Acitretin - Generic Drug Details

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

Acitretin is the generic ingredient in two branded drugs marketed by Alembic, Barr Labs Inc, Impax Labs Inc, Mylan, Norvium Bioscience, Sigmapharm Labs Llc, Teva Pharms Usa, and Stiefel Labs Inc, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

There are eleven drug master file entries for acitretin. Eight suppliers are listed for this compound.

Summary for acitretin

US Patents:	0
Tradenames:	2
Applicants:	8
NDAs:	8
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	119
Clinical Trials:	37
Patent Applications:	6,822
Drug Prices:	Drug price trends for acitretin
What excipients (inactive ingredients) are in acitretin?	acitretin excipients list
DailyMed Link:	acitretin at DailyMed

See drug prices for acitretin

Recent Clinical Trials for acitretin

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

Sponsor	Phase
Singapore General Hospital	Phase 4
Translational Immunology Institute	Phase 4
South Valley University	Phase 4

See all acitretin clinical trials

Pharmacology for acitretin

Drug Class

Retinoid

Medical Subject Heading (MeSH) Categories for acitretin

Keratolytic Agents

Anatomical Therapeutic Chemical (ATC) Classes for acitretin

D05BB	Retinoids for treatment of psoriasis
D05B	ANTIPSORIATICS FOR SYSTEMIC USE
D05	ANTIPSORIATICS
D	Dermatologicals

US Patents and Regulatory Information for acitretin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sigmapharm Labs Llc	ACITRETIN	acitretin	CAPSULE;ORAL	204633-002	May 22, 2015	AB	RX	No	No
Sigmapharm Labs Llc	ACITRETIN	acitretin	CAPSULE;ORAL	204633-001	May 22, 2015	AB	RX	No	No
Barr Labs Inc	ACITRETIN	acitretin	CAPSULE;ORAL	091455-001	Apr 4, 2013	AB	RX	No	No
Stiefel Labs Inc	SORIATANE	acitretin	CAPSULE;ORAL	019821-003	Aug 6, 2009		DISCN	Yes	No
Norvium Bioscience	ACITRETIN	acitretin	CAPSULE;ORAL	203707-002	Sep 10, 2015		DISCN	No	No
Teva Pharms Usa	ACITRETIN	acitretin	CAPSULE;ORAL	202897-001	Apr 4, 2013	AB	RX	No	No

Acitretin Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Acitretin

Introduction

Acitretin, a derivative of vitamin A, is a pharmaceutical agent primarily used in the treatment of severe psoriasis and other dermatological conditions. The market for acitretin is experiencing significant growth, driven by several key factors.

Market Size and Growth

As of 2023, the acitretin market was valued at approximately USD 33.8 million[1][3].

• The market is projected to grow at a Compound Annual Growth Rate (CAGR) of 4.6% from 2024 to 2032, reaching an estimated value of USD 50.4 million by 2032[1].
• Alternatively, some reports suggest a higher CAGR of 11.20%, predicting the market to reach USD 44.58 million by 2031[3].

Drivers of Market Growth

Increasing Prevalence of Psoriasis

The primary indication for acitretin is the treatment of severe psoriasis. The rising global prevalence of psoriasis, influenced by lifestyle changes, environmental factors, and genetic predisposition, is a major driver of the market[3].

Advancements in Psoriasis Treatment

Ongoing research and development in dermatology and autoimmune diseases may introduce new and improved treatment options, potentially increasing the adoption of acitretin if it demonstrates superior efficacy and safety compared to other treatments[3].

Increasing Awareness and Diagnosis

Greater awareness about psoriasis and its impact on patients' quality of life is leading to higher diagnosis rates. This increased awareness among healthcare professionals and patients is driving the demand for pharmacological interventions like acitretin[3].

Growing Investment in Healthcare Facilities

The surging focus on improving healthcare facilities and infrastructure, along with rising partnerships and strategic collaborations between public and private players, is fostering market growth[3].

