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Last Updated: December 22, 2024

APREMILAST Drug Patent Profile


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

Apremilast is a drug marketed by Alkem Labs Ltd, Amneal, Annora, Aurobindo Pharma Ltd, Dr Reddys, Glenmark Pharms Ltd, Mankind Pharma, Shilpa, Teva Pharms Usa Inc, and Unichem. and is included in ten NDAs.

The generic ingredient in APREMILAST is apremilast. There are twenty-eight drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the apremilast profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Apremilast

A generic version of APREMILAST was approved as apremilast by ALKEM LABS LTD on September 21st, 2021.

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Drug patent expirations by year for APREMILAST
Recent Clinical Trials for APREMILAST

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

SponsorPhase
TakedaPhase 3
Assiut UniversityPhase 1
Humanis Saglık Anonim SirketiPhase 3

See all APREMILAST clinical trials

Paragraph IV (Patent) Challenges for APREMILAST
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
OTEZLA Tablets apremilast 10 mg, 20 mg and 30 mg 205437 11 2018-03-22

US Patents and Regulatory Information for APREMILAST

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Unichem APREMILAST apremilast TABLET;ORAL 211819-001 Feb 17, 2021 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Unichem APREMILAST apremilast TABLET;ORAL 211819-002 Feb 17, 2021 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Alkem Labs Ltd APREMILAST apremilast TABLET;ORAL 211761-001 Sep 21, 2021 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Glenmark Pharms Ltd APREMILAST apremilast TABLET;ORAL 211674-003 Oct 16, 2023 AB RX No 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

EU/EMA Drug Approvals for APREMILAST

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Amgen Europe BV Otezla apremilast EMEA/H/C/003746
Psoriatic arthritisOtezla, alone or in combination with Disease Modifying Antirheumatic Drugs (DMARDs), is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior DMARD therapy.PsoriasisOtezla is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen and ultraviolet-A light (PUVA).
Authorised no no no 2015-01-15
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

APREMILAST Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Apremilast

Market Overview

Apremilast, marketed under the brand name Otezla, is a pharmaceutical drug used primarily for the treatment of psoriatic arthritis, plaque psoriasis, and other related conditions. The market for apremilast is experiencing significant growth, driven by several key factors.

Growth Drivers

Increasing Prevalence of Arthritis and Psoriasis

The rise in the prevalence of arthritis and psoriasis is a major driver of the apremilast market. As these conditions become more common, the demand for effective treatments like apremilast increases, contributing to market growth[1][4].

Rising Healthcare Expenditure

Increased healthcare expenditure globally is another significant factor. Countries with well-developed healthcare infrastructures, such as those in North America, are particularly driving this growth due to higher disposable incomes and better access to healthcare services[1].

Geriatric Population and Clinical Trials

The growing geriatric population and the upsurge in clinical trial studies are also boosting the market. Older populations are more prone to chronic conditions like psoriatic arthritis, and ongoing clinical trials are expanding the potential applications of apremilast[1].

Government Initiatives and Awareness

Government initiatives and rising awareness about psoriasis and psoriatic arthritis are further enhancing market growth. These factors encourage more patients to seek medical treatment, thereby increasing the demand for apremilast[1].

Market Segmentation

By Strength and Dosage Form

The apremilast market is segmented by strength (10mg, 20mg, 30mg) and dosage form (tablets, others). These segments help in analyzing the market from different perspectives, such as patient compliance and treatment efficacy[1].

By Application

Apremilast is used for various applications, including psoriasis, psoriatic arthritis, and other conditions. The market growth in these segments is driven by the specific needs of each patient population[1][4].

By End-Users and Distribution Channel

The market is also segmented by end-users (clinics, hospitals, others) and distribution channels (hospital pharmacy, retail pharmacy, online pharmacy). Understanding these segments is crucial for marketing strategies and distribution logistics[1][4].

Geographical Analysis

North America

North America dominates the apremilast market due to the presence of major key players, high disposable income, and well-developed healthcare infrastructure. This region is expected to continue driving market growth[1].

