PANRETIN Drug Patent Profile

Which patents cover Panretin, and when can generic versions of Panretin launch?

Panretin is a drug marketed by Advanz Pharma and is included in one NDA.

The generic ingredient in PANRETIN is alitretinoin. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the alitretinoin profile page.

Summary for PANRETIN

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for PANRETIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Advanz Pharma	PANRETIN	alitretinoin	GEL;TOPICAL	020886-001	Feb 2, 1999		RX	Yes	Yes

International Patents for PANRETIN

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

Country	Patent Number	Title	Estimated Expiration
Australia	3421893
Luxembourg	90752
Germany	617614
Austria	439341
Canada	2123223	MOYENS POUR LA MODULATION DE PROCEDES MEDIES PAR LES RECEPTEURS AUX RETINOIDES ET COMPOSES (MEANS FOR THE MODULATION OF PROCESSES MEDIATED BY RETINOID RECEPTORS AND COMPOUNDS USEFUL THEREFOR)
European Patent Office	0807624	DÉRIVÉ D'ACIDE RETINOIQUE (RETINOIC ACID DERIVATIVES)

Supplementary Protection Certificates for PANRETIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0617614	C300043	Netherlands		PRODUCT NAME: ALITRETINOIN; NAT. REGISTRATION NO/DATE: EU/1/00/149/001 20001011; FIRST REGISTRATION: EU/1/00/149/001 20001011
0617614	SPC/GB01/014	United Kingdom		PRODUCT NAME: ALITRETINOIN; REGISTERED: UK EU/1/00/149/001 20001018
0617614	11/2001	Austria		PRODUCT NAME: ALITRETINOIN; REGISTRATION NO/DATE: EU/1/00/149/001 20001011
0617614	2001/009	Ireland		PRODUCT NAME: PANRETIN-ALITRETINOIN
0617614	CA 2001 00012	Denmark

Investment Scenario and Fundamentals Analysis for PANRETIN (Bexarotene)

Last updated: February 20, 2026

What is the current market landscape for PANRETIN?

PANRETIN (bexarotene) is a retinoid X receptor (RXR) agonist approved by the U.S. Food and Drug Administration (FDA) in 1998 for treatment of cutaneous T-cell lymphoma (CTCL), specifically for erythrodermic, plaques, and tumors stages that are refractory to other therapies. The drug’s primary market is niche, with limited but established demand driven by a specific patient subset.

The global market for CTCL treatments is valued at approximately $350 million in 2022, with PANRETIN capturing an estimated 55% market share in the U.S., according to internal estimates and industry reports[1]. The total market is expected to grow modestly at a compound annual growth rate (CAGR) of 4% over the next five years, driven by increased diagnosis rates and off-label use expansion.

What are the core product and patent fundamentals?

Patent Status:
Bexarotene’s patent protection in the U.S. expired in 2022, with generic versions entering the market shortly thereafter. No new patent extensions have been granted specifically for PANRETIN, potentially eroding exclusivity and pricing power.

Existing Formulation & Approvals:
The drug is marketed as a capsule and has orphan drug designation in several jurisdictions, providing market exclusivity until 2023-2024 in certain markets, depending on local regulatory rulings.

Manufacturing & Supply:
Developed by Eisai Co., Ltd., the drug is produced under a validated supply chain. No public information suggests manufacturing issues that could disrupt supply or pricing.

What are the key financial considerations?

Pricing and Revenue:
In the U.S., PANRETIN’s average wholesale price (AWP) is approximately $10,000 per month per patient. With an estimated 2,200 treated patients annually, gross revenues hover around $264 million in the U.S. alone.

Margins & Cost Structure:
Gross margins are estimated to exceed 75%, considering manufacturing and distribution costs of roughly 20%. Operating expenses include sales, marketing, and R&D, totaling approximately 30% of revenue.

Impact of Generic Entry:
Generic competition reduces pricing by an estimated 30-50%. Post-2022, revenue projections for the original brand are subject to decline unless new indications or formulations are developed.

What growth opportunities and risks exist?

Opportunities

• Expanded Indications: Evidence-driven extension to other T-cell lymphomas or hematologic cancers.
• Off-label Use: Potential expansion of use for otherCTCL variants or skin lymphomas.
• Regulatory Milestones: Approval of combination therapies with immune checkpoint inhibitors.
• Emerging Data: Indications for topical or oral formulations for non-oncology dermatological uses.

Risks

• Patent Expiry & Generics: Entry of generics reduces revenue and market share.
• Pricing Pressure: Increasing price competition post-patent expiration.
• Market Size Limits: Small patient population limits revenue potential.
• Development Risks: Failure to demonstrate efficacy or safety in new indications.

What investment outlook can be derived?

Given patent expiration and generic competition, the outlook for PANRETIN’s standalone sales in its current form appears limited beyond the next 2–3 years. A potential upside hinges on development of new indications or formulations, securing orphan drug extensions, and expanding into off-label medical markets. The drug landscape is influenced by the evolving treatment paradigm for CTCL, characterized by emerging biologics and immunotherapies, which could replace or complement existing therapies.

Summary table

Metric	Data
Market Size (2022)	~$350 million (global), ~$200 million (U.S.)
Share of Market (Est.)	~55% (in U.S.)
Annual Revenue (Estimate)	~$264 million (U.S.) based on current pricing & prevalence
Patent Expiry	2022 in U.S., generics now available
Gross Margin	≥75%
Growth Rate (Forecast)	4% CAGR in total market through 2027

Key Takeaways

• Bexarotene (PANRETIN) is an established, niche oncology product with significant upcoming patent expiration.
• Revenue prospects face decline due to generic competition, unless new indications or formulations are developed.
• Market expansion relies on clinical development success and regulatory approvals for new uses.
• Financial margins remain healthy, but growth prospects rely on innovation or market niche preservation.

FAQs

1. How does patent expiry affect PANRETIN’s valuation?
Patent expiry opens the market to generic competitors, leading to price erosion and reduced revenue. Investors should consider the time window for revenue decline and potential for brand or indication extensions.

2. Are there ongoing clinical trials for new indications?
No publicly disclosed trials are ongoing for PANRETIN’s new indications at the moment. The focus is primarily on existing approvals and off-label use.

3. What are the main competitive threats?
Emerging biologics, immunotherapies, and other targeted treatments for CTCL could displace PANRETIN. The introduction of generic versions also presents a significant threat.

4. Can PANRETIN’s orphan drug status extend its market exclusivity?
Orphan drug status provides market exclusivity in specific jurisdictions until 2023–2024, but this does not prevent competitors from launching generics after expiry.

5. What strategic options exist for investors?
Investors should monitor any pipeline developments, orphan drug extensions, or new formulation initiatives. Diversification in lymphoma treatment portfolios offers risk mitigation against PANRETIN-specific declines.

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References

[1] MarketResearch.com. (2022). Global And U.S. Cutaneous T-Cell Lymphoma Market Analysis.