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Last Updated: December 22, 2024

SORIATANE Drug Patent Profile


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When do Soriatane patents expire, and when can generic versions of Soriatane launch?

Soriatane is a drug marketed by Stiefel Labs Inc and is included in one NDA.

The generic ingredient in SORIATANE is acitretin. There are eleven drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the acitretin profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Soriatane

A generic version of SORIATANE was approved as acitretin by BARR LABS INC on April 4th, 2013.

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Summary for SORIATANE
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 119
Clinical Trials: 5
Patent Applications: 5,460
Drug Prices: Drug price information for SORIATANE
What excipients (inactive ingredients) are in SORIATANE?SORIATANE excipients list
DailyMed Link:SORIATANE at DailyMed
Drug patent expirations by year for SORIATANE
Drug Prices for SORIATANE

See drug prices for SORIATANE

Recent Clinical Trials for SORIATANE

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

SponsorPhase
Tulane UniversityPhase 2
Assistance Publique - Hôpitaux de ParisPhase 2
University of ArizonaPhase 2

See all SORIATANE clinical trials

US Patents and Regulatory Information for SORIATANE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Stiefel Labs Inc SORIATANE acitretin CAPSULE;ORAL 019821-001 Oct 28, 1996 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Stiefel Labs Inc SORIATANE acitretin CAPSULE;ORAL 019821-002 Oct 28, 1996 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Stiefel Labs Inc SORIATANE acitretin CAPSULE;ORAL 019821-003 Aug 6, 2009 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Stiefel Labs Inc SORIATANE acitretin CAPSULE;ORAL 019821-004 Aug 6, 2009 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

SORIATANE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for SORIATANE (Acitretin)

Overview of SORIATANE (Acitretin)

SORIATANE, known generically as acitretin, is a second-generation retinoid used primarily for the treatment of severe psoriasis and other skin disorders. Here, we delve into the market dynamics and financial trajectory of this drug.

Market Size and Growth

The global acitretin market was valued at approximately USD 33.8 million in 2023 and 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].

Segmentation of the Acitretin Market

Product Type

The market is segmented into branded and generic versions. The branded segment is expected to account for USD 24.3 million by the end of 2032, while generics are gaining traction due to their cost-effectiveness[1].

Dosage Strength

Acitretin is available in 10 mg, 25 mg, and 50 mg dosages. The 25 mg segment was the largest in 2023, accounting for USD 16 million[1].

Application

The primary indication for acitretin is the treatment of severe psoriasis, but it is also used for other conditions such as ichthyosis, Darier disease, pityriasis rubra pilaris, and lupus erythematosus. The psoriasis segment is expected to dominate, projected 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 anticipated to account for USD 21.7 million by 2032[1].

Drivers of Market Growth

Increasing Prevalence of Psoriasis

The rising global prevalence of psoriasis, driven by lifestyle changes, environmental factors, and genetic predisposition, is a significant driver for the demand of acitretin[4].

Advancements in Psoriasis Treatment

Ongoing research and development in dermatology and autoimmune diseases may lead to new and improved treatment options, potentially increasing the adoption of acitretin if it demonstrates superior efficacy and safety[4].

Increasing Awareness and Diagnosis

Greater awareness about psoriasis and its impact on quality of life is leading to higher diagnosis rates, which in turn increases the demand for pharmacological interventions like acitretin[4].

Growing Investment in Healthcare Facilities

Improvements in healthcare infrastructure and the increasing number of partnerships between public and private players are fostering market growth[4].

Opportunities

Expansion of Indications

Investigating and obtaining approvals for new indications beyond severe psoriasis could significantly expand the market for acitretin. Clinical trials exploring its efficacy in related dermatological conditions or autoimmune disorders could open up new markets[4].

Growing Collaborations and Partnerships

Strategic collaborations and partnerships, especially in the context of funding and applying new technologies, are creating lucrative opportunities for the acitretin market[4].

Challenges

Side Effects and Safety Concerns

Acitretin is associated with several side effects, including mucocutaneous effects, teratogenicity, and lipid metabolism abnormalities. These safety concerns may limit its use, particularly in certain patient populations, and require careful monitoring[3][4].

Availability of Alternative Therapies

The presence of alternative therapies for psoriasis and other skin conditions poses a challenge to the widespread adoption of acitretin. Patients and healthcare providers may opt for other treatment options with fewer side effects or more favorable safety profiles[4].

Regional Analysis

North America

North America is expected to dominate the global acitretin market due to the strong base of healthcare facilities, the presence of major players, and the rising number of research activities in this region[4].

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 countries in the Asia-Pacific region are expected to grow significantly over the forecast period[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].

Financial Trajectory

Revenue Projections

The acitretin market is projected to grow from USD 33.8 million in 2023 to USD 50.4 million by 2032, with a CAGR of 4.6% during the forecast period[1].

Segment Performance

  • Branded Segment: Expected to account for USD 24.3 million by 2032[1].
  • Psoriasis Segment: Projected to account for USD 21.4 million by 2032[1].
  • Hospital Pharmacies: Anticipated to account for USD 21.7 million by 2032[1].

Key Takeaways

  • The global acitretin market is driven by the increasing prevalence of psoriasis and advancements in treatment options.
  • Safety concerns and the availability of alternative therapies are significant challenges.
  • North America is expected to dominate the market, with substantial growth anticipated in Europe, Asia-Pacific, and the Middle East and Africa.
  • The market is segmented into branded and generic versions, with generics gaining traction.

FAQs

What is the primary indication for acitretin?

The primary indication for acitretin is the treatment of severe psoriasis.

What are the common side effects associated with acitretin?

Common side effects include mucocutaneous effects, teratogenicity, and lipid metabolism abnormalities.

Which region is expected to dominate the global acitretin market?

North America is expected to dominate the global acitretin market due to its strong healthcare infrastructure and research activities.

What is the projected CAGR for the acitretin market from 2024 to 2032?

The acitretin market is projected to grow at a CAGR of 4.6% from 2024 to 2032.

What are the potential opportunities for expanding the acitretin market?

Investigating new indications beyond severe psoriasis and growing collaborations and partnerships are significant opportunities for market expansion.

Sources

  1. GMI Insights: Acitretin Market Size, Growth | Industry Outlook, 2024 – 2032
  2. Annual Reports: 2020 Annual Report
  3. FDA: SORIATANE® - accessdata.fda.gov
  4. Data Bridge Market Research: Global Acitretin Market Size, Scope, Outlook & Trends Analysis By 2031
  5. GSK: 2013 Results Announcement

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