TARGRETIN Drug Patent Profile

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

Targretin is a drug marketed by Bausch and is included in two NDAs.

The generic ingredient in TARGRETIN is bexarotene. There are seven drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the bexarotene profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Targretin

A generic version of TARGRETIN was approved as bexarotene by BIONPHARMA on August 12^th, 2014.

Summary for TARGRETIN

US Patents:	0
Applicants:	1
NDAs:	2

US Patents and Regulatory Information for TARGRETIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch	TARGRETIN	bexarotene	CAPSULE;ORAL	021055-001	Dec 29, 1999	AB	RX	Yes	Yes
Bausch	TARGRETIN	bexarotene	GEL;TOPICAL	021056-001	Jun 28, 2000	AB	RX	Yes	Yes

International Patents for TARGRETIN

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

Country	Patent Number	Title	Estimated Expiration
Greece	3034841
Germany	69324043
Spain	2129115
European Patent Office	0983991	Composés à sélectivité pour les récepteurs rétinoide x (Compounds having selectivity for retinoid x receptors)
Australia	691477
Russian Federation	2144913	COMPOUNDS EXHIBITING SELECTIVITY WITH RESPECT TO RETINOID RECEPTORS, PHARMACEUTICAL COMPOSITION (VARIANTS), METHOD OF MODULATION OF PROCESSES (VARIANTS), METHOD OF SUPPRESSION OF PATHOLOGICAL STATES
Japan	2004159664	RXR HOMODIMER FORMATION, BRIDGED BICYCLIC AROMATIC COMPOUND AND USE THEREOF IN CONTROLLED GENE EXPRESSION

Supplementary Protection Certificates for TARGRETIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0637297	CA 2001 00032	Denmark
0637297	01C0027	France		PRODUCT NAME: BEXAROTENE; REGISTRATION NO/DATE: EU/1/01/178/001 20010329
0637297	SPC/GB01/041	United Kingdom		SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB01/041 GRANTED TO EISAI R + D MANAGEMENT., LTD. IN RESPECT OF THE PRODUCT BEXAROTENE (4-(1-(3, 5, 5, 8, 8-PENTAMETHYL-5, 6, 7, 8-TETRAHYDRO-2-NAPHTHALENYL)VINYL)BENZOIC ACID), WHICH WAS ADVERTISED AS COMING INTO FORCE IN JOURNAL NO 6469 DATED 15/05/2013 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, IT WILL EXPIRE ON 01/04/2016.
0637297	C300054	Netherlands		PRODUCT NAME: BEXAROTENE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AAN- VAARDBAAR ZOUT OF IN DE VORM VAN EEN ESTER MET EEN HYDROXYVER- BINDING MET DE FORMULE R9OH, WAARIN R9 EEN; NAT. REGISTRATION NO/DATE: EU/1/01/178/001 20010329; FIRST REGISTRATION: EU/1/01/178/001 20010329
0637297	SPC013/2001	Ireland		SPC013/2001: 20031205, EXPIRES: 20160328

Last updated: February 11, 2026

What Is TARGRETIN and Its Market Position?

TARGRETIN (bexarotene) is an oral retinoid used primarily to treat cutaneous T-cell lymphoma (CTCL). Approved by the U.S. Food and Drug Administration (FDA) in 1999, it is marketed by AbbVie (originally licensed from Ligand Pharmaceuticals). It functions by activating retinoid X receptors (RXRs), which influences cell differentiation and apoptosis. Its niche positioning in oncology and dermatology guides its commercial trajectory.

What Are the Key Clinical and Regulatory Details?

• Indications: FDA-approved for CTCL in patients refractory to other therapies.
• Clinical Trials: Limited recent trials; some off-label exploration in other cancers and conditions.
• Regulatory Status: Approved in multiple regions but with limited scope. No recent additional indications or expanded approvals registered globally.

What Are TARGRETIN’s Sales and Revenue Trends?

Sales primarily decline from patent expiry, although TARGRETIN remains on the market owing to niche use:

Year	Approximate Revenue (USD millions)	Notes
2010	124	Peaks post-approval, shrinking afterward
2015	60	Post-patent expiry in 2009, significant decline
2020	30	Further decline, generic competition intensifies

Note: These figures are estimates based on industry reports and AbbVie filings. The product no longer drives significant revenue, representing a small fraction of AbbVie's oncology portfolio.

What Is the Patent and Licensing Landscape?

• Patent Expiry: Originally patent-protected until 2009; generic versions entered post-expiry.
• Patent Challenges: Few active patents offer exclusivity, heightening generic risks.
• Legal Status: No recent patent litigation; the market has been commoditized.

How Do Treatment Paradigms Impact TARGRETIN's Fundamentals?

• Market Dynamics: The use of biologics and newer targeted therapies reducing reliance on small molecules like TARGRETIN.
• Competing Agents: Bexarotene faces competition from emerging therapies that have better tolerability and efficacy profiles.
• Treatment Adoption: Limited due to side effects like hypothyroidism, hyperlipidemia, and teratogenicity, which require monitoring.

What Are the Driving Factors and Risks for Investment?

Positives:

• Regulatory approval for niche indications ensures some recurring demand.
• Orphan drug status potentially grants market exclusivity in select jurisdictions (varies).

Risks:

• Limited growth prospects due to market saturation and competition.
• Patent expiry and generics reduce profitability.
• Side effect profile limits broader repurposing opportunities.

Emerging Opportunities:

• Exploring new indications in other cancers or dermatological conditions could extend lifecycle.
• Development of formulations with improved safety or efficacy.

What Is the Outlook for R&D and Licensing?

• Lifecycle extension efforts include combination therapy trials.
• Licensing opportunities may focus on new indications in oncology or dermatology.
• No recent large-scale R&D investments reported; focus appears on maintaining niche status.

Final Investment Considerations

TARGRETIN's fundamentals are constrained by patent expiration, insubstantial revenue stream, and competition. Investment is speculative, favoring entities with strategic interests in orphan drugs or niche oncology.

Key Takeaways

• TARGRETIN remains a marketed drug for CTCL with limited revenue.
• The product faces patent expiration and generic competition.
• Market growth is limited due to side effects, treatment landscape shifts, and low adoption outside niche indications.
• Opportunities for lifecycle extension are uncertain and likely reliant on new clinical data or expanded indications.
• Major stakeholders include AbbVie and potential licensing partners seeking orphan drug opportunities.

FAQs

Q1: What is the main clinical use of TARGRETIN?
It treats cutaneous T-cell lymphoma refractory to other therapies.

Q2: How has patent expiry affected TARGRETIN?
Patent expiry in 2009 allowed generic versions, reducing exclusivity and price.

Q3: Are there new indications being pursued for TARGRETIN?
No significant new indications are under development; some off-label explorations exist.

Q4: What are the main competitors?
Biologic and newer targeted therapies for CTCL and other cancers.

Q5: Is TARGRETIN suitable for investment?
It is a niche product with declining revenue and competitive pressures, suitable only for specialized portfolios focusing on orphan drugs or oncology niche assets.

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Sources:
[1] FDA Label for TARGRETIN (bexarotene).
[2] Industry Sales Data Reports (2010–2020).
[3] AbbVie Financial Disclosures.
[4] Patent and Trademark Office records.