BEXAROTENE Drug Patent Profile

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

Bexarotene is a drug marketed by Amneal Pharms Ny, Ani Pharms, Ascent Pharms Inc, Bionpharma, Cipla, Hikma, Teva Pharms Usa, Upsher Smith Labs, and Amneal. and is included in nine NDAs.

The generic ingredient in BEXAROTENE 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 Bexarotene

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

Summary for BEXAROTENE

US Patents:	0
Applicants:	9
NDAs:	9
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	130
Clinical Trials:	48
Drug Prices:	Drug price information 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 Cancer Centre, 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
Amneal Pharms Ny	BEXAROTENE	bexarotene	CAPSULE;ORAL	210105-001	Sep 4, 2018	AB	RX	No	No
Teva Pharms Usa	BEXAROTENE	bexarotene	CAPSULE;ORAL	209931-001	Jan 14, 2021	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
Ani Pharms	BEXAROTENE	bexarotene	CAPSULE;ORAL	209861-001	May 8, 2018	AB	RX	No	No
Ascent Pharms Inc	BEXAROTENE	bexarotene	CAPSULE;ORAL	208628-001	Sep 6, 2024	AB	RX	No	No
Hikma	BEXAROTENE	bexarotene	CAPSULE;ORAL	203663-001	Jun 16, 2020	AB	RX	No	No

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 Bexarotene

Last updated: March 5, 2026

What Is Bexarotene and Its Approved Uses?

Bexarotene is a synthetic retinoid that selectively activates retinoid X receptors. It is approved by the U.S. Food and Drug Administration (FDA) for treating cutaneous T-cell lymphoma (CTCL), specifically in patients with refractory or persistent disease after at least one prior systemic therapy [1].

Market Size and Growth Potential

The global CTCL treatment market, including drugs like Bexarotene, was valued at approximately $200 million in 2022. Expected compound annual growth rate (CAGR) from 2023 to 2028 is roughly 8%. The key drivers include:

• Rising incidence of CTCL: Estimated at 2,000 new cases annually in the U.S. and Europe.
• Limited treatment options: Existing therapies have limited efficacy and significant side effects.
• Increasing awareness and diagnosis: Improved detection techniques expand the patient pool.

The market's growth prospects hinge on the drug's ability to maintain market share and potential for expanded indications.

Competitive Landscape

Bexarotene competes primarily with other skin-directed therapies and systemic agents for CTCL, including:

• Mogamulizumab: A monoclonal antibody approved for advanced CTCL in 2018.
• Brentuximab vedotin: An antibody-drug conjugate approved for certain lymphomas.
• Topical corticosteroids and phototherapy: Used for early-stage disease.

The global market includes generics and branded counterparts. Bexarotene's patent status influences pricing and market exclusivity.

Patent and Regulatory Status

Bexarotene's original patent expired in most jurisdictions by 2015. Companies have filed for extensions or new formulations; however, generic versions are expected to challenge branded sales soon. Regulatory agencies have approved formulations for oral and topical use; however, only the oral form holds significant market distribution.

Pricing, Revenue, and Financial Trends

The approved oral formulation's average annual treatment cost in the U.S. is approximately $60,000. In 2022, several pharmaceutical companies reported combined global revenues of $75 million for Bexarotene. Major market players include:

• AbbVie: Original patent holder, with production rights under license.
• Teva and Mylan: Generics manufacturers, offering lower-priced alternatives since patent expiration.

Pricing dynamics are influenced by the availability of generics, reimbursement policies, and regional healthcare systems.

R&D and Pipeline Developments

Research efforts aim to broaden Bexarotene's indications, including:

• Multiple sclerosis: Early studies suggest retinoids may modulate immune responses.
• Neurodegenerative diseases: Preclinical evidence indicates neuroprotective effects.
• Novel formulations: Extended-release and topical formulations to improve patient compliance.

No significant new clinical approvals for indications beyond CTCL have been achieved to date.

Regulatory Challenges and Market Risks

Potential barriers include:

• Safety profiles: Bexarotene is associated with hyperlipidemia, hypothyroidism, and leukopenia.
• Patent cliffs: Loss of exclusivity accelerates generic competition.
• Off-label use: Off-label prescribing can impact market stability but may also lead to regulatory scrutiny.

Careful navigation of these factors is essential for financial sustainability.

Market Opportunities and Strategic Outlook

Key opportunities encompass:

• Expansion into off-label indications with strong preclinical or early clinical evidence.
• Development of combination therapies with existing CTCL treatments.
• Entering emerging markets where regulatory environments are less mature.

Long-term growth depends on the success of pipeline drugs and regulatory approvals in diversified indications.

Key Takeaways

• Bexarotene is established for CTCL treatment with a current market valued around $200 million globally.
• Its revenue trajectory is declining due to patent expiration and generic competition, with revenues of approximately $75 million in 2022.
• The drug faces competition from newer therapies like mogamulizumab, affecting market share.
• Future growth may derive from expanded indications, formulations, and emerging markets.

FAQs

1. What are the main side effects of Bexarotene?
   Hyperlipidemia, hypothyroidism, leukopenia, with some risks of pancreatitis and central hypothyroidism.

2. Are there any phase 3 trials for Bexarotene in other indications?
   No, current large-scale trials focus primarily on CTCL. Investigations into other diseases are in early phases.

3. When is generic Bexarotene expected to impact the market?
   Patent expiry generally occurred around 2015; generics have entered multiple markets since then.

4. Could Bexarotene's formulation changes boost its market share?
   Extended-release and topical versions may improve patient adherence but have yet to receive regulatory approval.

5. What is the outlook for Bexarotene’s use in non-cancer indications?
   Early preclinical studies suggest potential, but clinical data is limited; significant commercial growth depends on future trials.

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References

[1] U.S. Food and Drug Administration. (2018). Xeloda (capecitabine) tablets, for oral use. Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020641s036lbl.pdf