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 is one drug master file entry 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:	3,196
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 Medical Research Council (NMRC), Singapore	Phase 1
National Cancer Centre, 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	GEL;TOPICAL	021056-001	Jun 28, 2000
Bausch	TARGRETIN	bexarotene	GEL;TOPICAL	021056-001	Jun 28, 2000
Bausch	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	4636893
Australia	5869394
Australia	700706
Brazil	9307528
Canada	2149882

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	SPC013/2001	Ireland		SPC013/2001: 20031205, EXPIRES: 20160328
0637297	CA 2001 00032	Denmark
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	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.

Last updated: July 26, 2026

Targretin (bexarotene) market dynamics and financial trajectory: sales history, drivers, exclusivity, and competitive pressure

Targretin (bexarotene) is a single-product branded franchise in the FDA market for cutaneous manifestations of mycosis fungoides (MF) and, in the U.S., is used under the agency label in specific disease settings. Commercial dynamics are shaped by (1) limited eligible population, (2) long-term prescribing behavior in MF, (3) discontinuous demand linked to treatment sequencing and payer controls, and (4) competitive pressure from other MF therapies rather than direct generic substitution. Because Targretin is an older, specialty oncology/dermatology agent with a mature safety profile and established treatment patterns, its financial trajectory typically follows broad specialty-drug class trends more than short-cycle product launches.

Primary commercialization takeaway: Targretin’s financial path has been defined by niche-volume sales, insurer step edits, and MF regimen switching rather than by generic erosion in major markets.

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What is Targretin (bexarotene) used for and where is it sold?

Indications with U.S. label scope that constrain addressable market

Targretin is prescribed for:

• Cutaneous manifestations of mycosis fungoides (MF), including both refractory and disease stages where bexarotene is used in dermatology-led oncology care pathways.

Label scope matters commercially because MF is low-prevalence and therapy selection is fragmented across dermatology and oncology practices.

Specialty channel dynamics

• Primary demand is concentrated in specialty prescribers managing chronic MF.
• Distribution is specialty pharmacy and wholesaler order patterns rather than broad retail.

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How has Targretin’s sales trajectory evolved over time?

Financial trajectory drivers

Targretin’s sales have historically been affected by:

• Patient pool durability: MF treatment is chronic, but durable demand depends on disease progression management and clinician preferences.
• Therapy switching: On-treatment response and tolerability can lead clinicians to rotate among phototherapy, interferons, HDAC inhibitors, retinoids, immune modulating agents, and newer targeted options.
• Payer controls: Coverage policies for MF and prior authorization requirements can tighten effective demand.
• Tolerability management: Bexarotene’s class effects can create monitoring burdens (lipids, thyroid function), which influences adherence and continuation.
• Formulation mix: In practice, utilization depends on which formulation is preferred for tolerability, dosing convenience, and clinician experience.

What typically shows up in the financial line item

Even without exact year-by-year totals here, Targretin’s observed commercial shape for similar specialty niche brands generally maps to:

• A mature baseline after peak uptake,
• Gradual declines tied to competitive switching,
• Periodic stabilization when prescriber cohorts remain anchored in established retinoid protocols,
• Down-cycles when payers add utilization management.

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What market dynamics affect demand for Targretin in mycosis fungoides?

Patient population and treatment sequencing

MF is the primary driver of the bexarotene market:

• Low incidence and heterogeneous staging reduce addressable volume.
• Treatment sequencing is clinician- and site-specific, so bexarotene demand can shift when new regimens gain dominance in guidelines.

Prescriber behavior in chronic dermatologic oncology

• Many MF patients cycle through multiple therapies, so market share is not “win or lose” once.
• Sustained share requires consistent tolerability outcomes and payer acceptance.

Payer economics and utilization management

Common levers that influence effective market demand:

• Prior authorization thresholds tied to MF stage and refractory status.
• Quantity limits and step therapy.
• Formulary placement changes after contracting cycles.

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How does Targretin compete versus other mycosis fungoides treatments?

Direct vs indirect competition

There is limited direct substitution with bexarotene itself, so commercial pressure is largely indirect:

• Competing MF regimens compete for the same refractory or persistent patient segments.
• New entrants that show improved response durability or better tolerability can displace bexarotene in sequencing.

Competitive categories

MF standard-of-care alternatives often include:

• Phototherapy (e.g., UV-based approaches),
• Topical and systemic immunomodulators,
• Interferons,
• HDAC inhibitors,
• Newer targeted or immune-modulating therapies depending on patient and disease context.

Market outcome implication: Targretin’s revenue line is more sensitive to guideline and payer shifts than to immediate generic price compression.

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Is Targretin exposed to generic competition or biosimilar risk?

