TAZAROTENE - Generic Drug Details

What are the generic sources for tazarotene and what is the scope of patent protection?

Tazarotene is the generic ingredient in five branded drugs marketed by Mayne Pharma, Almirall, Cosette, Fougera Pharms Inc, Padagis Israel, Sun Pharma Canada, Solaris Pharma Corp, and Bausch, and is included in thirteen NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Tazarotene has fifty-four patent family members in twenty-four countries.

There are eight drug master file entries for tazarotene. Ten suppliers are listed for this compound.

Summary for TAZAROTENE

International Patents:	54
US Patents:	6
Tradenames:	5
Applicants:	8
NDAs:	13
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	10
Raw Ingredient (Bulk) Api Vendors:	89
Clinical Trials:	55
Patent Applications:	7,862
Drug Prices:	Drug price trends for TAZAROTENE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TAZAROTENE
What excipients (inactive ingredients) are in TAZAROTENE?	TAZAROTENE excipients list
DailyMed Link:	TAZAROTENE at DailyMed

See drug prices for TAZAROTENE

Recent Clinical Trials for TAZAROTENE

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

Sponsor	Phase
Duke University	NA
National Rosacea Society	NA
Assiut University	PHASE4

See all TAZAROTENE clinical trials

Pharmacology for TAZAROTENE

Drug Class

Retinoid

Anatomical Therapeutic Chemical (ATC) Classes for TAZAROTENE

D05AX	Other antipsoriatics for topical use
D05A	ANTIPSORIATICS FOR TOPICAL USE
D05	ANTIPSORIATICS
D	Dermatologicals

Paragraph IV (Patent) Challenges for TAZAROTENE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ARAZLO	Topical Lotion	tazarotene	0.045%	211882	1	2022-05-12

US Patents and Regulatory Information for TAZAROTENE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cosette	TAZAROTENE	tazarotene	GEL;TOPICAL	214136-001	Sep 13, 2022	AB	RX	No	No
Padagis Israel	TAZAROTENE	tazarotene	GEL;TOPICAL	213079-002	Apr 25, 2023	AB	RX	No	No
Almirall	TAZORAC	tazarotene	CREAM;TOPICAL	021184-002	Sep 29, 2000	AB	RX	Yes	Yes
Padagis Israel	TAZAROTENE	tazarotene	CREAM;TOPICAL	217075-001	Jul 15, 2024	AB	RX	No	No

Expired US Patents for TAZAROTENE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	ARAZLO	tazarotene	LOTION;TOPICAL	211882-001	Dec 18, 2019	6,517,847
Almirall	TAZORAC	tazarotene	GEL;TOPICAL	020600-001	Jun 13, 1997	5,914,334
Almirall	TAZORAC	tazarotene	GEL;TOPICAL	020600-002	Jun 13, 1997	6,258,830
Almirall	AVAGE	tazarotene	CREAM;TOPICAL	021184-003	Sep 30, 2002	5,089,509

International Patents for TAZAROTENE

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2400951
Mexico	2011008912
Eurasian Patent Organization	020844
Japan	7410720

Supplementary Protection Certificates for TAZAROTENE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0031058	98C0008	Belgium		PRODUCT NAME: TAZAROTENE; NAT. REGISTRATION NO/DATE: NL22604 19970922; FIRST REGISTRATION: DE - 37393.00.00 19961203
0284288	12/1998	Austria		PRODUCT NAME: TAZAROTENE; NAT. REGISTRATION NO/DATE: 1-22102, 1-22103 19970918; FIRST REGISTRATION: DE 37393.00.00, 37393.01.00 19961203
0284288	SPC/GB98/002	United Kingdom		PRODUCT NAME: TAZAROTENE : ETHYL 6-(2-(4,4-DIMETHYLTHIOCHROMAN-6-YL) ETHYNYL) NICOTINOATE; REGISTERED: DE 37393.00.00 19961203; DE 37393.01.00 19961203; UK 00426/0097 19970730; UK 00426/0096 19970730

Market Dynamics and Financial Trajectory for Tazarotene

Last updated: July 27, 2025

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Introduction

Tazarotene, a topical retinoid primarily used for the treatment of acne vulgaris, plaque psoriasis, and other dermatological conditions, has carved a niche within the dermatology therapeutic market. Its market dynamics and financial trajectory are influenced by regulatory, clinical, competitive, and socio-economic factors, which collectively determine its revenue generation potential and long-term sustainability.

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Pharmacological Profile and Therapeutic Use

Tazarotene is a third-generation retinoid, chemically a prodrug of tazarotenic acid. Its mechanism involves modulation of gene expression affecting keratinocyte differentiation and proliferation. Approved by the U.S. Food and Drug Administration (FDA) in 1997, its indications extend to acne vulgaris, psoriasis, and other hyperkeratotic dermatological disorders ([1]).

Its efficacy, combined with a tolerability profile, has cemented its role as a second-line topical therapy for severe dermatological conditions. The topical formulation's targeted delivery minimizes systemic exposure, making it a preferred option for localized skin conditions.

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Market Overview and Drivers

Market Size and Growth Trends

The global dermatology drug market, valued at approximately USD 25 billion in 2022, is projected to grow at a CAGR of approximately 7% through 2030 ([2]). Tazarotene, as part of this category, largely benefits from incremental growth driven by rising dermatological disorder prevalence, especially acne and psoriasis, across developing and developed economies.

Demographic and Epidemiologic Factors

The rising incidence of acne among adolescents and young adults globally sustains demand. Psoriasis prevalence remains steady at 2-3% worldwide, with increasing diagnosis rates attributable to improved awareness and diagnostic techniques. Urbanization and lifestyle changes further escalate skin disease burdens, thereby bolstering demand for retinoid therapies, including tazarotene.

