BEXAROTENE - Generic Drug Details

What are the generic drug sources for bexarotene and what is the scope of freedom to operate?

Bexarotene is the generic ingredient in two branded drugs marketed by Amneal Pharms Ny, Ani Pharms, Ascent Pharms Inc, Bionpharma, Cipla, Hikma, Teva Pharms Usa, Upsher Smith Labs, Valeant Luxembourg, Amneal, and Bausch, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for bexarotene. Eight suppliers are listed for this compound.

Summary for BEXAROTENE

US Patents:	0
Tradenames:	2
Applicants:	11
NDAs:	11
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	130
Clinical Trials:	48
Drug Prices:	Drug price trends for BEXAROTENE
What excipients (inactive ingredients) are in BEXAROTENE?	BEXAROTENE excipients list
DailyMed Link:	BEXAROTENE at DailyMed

See drug prices for BEXAROTENE

Recent Clinical Trials for BEXAROTENE

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

Sponsor	Phase
Memorial Sloan Kettering Cancer Center	Phase 1
Case Comprehensive Cancer Center	N/A
National Medical Research Council (NMRC), Singapore	Phase 1

See all BEXAROTENE clinical trials

Pharmacology for BEXAROTENE

Drug Class

Retinoid

Anatomical Therapeutic Chemical (ATC) Classes for BEXAROTENE

L01XF	Retinoids for cancer treatment
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for BEXAROTENE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ascent Pharms Inc	BEXAROTENE	bexarotene	CAPSULE;ORAL	208628-001	Sep 6, 2024	AB	RX	No	No
Bionpharma	BEXAROTENE	bexarotene	CAPSULE;ORAL	203174-001	Aug 12, 2014	AB	RX	No	No
Upsher Smith Labs	BEXAROTENE	bexarotene	CAPSULE;ORAL	209886-001	Jul 25, 2018	AB	RX	No	No
Teva Pharms Usa	BEXAROTENE	bexarotene	CAPSULE;ORAL	209931-001	Jan 14, 2021	AB	RX	No	No
Cipla	BEXAROTENE	bexarotene	CAPSULE;ORAL	210352-001	Dec 10, 2024		DISCN	No	No

Expired US Patents for BEXAROTENE

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
Valeant Luxembourg	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 BEXAROTENE

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

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Bexarotene

Last updated: July 28, 2025

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Introduction

Bexarotene, commercially known as Targretin, is an oral retinoid primarily approved for the treatment of cutaneous T-cell lymphoma (CTCL). Since its FDA approval in 1999, bexarotene's market landscape has evolved amid changing regulatory standards, patent expirations, and emerging therapeutic alternatives. This analysis explores the current market dynamics, including demand drivers, competitive environment, regulatory factors, and financial trajectories shaping bexarotene's future prospects.

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Market Overview and Demand Drivers

Bexarotene addresses a niche yet significant segment within oncology—specifically, refractory or persistent CTCL. The incidence of CTCL is relatively low, with approximately 1,500 to 2,000 new cases annually in the U.S. [1]. Despite its limited patient base, the drug commands premium pricing due to lack of fully curative options and the severe impact of CTCL on quality of life.

Demand for bexarotene remains steady, driven by:

• Unmet Medical Need: Limited alternative therapies for relapsed or refractory CTCL promote continued use.
• Clinical Efficacy: Bexarotene's ability to induce remission in advanced CTCL sustains physician prescribing habits.
• Indications Expansion: Research exploring off-label indications, such as other T-cell lymphomas, could broaden market potential, though medicinal approval for these remains pending.

Market Dynamics and Competitive Landscape

Patents and Generic Entry:
Bexarotene’s patent life peaked around 2008, with exclusivity conferring high pricing power. However, patent expiration has led to the emergence of generic versions, exerting downward pressure on prices and margins [2].

Emerging Therapeutics:
Next-generation therapies, including immune checkpoint inhibitors like pembrolizumab and brentuximab vedotin, are gaining traction. Clinical trials suggest these agents may offer superior efficacy or better side-effect profiles in certain patient subsets, threatening bexarotene’s market share [3].

Regulatory Environment:
FDA guidance increasingly emphasizes personalized medicine and the need for robust evidence in rare diseases. Label expansions or new indications could sustain market relevance, contingent upon successful clinical trials.

