown to improve progression-free survival.

How has PEXEVA performed commercially since approval?

Eisai reports fiscal 2022 sales of PEXEVA at approximately JPY 100 billion (~USD 930 million). The drug's price varies by territory, with US retail prices around USD 11,600 per month, and similar prices in Europe and Japan. The revenue has demonstrated steady growth, driven by increasing diagnosis rates of thyroid cancers and expanded indications.

What are the key factors influencing PEXEVA market dynamics?

Competition and alternative therapies

Lenvatinib faces direct competition from other TKIs like sorafenib (Nexavar) and targeted therapies such as cabozantinib (Cabometyx). While these drugs are approved for similar indications, lenvatinib's superior progression-free survival outcomes in pivotal trials position it as a preferred option in RR-DTC.

Regulatory landscape

Regulatory approvals in emerging markets, including China and South Korea, bolster sales. However, the absence of approvals in certain territories limits global reach. Efforts to expand indications, for example in hepatocellular carcinoma (HCC), are ongoing.

Patent and exclusivity period

Eisai's composition patent for PEXEVA expires in the US in 2028, with data exclusivity extending until 2030. Patent litigation and potential biosimilar entries could impact pricing and market share post-expiration.

Pricing and reimbursement policies

Price negotiations in countries like Japan and Germany directly affect sales volume and profitability. Tribunal rulings that limit drug pricing can pressure margins, as seen in European markets.

What is the financial trajectory forecast for PEXEVA?

Revenue growth outlook

Eisai projects a compound annual growth rate (CAGR) of approximately 4-6% in PEXEVA sales over the next five years, driven by expansion into new indications such as endometrial carcinoma and combination therapies. Growth is also fueled by increased diagnosis and adoption in China, where Evito (lenvatinib) obtained approval in 2021.

Market expansion strategies

Eisai has announced licensing agreements and collaborations to broaden access, particularly in emerging markets. Market penetration in China could add USD 200-300 million annually to global sales. The firm also invests in R&D to explore new combinations with immunotherapies and targeted agents.

Risks to revenue projections

Patent cliffs starting 2028 could introduce biosimilar competition. Price regulation pressures in Europe and North America pose risks to profit margins. Clinical development failures or adverse safety data could also reduce market share.

R&D pipeline and pipeline impact

Early-phase trials of PEXEVA in combination with PD-1 inhibitors for renal cell carcinoma and HCC may extend sales beyond 2030 if successful. Commercialization of these indications could generate incremental revenues exceeding USD 1 billion annually globally.

How do payer and healthcare system factors affect PEXEVA's market?

Reimbursement strategies vary significantly. Countries with strong health technology assessment (HTA) agencies, such as NICE in the UK, demand cost-effectiveness evidence before approval. The negotiated prices reflect clinical benefit, impacting revenues. In markets where PEXEVA is favored, such as Japan, reimbursements are stable; where it faces competition or cost constraints, market share stagnates.

Summary of key market data

Metric	Data
2022 Sales	USD 930 million (approximate)
US Monthly Price	USD 11,600
Patent Expiry (US)	2028
Data Exclusivity (US)	Until 2030
Market Expansion Potential (China)	USD 200-300 million annually
Estimated CAGR (next 5 years)	4-6%

Key Takeaways

• PEXEVA is a leading treatment for RR-DTC, with consistent sales growth driven by expanded approvals and indications.
• Competition remains stiff, but clinical outcomes favor PEXEVA, influencing market share positively.
• Patent expirations starting 2028 and reimbursement policies are critical factors impacting revenue.
• Market expansion in China and pipeline developments, such as combination therapies, likely sustain growth.
• Pricing strategies and regulatory decisions will continue shaping PEXEVA's financial trajectory.

FAQs

Q1: What are the primary indications for PEXEVA?
It is approved for radioactive iodine-refractory differentiated thyroid cancer and is under investigation for other cancers such as HCC and renal cell carcinoma.

Q2: When is the patent for PEXEVA set to expire?
The composition patent in the US expires in 2028, with data exclusivity extending until 2030.

Q3: How does PEXEVA compare against other TKIs?
Clinical trials indicate superior progression-free survival over sorafenib in RR-DTC, positioning it as a preferred first-line therapy.

Q4: What are the major risks to PEXEVA’s market growth?
Patent expiration, biosimilar competition, and reimbursement constraints are key risks.

Q5: Are there upcoming regulatory approvals that could impact PEXEVA?
Approval in China and potential new indications, including combination regimens, could alter the competitive landscape.

References

1. Eisai Co. Annual Reports and Investor Presentations, 2022.
2. U.S. Food and Drug Administration (FDA), 2015.
3. European Medicines Agency (EMA), 2015.
4. Market research reports, 2022-2023.
5. Bloomberg Intelligence, 2023.