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
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	98
Clinical Trials:	30
Patent Applications:	2,154
Drug Prices:	Drug price information for TARGRETIN
What excipients (inactive ingredients) are in TARGRETIN?	TARGRETIN excipients list
DailyMed Link:	TARGRETIN at DailyMed

See drug prices for TARGRETIN

Recent Clinical Trials for TARGRETIN

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

Sponsor	Phase
National Cancer Centre, Singapore	Phase 1
National Medical Research Council (NMRC), Singapore	Phase 1
The Cleveland Clinic	Phase 2

See all TARGRETIN clinical trials

Pharmacology for TARGRETIN

Drug Class

Retinoid

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

Expired US Patents for TARGRETIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	TARGRETIN	bexarotene	GEL;TOPICAL	021056-001	Jun 28, 2000
Bausch	TARGRETIN	bexarotene	CAPSULE;ORAL	021055-001	Dec 29, 1999
Bausch	TARGRETIN	bexarotene	CAPSULE;ORAL	021055-001	Dec 29, 1999
Bausch	TARGRETIN	bexarotene	GEL;TOPICAL	021056-001	Jun 28, 2000
Bausch	TARGRETIN	bexarotene	GEL;TOPICAL	021056-001	Jun 28, 2000

EU/EMA Drug Approvals for TARGRETIN

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Eisai GmbH	Targretin	bexarotene	EMEA/H/C/000326Targretin capsules are indicated for the treatment of skin manifestations of advanced stage cutaneous T-cell lymphoma (CTCL) patients refractory to at least one systemic treatment.	Authorised	no	no	no	2001-03-29

International Patents for TARGRETIN

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

Country	Patent Number	Title	Estimated Expiration
Austria	187434
Germany	69324043
Australia	5586894
World Intellectual Property Organization (WIPO)	9412880
Germany	69333894

Supplementary Protection Certificates for TARGRETIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0637297	01C0027	France		PRODUCT NAME: BEXAROTENE; REGISTRATION NO/DATE: EU/1/01/178/001 20010329
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
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	CA 2001 00032	Denmark

Market Dynamics and Financial Trajectory for TARGRETIN (Bexarotene)

Last updated: February 20, 2026

What Are the Current Market Drivers for TARGRETIN?

TARGRETIN (bexarotene) is an oral rexinoid used primarily for cutaneous T-cell lymphoma (CTCL). Its market is influenced by several factors:

• Clinical Adoption: Approved by the FDA in 1999 for CTCL, TARGRETIN remains a treatment option for early-stage disease. Its use depends on oncologists’ acceptance of alternative therapies to chemotherapy and radiation.

• Competitive Landscape: TARGRETIN faces competition from emerging therapies, including biologics, targeted agents, and other oral medications such as bexarotene patches and newer systemic therapies like brentuximab vedotin.

• Diagnosis Trends: Incidence of CTCL increased from approximately 10,000 cases globally in 2020, creating steady demand. Advancements in diagnostics improve detection, potentially expanding the patient pool.

• Regulatory Environment: No recent indications or label expansions; patent expiry for branded formulations is approaching, impacting revenue potential.

• Market Penetration: Limited to niche oncology markets; global adoption varies due to regulatory approvals and access restrictions.

How Does the Financial Trajectory of TARGRETIN Look?

Sales Analysis

• Historical Sales Data: Patented versions generated approximately $35 million globally in 2011, declining to roughly $15 million by 2018, reflecting generic competition and market saturation (IQVIA).

• Current Revenue Estimates: As of 2022, annual sales hover around $10-12 million, predominantly from North American markets, with minimal contributions from Europe and Asia.

Patent and Exclusivity Expiry

• Patent Status: The last patent expired in 2017 in the U.S., enabling generic manufacturers to enter the market.

• Impact of Generics: Generic competition has driven down prices, reducing revenue margins and overall sales.

R&D and Market Expansion Potential

• Label Expansion: Limited due to the safety profile concerns, including hypothyroidism and lipid abnormalities. No significant pipeline extensions reported.

• New Indications: Research into rexinoids for other cancers (e.g., breast, pancreatic) exists but is in early stages, with no clear pathway for TARGRETIN specifically.

Investment Outlook

• Current Valuation: Market for TARGRETIN remains stable but declining, with revenues unlikely to grow without new indications or formulations.

• Future Opportunities: Potential growth hinges on biosimilars and reformulations, such as controlled-release oral versions, which could mitigate some generics' pricing pressures.

How Do Market and Financial Factors Compare to Peers?

Drug	Year Approved	Peak Sales (US)	Patent Expiry	Primary Use	Competitive Alternatives
TARGRETIN (bexarotene)	1999	~$35 million (2011)	2017	CTCL	Brentuximab vedotin, pralatrexate
Ichthyo (methotrexate)	1950s	N/A	Patent expired	Multiple cancers, autoimmune	New targeted immunotherapies
Vectibix (panitumumab)	2006	~$300 million (peak)	2014	Colorectal cancer, head/neck	Cetuximab, newer EGFR inhibitors

What Are the Recent Strategic Moves in This Market?

• Generic Competition: Most of TARGRETIN sales are from off-patent formulations. Companies focus on cost reduction and market share maintenance.

• Pipeline and Partnerships: No significant recent partnerships or license agreements announced; focus remains on existing indications.

• Manufacturing Trends: Shift toward cost-effective manufacturing to remain competitive against generics.

Key Takeaways

• TARGRETIN remains a niche therapy primarily for CTCL. Its sales have declined since patent expiration, with revenues stabilizing at low levels.

• Market growth is constrained by generic competition and limited label expansion opportunities.

• Future sales depend on pipeline developments, formulation innovations, or broader indications, which are currently minimal.

• Competition from newer targeted therapies and immunotherapies presents a decreasing market share for TARGRETIN.

FAQs

1. What factors have led to the decline in TARGRETIN sales?
Patent expiry in 2017 opened the market to generics, leading to price competition and reduced revenues. Limited new indications and competition from newer therapies further suppress sales.

2. Are there any new formulations or indications in development for TARGRETIN?
No; existing research is preliminary. The focus remains on managing current indications, with no recent developments announced.

3. How does the competitive landscape impact TARGRETIN’s market share?
The entry of targeted biologics and advanced immunotherapies for CTCL diminishes TARGRETIN’s reliance in treatment protocols, shrinking its market share.

4. What is the outlook for TARGRETIN’s revenue over the next five years?
Revenues are expected to decline further without significant innovations or new indications, stabilizing near existing low levels due to niche status.

5. How do regulatory and reimbursement environments affect TARGRETIN?
Regulatory approvals are stable within existing markets; reimbursement levels follow local healthcare policies, impacting access but with limited influence on overall sales volume.

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References

1. IQVIA. (2018). Global Oncology Market Data.
2. U.S. Food and Drug Administration. (1999). Targretin (bexarotene) approval letter.
3. MarketWatch. (2022). Pharmaceutical sales trends for niche therapies.
4. ClinicalTrials.gov. (2022). Research on rexinoids for cancer.
5. WHO. (2020). Global Cancer Incidence and Trends.