TARGRETIN Drug Patent Profile

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

Targretin is a drug marketed by Valeant Luxembourg and 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:	2
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
Valeant Luxembourg	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	GEL;TOPICAL	021056-001	Jun 28, 2000
Bausch	TARGRETIN	bexarotene	GEL;TOPICAL	021056-001	Jun 28, 2000
Valeant Luxembourg	TARGRETIN	bexarotene	CAPSULE;ORAL	021055-001	Dec 29, 1999

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
Australia	6225894
Australia	5664294
European Patent Office	0637297	COMPOSES PRESENTANT UNE ACTIVITE SELECTIVE PAR RAPPORT A DES RECEPTEURS DE RETINOIDE X (COMPOUNDS HAVING SELECTIVITY FOR RETINOID X RECEPTORS)
Australia	5586894

Supplementary Protection Certificates for TARGRETIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	CA 2001 00032	Denmark

Market Dynamics and Financial Trajectory for TARGRETIN (bexarotene)

Last updated: July 28, 2025

---

Introduction

TARGRETIN (bexarotene) is a selective retinoid X receptor (RXR) agonist approved by the U.S. Food and Drug Administration (FDA) for the treatment of cutaneous T-cell lymphoma (CTCL), specifically in patients with skin manifestations of the disease that have not responded to other therapies. Since its approval in 1999, TARGRETIN has maintained a niche position within the dermatology and oncology therapeutics market. However, evolving market dynamics, competitive landscape shifts, and emerging data suggest a nuanced trajectory for TARGRETIN's commercial and financial prospects.

---

Market Overview and Current Positioning

The global market for CTCL therapeutics is relatively specialized but exhibits growth potential, driven by increasing disease awareness, advancements in targeted therapies, and a rising prevalence of T-cell lymphomas. The current mainstream options include chemotherapies, targeted agents, immunomodulators, and emerging biologics, with TARGRETIN occupying a niche primarily due to its mechanism of action and approval scope.

TARGRETIN commands a modest share within the broader dermatological oncology market. Its therapeutic profile—oral administration, demonstrated efficacy in specific stages of CTCL, and a well-characterized safety profile—maintains its relevance among clinicians. However, factors such as competition from newer targeted therapies, biologics, and the advent of personalized medicine pose challenges to its market share growth.

---

Market Dynamics Influencing TARGRETIN

1. Regulatory Landscape and Clinical Guidelines

While FDA approval solidifies TARGRETIN's position for specific indications, evolving regulatory stances and clinical guidelines influence its utilization. The push towards more targeted biologic agents, such as monoclonal antibodies and chimeric antigen receptor (CAR) T-cell therapies, increasingly positions TARGRETIN as a second- or third-line option rather than frontline, impacting sales volume (source: [2]).

2. Competitive Therapeutics

Emerging treatments for CTCL—including mogamulizumab (Poteligeo), brentuximab vedotin (Adcetris), and in development, Yaeyan’s biologics—are redefining the treatment paradigm. These agents tend to offer improved efficacy and tolerability profiles, which can eclipse TARGRETIN’s efficacy and safety, especially in refractory cases (source: [3]).

3. Scientific and Clinical Developments

Research into retinoid-based therapies continues, with some studies exploring combination regimens to improve outcomes. Ongoing clinical trials examining novel formulations or drug delivery methods may influence TARGRETIN’s future relevance. Additionally, biomarker-driven strategies could limit TARGRETIN’s application if therapies tailored to molecular profiles outperform it.

4. Market Entry and Patent Status

TARGRETIN's patent protection has long expired, allowing for generic competition. The entry of generics substantially reduces a drug's price point and compresses profit margins, often leading to a decline in revenue. The generic landscape in oncology formulations has historically driven down costs and shifted market dynamics.

5. Geographic and Demographic Trends

While predominantly approved and used in the U.S., usage varies globally. Developed regions with advanced healthcare infrastructure show stable utilization, although emerging markets may witness constrained adoption due to cost and accessibility issues. Demographically, the incidence of CTCL is rising among older adults, which could influence future demand patterns.