Generic competition

Targretin’s commercial exposure is tied to whether generic bexarotene products have meaningful market penetration and whether they are therapeutically interchangeable under payer policy.

• For a mature specialty brand, generic entry typically shifts market share quickly among price-sensitive payers.
• In practice, niche dermato-oncology segments can retain branded penetration if prescribers are entrenched or if payer contracting favors the incumbent.

Biosimilar risk

Biosimilar risk is not applicable because bexarotene is a small molecule.

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What do exclusivity and patent cliffs mean for Targretin’s revenue?

How patent expiration translates to revenue risk

For niche branded small molecules:

• Patent expiration can lead to generic entry and net-price decline.
• The magnitude depends on whether generics are launched promptly, whether payers prefer them, and whether clinicians maintain branded use.

Revenue timing pattern after exclusivity

Typical branded revenue patterns after meaningful IP events:

• Gross-to-net pressure from higher discounting,
• Volume shift to lower-priced versions,
• Residual branded demand if payer coverage remains mixed or if switching requires clinical justification.

Business implication: Targretin’s revenue path would track generic entry timing and formulary adoption pace rather than clinical endpoints.

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What is the Orange Book status of Targretin and how many patents cover it?

No Orange Book dataset or patent list is included in the prompt. Under this constraint, this analysis cannot provide reliable Orange Book coverage counts, patent numbers, or expiration timelines without risking incorrect legal and regulatory detail.

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What formulation and method-of-use intellectual property affects market access for Targretin?

No formulation patent list or method-of-use patent summary is included in the prompt. Without a verified patent inventory, it is not possible to provide an accurate “how many patents” count or to map which claims control generic formulation, dosing form, or dosing regimens.

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What Paragraph IV challenges or ANDA litigation would affect Targretin?

No verified ANDA/Paragraph IV history is provided in the prompt. Without case-specific details, it is not possible to state which generics challenged, whether a settlement occurred, or what the litigation stay period timing was.

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What FDA regulatory pathway and label changes influence Targretin utilization?

Label-driven demand

For specialty drugs:

• Label expansions can broaden eligible segments.
• Safety communications or restrictive updates can dampen utilization.
• Minor label updates can still affect payer criteria if coverage policies hard-code label language.

No FDA label-change chronology is included in the prompt.

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What commercial KPIs track Targretin performance in practice?

High-signal KPIs for a niche specialty brand like Targretin:

• TRx and patient starts: early indicators of treatment adoption or switching.
• Persistence/continuation rate: impacts long-run revenue given chronic use.
• Wholesale inventory and buy-sell patterns: helps separate true demand from channel stocking.
• Net price and contract coverage: net-to-gross reveals payer intensity.
• Formulation mix: if multiple dosage forms exist in the market, mix can shift due to tolerability and dosing convenience preferences.
• Market share within MF lines: measured against competing MF regimens rather than general oncology categories.

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Revenue exposure map: what most likely drives Targretin upside or downside?

Downside drivers

• Increased payer utilization management.
• Treatment sequencing shift away from retinoids.
• Increased competing therapy uptake.
• Any escalation of safety monitoring constraints that reduce patient persistence.

Upside drivers

• Stable guideline inclusion for MF segments where bexarotene is considered.
• Improved tolerability management reducing discontinuation.
• Payer contract retention for specialty centers where bexarotene remains a standard line option.

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Key Takeaways

• Targretin’s market is defined by mycosis fungoides patient eligibility and chronic prescribing behavior, not by high-volume uptake dynamics.
• Demand is driven by treatment sequencing and payer controls, with competition largely indirect from other MF regimens.
• Generic and exclusivity events would materially affect net revenue, but biosimilar risk does not apply to bexarotene.
• The most predictive commercial indicators are TRx starts, persistence, net price under payer contracts, and formulation mix, not broad oncology market growth.

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FAQs

1) What patient segments within mycosis fungoides drive Targretin volume most?
Refractory and persistent cutaneous MF segments where bexarotene is used as a systemic option under dermatology-oncology treatment sequencing.

2) How do payers typically manage coverage for bexarotene in MF?
Through prior authorization and step edits based on MF staging, refractory status, and documentation of prior therapy exposure.

3) What tolerability and monitoring factors most affect Targretin persistence?
Bexarotene class safety effects that require ongoing monitoring can reduce continuation if management is burdensome for certain patients.

4) What competitive therapies most commonly displace Targretin in treatment sequencing?
Other systemic and skin-directed MF therapies that offer better response rates, tolerability, or convenience for the relevant refractory cohorts.

5) Does Targretin face biosimilar competition?
No. It is a small-molecule retinoid, so biosimilar risk is not applicable.

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References (APA)

No sources were provided or cited in the prompt; therefore, no reference list can be generated.