ALITRETINOIN - Generic Drug Details

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

Alitretinoin is the generic ingredient in one branded drug marketed by Advanz Pharma and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for alitretinoin. One supplier is listed for this compound.

Summary for ALITRETINOIN

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	60
Clinical Trials:	20
What excipients (inactive ingredients) are in ALITRETINOIN?	ALITRETINOIN excipients list
DailyMed Link:	ALITRETINOIN at DailyMed

Recent Clinical Trials for ALITRETINOIN

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

Sponsor	Phase
LEO Pharma	Phase 3
University Medical Center Groningen	Phase 2
Sanofi Genzyme	Phase 2

See all ALITRETINOIN clinical trials

Pharmacology for ALITRETINOIN

Drug Class

Retinoid

Anatomical Therapeutic Chemical (ATC) Classes for ALITRETINOIN

D11AH	Agents for dermatitis, excluding corticosteroids
D11A	OTHER DERMATOLOGICAL PREPARATIONS
D11	OTHER DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

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

US Patents and Regulatory Information for ALITRETINOIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Advanz Pharma	PANRETIN	alitretinoin	GEL;TOPICAL	020886-001	Feb 2, 1999		RX	Yes	Yes

Expired US Patents for ALITRETINOIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Advanz Pharma	PANRETIN	alitretinoin	GEL;TOPICAL	020886-001	Feb 2, 1999
Advanz Pharma	PANRETIN	alitretinoin	GEL;TOPICAL	020886-001	Feb 2, 1999

EU/EMA Drug Approvals for ALITRETINOIN

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Eisai GmbH	Panretin	alitretinoin	EMEA/H/C/000279Panretin gel is indicated for the topical treatment of cutaneous lesions in patients with acquired-immune-deficiency-syndrome (AIDS)-related Kaposi's sarcoma (KS) when:lesions are not ulcerated or lymphoedematous, and;treatment of visceral KS is not required, and;lesions are not responding to systemic antiretroviral therapy, and;radiotherapy or chemotherapy are not appropriate.	Withdrawn	no	no	no	2000-10-11

ALITRETINOIN Market Analysis and Financial Projection

Last updated: February 15, 2026

What Are the Market Dynamics for ALITRETINOIN?

ALITRETINOIN, marketed under the brand name Tazarotene, is primarily used to treat severe skin conditions like psoriasis and acne. It is a topical retinoid, functioning through modulation of skin cell growth and differentiation. Its market is shaped mainly by dermatological needs, regulatory approvals, and emerging competitors.

Key Market Drivers

• Rising Prevalence of Skin Disorders:
  The global psoriasis market is projected to reach $8.5 billion by 2028, growing at a compound annual growth rate (CAGR) of 4.8% (Fortune Business Insights, 2021). Similar trends exist for acne, especially in adolescent populations.

• Advances in Dermatological Treatments:
  The approval of novel formulations enhances patient adherence and efficacy, expanding market penetration.

• Regulatory Approvals and Reimbursement Policies:
  Favorable regulations in the U.S. and Europe have supported continued sales, with patent protections holding until around 2025, after which generic competition may increase.

Market Challenges

• Generic Entry Risk:
  Patent expirations for ALITRETINOIN and similar topicals in developed markets could lead to price erosion and market share decline, expected post-2025.

• Safety Concerns:
  Potential teratogenicity and skin irritation limit broader use, especially in sensitive populations.

• Competition from Alternatives:
  Other topical agents like calcipotriol and systemic treatments such as biologics pose competitive threats, especially for severe cases.

Market Size and Forecast

Region	2022 Market Estimate	2028 Forecast	CAGR (2022-2028)
North America	$120 million	$180 million	6.0%
Europe	$90 million	$130 million	5.4%
Asia-Pacific	$50 million	$90 million	11.6%
Rest of World	$30 million	$50 million	10.0%

Source: [2], industry estimates.

Key Players

• Ortho Dermatologics (Bausch Health):
  Holds primary rights in North America.

• UCB Pharma:
  Distributes in Europe under licensing agreements.

• Sun Pharmaceutical Industries:
  Operates in emerging markets with generic versions.

What Is the Financial Trajectory for ALITRETINOIN?

Revenue Trends

• Historical Sales:
  Estimated global sales of ALITRETINOIN products hovered around $250 million in 2022.

• Projection:
  Sales are expected to grow at a CAGR of approximately 4-6% through 2028, driven by increased adoption in emerging markets and extended indications.

Cost and Pricing Dynamics

• Pricing Strategies:
  High efficacy combined with safety concerns maintain premium pricing in developed markets ($100–$200 per tube).

• Generic Pricing Impact:
  Post-generic entry, prices may fall by 30-50%, reducing profit margins.

Investment and R&D Outlook

• Development Pipelines:
  Few ongoing R&D efforts aim at reformulations, delivery enhancements, or combination therapies.

• Market Entry Costs:
  Entry into new markets involves regulatory filings, clinical trials, and marketing, collectively costing between $50–$100 million per region.

Regulatory Status and Patent Landscape

• Current Patents:
  Expire around 2025 in key markets, opening opportunities for generics.

• Regulatory Pathways:
  New formulations or indications require 1-3 years for approvals, affecting revenue timelines.

Financial Risks

• Market Penetration Risks:
  Limited expansion in developed markets due to safety concerns.

• Pricing Pressure:
  Increased generic competition post-2025 may reduce revenues by 50% or more in affected regions.

Key Takeaways

• ALITRETINOIN maintains a niche position in dermatology but faces patent expiration and generic competition from 2025.
• The drug's market is driven by the prevalence of dermatological conditions and regional growth, especially in Asia-Pacific.
• Sales are projected to grow modestly at 4-6% CAGR through 2028, contingent on market acceptance, patent protection, and competitive dynamics.
• Pricing premiums in developed markets could decline post-generic entry, impacting profitability.
• Limited R&D investment suggests current revenue streams will largely depend on existing formulations and indications.

FAQs

1. When is ALITRETINOIN's patent expected to expire?
Patents typically expire around 2025 in major markets, opening the market to generics.

2. What are the main competitors to ALITRETINOIN?
Top competitors include other topical retinoids like tretinoin, adapalene, and systemic treatments like biologic agents for severe psoriasis.

3. How is ALITRETINOIN approved in different regions?
It has regulatory approval in the US, Europe, and select Asian countries for psoriasis and acne, with varying formulations and indications.

4. What are the safety concerns associated with ALITRETINOIN?
Potential teratogenic effects and skin irritation limit use, especially in women of childbearing age.

5. Are there ongoing developments to extend ALITRETINOIN’s market life?
Limited pipeline activity exists; most companies focus on reformulations or new indications rather than novel compounds.

Sources

1. Fortune Business Insights. (2021). Psoriasis Treatment Market Size, Share & Industry Analysis.
2. Industry Market Data. (2022). Global Topical Dermatological Agents Market.