Asia-Pacific

The Asia-Pacific region is expected to grow significantly during the forecast period due to increasing research and development activities and rising government support. Countries like China, Japan, and India are key contributors to this growth[1].

Financial Trajectory

Market Size and CAGR

The global apremilast market is projected to reach USD 3.41 billion by 2029, growing at a Compound Annual Growth Rate (CAGR) of 5% from 2022 to 2029. By 2032, the market is expected to be valued at approximately USD 3.5 billion, with a CAGR of 5.25% from 2024 to 2032[1][4].

Revenue Growth

The revenue growth of the apremilast market is driven by increasing demand from various end-use industries, rising disposable income, and rapid urbanization. These factors are expected to escalate the market growth rate in the forecast period[1].

Challenges and Restraints

High Cost and Side Effects

Despite the growth, the apremilast market faces challenges such as the high cost associated with the product and side effects like nausea, diarrhea, vomiting, and dizziness. These factors can hamper market growth and affect patient compliance[1].

Lack of Awareness

Lack of awareness about the treatment options for psoriasis and psoriatic arthritis is another challenge. Educating patients and healthcare providers about the benefits of apremilast is crucial to overcome this barrier[1].

Competitive Landscape

Key Players

The competitive landscape of the apremilast market includes major players like Amgen, which recently received FDA approval for Otezla for the treatment of moderate to severe plaque psoriasis in children and adolescents. Other companies are also investing heavily in research and development to expand their market share[1][3].

Company Profiles and Market Share

The market report provides detailed profiles of key players, including their company overview, financials, market potential, and investment in research and development. This information helps in understanding the competitive dynamics and market share distribution[1].

Recent Developments

FDA Approval for Pediatric Use

A significant recent development is the FDA approval of Otezla for the treatment of moderate to severe plaque psoriasis in children and adolescents ages 6 and older. This approval opens up a new patient population for apremilast, further expanding its market potential[3].

Economic and Cost-Effectiveness Analysis

Cost-Effectiveness Ratio

Studies by the National Institute for Health and Care Excellence (NICE) have evaluated the cost-effectiveness of apremilast. The analysis indicates that while apremilast may be less effective than some other treatments, it is cost-effective, particularly when used in treatment sequences after other therapies[5].

Key Takeaways

  • The apremilast market is driven by increasing prevalence of arthritis and psoriasis, rising healthcare expenditure, and growing geriatric population.
  • The market is segmented by strength, dosage form, application, end-users, and distribution channels.
  • North America and Asia-Pacific are key regions driving market growth.
  • The market is expected to reach USD 3.41 billion by 2029 and USD 3.5 billion by 2032.
  • High cost and side effects are significant challenges, while lack of awareness is another barrier.
  • Recent FDA approvals for pediatric use are expanding the market potential.

FAQs

1. What are the primary applications of apremilast?

Apremilast is primarily used for the treatment of psoriatic arthritis, plaque psoriasis, and other related conditions.

2. Which region dominates the apremilast market?

North America dominates the apremilast market due to the presence of major key players, high disposable income, and well-developed healthcare infrastructure.

3. What is the expected CAGR of the apremilast market from 2024 to 2032?

The anticipated CAGR for the apremilast market from 2024 to 2032 is 5.25%.

4. What are the major challenges facing the apremilast market?

The major challenges include the high cost associated with the product and side effects like nausea, diarrhea, vomiting, and dizziness, as well as a lack of awareness about the treatment options.

5. Has apremilast been approved for pediatric use?

Yes, Otezla (apremilast) has been approved by the FDA for the treatment of moderate to severe plaque psoriasis in children and adolescents ages 6 and older.

Sources:

  1. Data Bridge Market Research - Global Apremilast Market - Industry Trends and Forecast to 2029
  2. Market Research Intellect - Global Apremilast API Market Size, Scope And Forecast Report
  3. PR Newswire - OTEZLA® (APREMILAST) NOW AVAILABLE IN THE U.S. FOR MODERATE TO SEVERE PEDIATRIC PLAQUE PSORIASIS
  4. Market Research Future - Apremilast Market Size, Growth, Trends, Report 2032
  5. NICE - Apremilast for treating active psoriatic arthritis - Final appraisal determination document

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