Market Segmentation

Product Type

The acitretin market is segmented into branded and generic products. The generic segment dominates due to the growing demand for lower-cost generic drugs[1][3].

Dosage Strength

The market is bifurcated into 10 mg, 25 mg, and 50 mg dosage strengths. The 25 mg segment accounted for USD 16 million in 2023 and is expected to remain a significant segment[1].

Application

Acitretin is used in treating various conditions including psoriasis, ichthyosis, Darier disease, pityriasis rubra pilaris, solid organ transplants, Grover’s disease, lichen planus, and lupus erythematosus. The psoriasis segment is the largest and is estimated to account for USD 21.4 million by 2032[1].

Distribution Channel

The market is segmented into hospital pharmacies, retail pharmacies, and online pharmacies. Hospital pharmacies are expected to account for a significant share, estimated at USD 21.7 million by 2032[1].

Regional Analysis

North America

North America is expected to dominate the global acitretin market due to a strong base of healthcare facilities, the presence of major players, and increased research activities in the region[3].

Europe

Countries like Germany, the UK, and others in Europe are anticipated to experience significant growth in the acitretin market from 2024 to 2032[1].

Asia-Pacific

South Korea and other Asian countries are expected to grow substantially over the years, driven by improving healthcare infrastructure and increasing awareness of psoriasis[1].

Middle East and Africa

The UAE and other countries in the Middle East and Africa are anticipated to undergo substantial growth in the coming years[1].

Opportunities and Challenges

Expansion of Indications

Investigating and obtaining approvals for new indications of acitretin beyond its current use in severe psoriasis could present a significant opportunity for market expansion[3].

Growing Collaborations and Partnerships

Increasing partnerships and strategic collaborations between public and private players can further drive market growth by improving access to and the affordability of acitretin[3].

Challenges

Generic Competition

The dominance of generic products in the market can pose a challenge to branded acitretin, as generics are often preferred due to their lower cost[1][3].

Side Effects and Safety Concerns

Acitretin, like other retinoids, can have significant side effects, which may impact its adoption and market growth. Continuous monitoring and management of these side effects are crucial[2].

Financial Trajectory

• Revenue Projections: The market is expected to grow from USD 33.8 million in 2023 to USD 50.4 million by 2032 at a CAGR of 4.6%[1].
• Segmental Growth: The branded segment is estimated to account for USD 24.3 million by the end of 2032, while the hospital pharmacies segment is expected to reach USD 21.7 million by 2032[1].

Key Takeaways

• The acitretin market is driven by the increasing prevalence of psoriasis and advancements in treatment options.
• The market is segmented by product type, dosage strength, application, and distribution channel.
• North America and Europe are key regions driving market growth.
• Expansion of indications and growing collaborations are significant opportunities.
• Generic competition and side effects are notable challenges.

FAQs

Q: What is the primary use of acitretin? A: Acitretin is primarily used in the treatment of severe psoriasis, a chronic inflammatory skin disorder.

Q: What is the projected CAGR of the acitretin market from 2024 to 2032? A: The acitretin market is projected to grow at a CAGR of 4.6% from 2024 to 2032[1].

Q: Which segment dominates the acitretin market by product type? A: The generic segment dominates the acitretin market due to the growing demand for lower-cost generic drugs[1][3].

Q: What are the main distribution channels for acitretin? A: The main distribution channels are hospital pharmacies, retail pharmacies, and online pharmacies, with hospital pharmacies expected to account for a significant share[1].

Q: Which regions are expected to drive the growth of the acitretin market? A: North America, Europe, and the Asia-Pacific region are expected to drive the growth of the acitretin market[1][3].

Cited Sources

1. GMI Insights: Acitretin Market Size, Growth | Industry Outlook, 2024 – 2032
2. FDA: 214958Orig1s000 - accessdata.fda.gov
3. Data Bridge Market Research: Acitretin Market Size, Scope, Outlook & Trends Analysis By 2031
4. Medicaid: National Medicaid Fee-For-Service Drug Utilization Review
5. Market Research Intellect: Acitretin Capsules Market Size And Forecast