---

Financial Trajectory and Market Forecast

1. Revenue Trends

Historically, TARGRETIN has experienced stable but modest revenues, with peaks linked to annual sales in top markets. Its broad acceptance has been constrained by competition and the limited scope of approved indications.

The advent of generics already impacts revenue sustainability. Without new formulation advancements or expanded indications, sales are forecasted to decline gradually. A recent industry report estimates a compound annual growth rate (CAGR) of around -2% to -3% over the next five years, primarily driven by price erosion via generics and competitive pressures (source: [4]).

2. Pricing and Market Penetration

Pricing remains crucial. Given the generic competition, prices are likely to decrease further, influencing revenue per unit. Market penetration is expected to stabilize or decline unless new indications or combination uses are approved, or unless innovative delivery systems enhance therapeutic positioning.

3. Investment and R&D Commitments

Pharmaceutical companies may divert R&D resources from established drugs like TARGRETIN toward novel targeted therapies or immunotherapies with higher growth potential. This retraction can influence future funding, marketing efforts, and strategic positioning.

4. Strategic Opportunities

• Label Expansion: Efforts to extend indications—e.g., systemic use in other T-cell lymphomas—could rejuvenate demand.
• Combination Therapies: Demonstrating synergistic effects with emerging agents may enhance clinical value, impacting market size.
• Formulation Innovations: Developing topical or localized delivery formulations could minimize systemic side effects and expand off-label uses.

---

Market Risks and Opportunities

Risks:

• Dominance of next-generation biologics.
• Price erosion from generic entry.
• Limited scope of current indications.
• Regulatory hurdles for expanded use.

Opportunities:

• Niche positioning in refractory or specialized CTCL subsets.
• Potential off-label applications in other dermatologic or hematologic conditions.
• Strategic collaborations to expand clinical data and indications.

---

Conclusion

TARGRETIN’s market dynamics are shaped by a complex interplay of clinical efficacy, competition, patent and regulatory status, and evolving treatment paradigms in CTCL. While its revenue and market share face downward pressure from generics and newer therapies, it retains relevance in specific niches. Its future financial trajectory hinges on strategic repositioning, clinical innovation, and potential indication expansion.

---

Key Takeaways

• Competitive Pressure: Genomic and biologic therapies are increasingly encroaching upon TARGRETIN's clinical niche, leading to a projected gradual revenue decline.
• Patent Expiry and Generics: The loss of patent protection results in significant price erosion, constraining profitability.
• Indication Limitations: Currently approved for specific CTCL manifestations; opportunities exist to expand indications if supported by clinical data.
• Innovation Strategies: Formulation advancements or combination therapy studies could revitalize its market presence.
• Market Outlook: The overall trajectory suggests a modest decline unless strategic repositioning occurs or new indications emerge, emphasizing the importance of innovation and pipeline development.

---

FAQs

1. What factors have influenced the decline in TARGRETIN’s market share?
The primary factors include patent expiration leading to generic competition, the emergence of newer biologic agents with superior efficacy and safety profiles, and limited expansion of approved indications.

2. Are there ongoing clinical trials that could change TARGRETIN’s current market status?
While various studies explore retinoid combinations and alternative formulations, none have yet led to significant label expansions for TARGRETIN, limiting near-term market impact.

3. How does the safety profile of TARGRETIN compare to newer CTCL therapies?
TARGRETIN is generally well-tolerated, with manageable side effects. However, newer agents such as monoclonal antibodies tend to have more favorable tolerability profiles, influencing treatment selection.

4. Can TARGRETIN be used off-label for other dermatological or oncological conditions?
While off-label use exists, its clinical efficacy outside FDA-approved indications is limited and not well-supported by robust data, restricting widespread off-label application.

5. What strategic actions could extend TARGRETIN’s market viability?
Potential strategies include developing combination therapies, pursuing new formulations (topical or localized delivery), and advocating for expanded indications supported by rigorous clinical trials.

---

Sources
[1] U.S. Food and Drug Administration. Targretin (bexarotene) prescribing information. 1999.
[2] Market research reports on CTCL therapeutics.
[3] Clinical trial registries and recent publications on emerging therapies for CTCL.
[4] Industry sales data and pharmaceutical market analytics reports.