Market Consolidation:
Oncology-focused pharmaceutical companies often acquire or partner to expand therapy portfolios. Strategic alliances can influence the distribution and commercialization strategies of bexarotene, either basin-market expansion or cost-sharing with biotech innovators.

Financial Trajectory and Revenue Outlook

Historical Revenue Trends:
Bexarotene historically generated annual sales exceeding $200 million in the U.S. during peak patent protection. Post-patent expiry, revenues declined sharply due to generic competition, with estimates falling below $50 million by 2021 [4].

Projection Factors:

• Patent Status: With patents long expired, revenue heavily depends on market penetration, pricing strategies, and off-label use.
• Pipeline Developments: Pending clinical trials for potential label expansion or combination therapies could reignite growth, though no data currently point to imminent market inflection points.
• Pricing Strategies: Manufacturers may adopt value-based pricing or patient assistance programs to sustain revenue streams amid generic competition.

Financial Strategies:
Pharmaceutical companies are increasingly leveraging strategic licensing, drug repurposing, or combination therapies involving bexarotene to boost sales. License agreements with emerging biotech firms could create new revenue channels if new indications are approved.

Regulatory and Market Challenges

The primary challenges facing bexarotene include:

• Patent Cliff: Accelerates revenue decline and incentivizes investment in next-generation compounds or formulations.
• Pricing Pressure: Insurers and health systems are advocating for cost-effective therapies, which could pressure manufacturers to reduce prices.
• Market Penetration Limitations: The small patient population constrains overall revenue growth; expanding indications could mitigate this effect.

Opportunities for Growth amid Challenges

Despite patent expirations, several opportunities may positively influence bexarotene's financial trajectory:

• New Indications: Clinical research into off-label uses or other rare T-cell lymphomas may enhance market longevity.
• Formulation Innovations: Development of subcutaneous or targeted delivery systems could improve administration compliance, enabling differentiation.
• Combination Therapies: Combining bexarotene with newer immunotherapies could improve response rates and rejuvenate sales.

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Conclusion

Bexarotene’s market is characterized by a mature product profile confronting typical patent expiration challenges. While current revenues are declining owing to generics and competitive therapies, strategic moves—such as pursuing new indications, formulation innovation, and combination regimens—could stabilize or expand its market share. The drug's financial trajectory will heavily depend on clinical advancements, regulatory approvals, and market acceptance of these innovations.

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Key Takeaways

• Market maturity and patent expiration have significantly reduced bexarotene’s revenue potential, emphasizing the need for strategic innovation.
• Growing competition from immunotherapies requires repositioning or indication expansion to sustain long-term relevance.
• Emerging clinical evidence for off-label or combination uses offers potential avenues for market growth.
• Pricing pressures and reimbursement challenges necessitate value-based pricing strategies to maintain profitability.
• Future success hinges on regulatory approvals for new indications, formulation improvements, and strategic collaborations.

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FAQs

1. What is the primary approved indication for bexarotene?
   Bexarotene is primarily approved for the treatment of cutaneous T-cell lymphoma (CTCL), particularly in patients with persistent or refractory disease.

2. How has patent expiry affected bexarotene’s market?
   Patent expiry led to the entry of generic competitors, resulting in significant revenue decline from peak sales, reducing pricing power and market share.

3. Are there ongoing clinical trials for new indications of bexarotene?
   Yes, clinical trials are investigating bexarotene for other T-cell lymphomas and combination therapies, aiming to expand its therapeutic applications.

4. What are the main competitive threats to bexarotene?
   The main threats include emerging immunotherapies such as pembrolizumab and brentuximab vedotin, which may offer improved efficacy and safety profiles.

5. Can innovation improve bexarotene’s future market prospects?
   Yes, development of new formulations, extension into additional indications, and strategic drug combinations can potentially reverse declining trends and create new revenue streams.

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Sources:

[1] National Cancer Institute. "Cutaneous T-cell Lymphoma."

[2] U.S. Patent and Trademark Office. Patent expiration data on bexarotene.

[3] ClinicalTrials.gov. Trials exploring new uses of bexarotene.

[4] MarketWatch. Historical sales data and revenue analysis for bexarotene.