Regulatory and Clinical Developments

While tazarotene remains a primarily prescription-based product, ongoing research evaluates its combination with other agents to enhance efficacy. Regulatory bodies maintain stringent safety profiles, primarily concerning teratogenicity, which limits over-the-counter availability and influences manufacturing and distribution strategies.

Competition and Market Share

Tazarotene competes with other topical agents such as tretinoin, adapalene, and newer biologics for psoriasis. While biologics dominate in moderate-to-severe psoriasis, topical agents maintain dominance in mild-to-moderate cases. Tazarotene's advantage lies in its targeted action and relatively low systemic absorption, but its tolerability issues can buffer its market expansion.

Market Challenges

• Side Effect Profile: Common adverse effects include erythema, peeling, and irritation, which can affect patient adherence.
• Teratogenic Risks: Pregnant women are contraindicated, necessitating cautious prescribing and patient education, which poses market entry barriers in certain regions.
• Pricing and Reimbursement: Limited reimbursement and price pressures in certain markets constrain sales growth, especially for generic formulations.

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Financial Trajectory and Revenue Outlook

Revenue Generation

Branding and patent status significantly influence the revenue trajectory of tazarotene products. While Tazorac (marketed by Allergan) was a leading branded formulation for years, patent expirations and the subsequent rise of generics have compressed profit margins. Nevertheless, robust demand for topical retinoids ensures steady revenue streams, particularly in dermatology clinics.

Impact of Patent Expiry and Generics

Patent lapses for tazarotene formulations typically occur around the late 2010s, leading to increased generic competition. This has driven down wholesale prices and marginal profit margins for originators, impacting overall revenue unless innovation or combination therapies are introduced.

Emerging Markets and Expansion Opportunities

Developing economies—such as China, India, and parts of Southeast Asia—offer burgeoning dermatology markets with increasing healthcare access and awareness. Companies investing in marketing, local manufacturing, and registration can leverage these opportunities for revenue expansion.

R&D and Pipeline Prospects

Current pipelines focus on stable, combination, and novel formulations, such as Tazarotene-loaded nanoparticles or combination with biologics, intended to improve tolerability and efficacy. Such innovations could rejuvenate the product’s revenue potential and extend patent exclusivity.

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Key Market Players and Strategic Movements

• Allergan (AbbVie): Historically dominant with Tazorac, now faces competition from generics.
• Actavis: Previously marketed generic tazarotene formulations, contributing to price competition.
• Emerging biotech firms: Exploring novel topical retinoids and combination therapies to carve market share.

Strategic movements include partnering with local distributors in emerging markets, investing in R&D for combination therapies, and pursuing formulation innovations to enhance tolerability and patient adherence.

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Regulatory and Pricing Outlook

Future market growth hinges upon regulatory policies, especially concerning safety profiles and positioning for improved formulations. Manufacturers must navigate the global landscape of drug approval, reimbursement policies, and safety monitoring. Price controls in certain regions, notably Europe and Asia, impact revenue potential, necessitating strategic market segmentation.

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Future Market Trends

• Personalized Medicine: Tailoring retinoid therapy based on genetic and phenotypic patient profiles could drive market differentiation.
• Digital and Teledermatology: These platforms can facilitate better patient education and adherence, influencing sales.
• Combination Regimens: Formulations combining tazarotene with anti-inflammatory agents can expand indications and improve market share.

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Conclusion

The financial trajectory of tazarotene hinges on its positioning within the dermatology market, regulatory landscape, and innovation pipeline. While patent expiries and generic competition pose challenges, expanding demand in emerging markets and ongoing formulation improvements offer growth avenues. Strategic emphasis on safety, efficacy, and patient adherence will underpin its long-term market sustainability.

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Key Takeaways

• Market Demand: Rising prevalence of acne and psoriasis sustains steady demand for tazarotene, particularly in emerging markets.
• Competitive Dynamics: Patent expiries have intensified generic competition, compressing margins but maintaining overall sales volumes.
• Innovation Opportunities: Formulation improvements and combination therapies present pathways to extend market relevance.
• Regulatory Considerations: Teratogenicity and safety profiles influence prescribing patterns, especially in sensitive populations.
• Growth Strategies: Market expansion in developing economies and digital health integration are critical for future revenue growth.

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FAQs

1. What factors are influencing the decline of branded tazarotene products?
Patent expiries and the introduction of generic formulations have increased price competition, reducing profit margins for brand-name products like Tazorac. Additionally, market saturation and competition from other topicals limit revenue growth.

2. How does safety profile impact tazarotene’s market trajectory?
Concerns over teratogenicity and skin irritation restrict use in certain populations, necessitating strict contraindications, patient education, and monitoring, which can hinder broader market penetration.

3. Are there innovations that could extend tazarotene's market relevance?
Yes. Combination formulations with anti-inflammatory agents, improved delivery systems (like nanoparticles), and novel topical delivery methods could enhance efficacy, tolerability, and adherence.

4. What is the outlook for tazarotene in emerging markets?
Growing prevalence of dermatological conditions and increasing healthcare access present substantial growth opportunities. Low-cost generics further facilitate market entry, although regulatory and local patent laws influence expansion strategies.

5. How do regulatory policies shape future sales of tazarotene?
Safety concerns lead to stringent regulations, affecting labeling, prescribing, and marketing. Strong safety monitoring and approval of innovative formulations can unlock new revenue streams.

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References

[1] U.S. FDA Drug Approvals. Tazarotene. 1997.
[2] IBISWorld. Global Dermatology Drug Market Report. 2022.