APREMILAST - Generic Drug Details

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

Apremilast is the generic ingredient in two branded drugs marketed by Alkem Labs Ltd, Amneal, Annora, Aurobindo Pharma Ltd, Dr Reddys, Glenmark Pharms Ltd, Mankind Pharma, Shilpa, Teva Pharms Usa Inc, Unichem, and Amgen Inc, and is included in eleven NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Apremilast has ninety patent family members in twenty-four countries.

There are twenty-eight drug master file entries for apremilast. One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for APREMILAST

International Patents:	90
US Patents:	3
Tradenames:	2
Applicants:	11
NDAs:	11
Drug Master File Entries:	28
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	86
Clinical Trials:	116
Patent Applications:	1,657
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for APREMILAST
What excipients (inactive ingredients) are in APREMILAST?	APREMILAST excipients list
DailyMed Link:	APREMILAST at DailyMed

Recent Clinical Trials for APREMILAST

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

Sponsor	Phase
Takeda	Phase 3
Assiut University	Phase 1
Humanis Saglık Anonim Sirketi	Phase 3

See all APREMILAST clinical trials

Generic filers with tentative approvals for APREMILAST

Applicant	Application No.	Strength	Dosage Form
		30MG	TABLET;ORAL
		20MG	TABLET;ORAL
		10MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for APREMILAST

Drug Class	Phosphodiesterase 4 Inhibitor
Mechanism of Action	Phosphodiesterase 4 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for APREMILAST

L04AA	Selective immunosuppressants
L04A	IMMUNOSUPPRESSANTS
L04	IMMUNOSUPPRESSANTS
L	Antineoplastic and immunomodulating agents

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
Dr Reddys	APREMILAST	apremilast	TABLET;ORAL	211756-003	Jul 14, 2023		DISCN	No	No
Dr Reddys	APREMILAST	apremilast	TABLET;ORAL	211756-002	Jul 14, 2023		DISCN	No	No
Amneal	APREMILAST	apremilast	TABLET;ORAL	211782-001	Jun 30, 2021		DISCN	No	No
Mankind Pharma	APREMILAST	apremilast	TABLET;ORAL	211734-003	Feb 7, 2024	AB	RX	No	No
Dr Reddys	APREMILAST	apremilast	TABLET;ORAL	211756-001	Jul 14, 2023		DISCN	No	No

Expired US Patents for APREMILAST

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Amgen Inc	OTEZLA	apremilast	TABLET;ORAL	205437-003	Mar 21, 2014
Amgen Inc	OTEZLA	apremilast	TABLET;ORAL	205437-002	Mar 21, 2014
Amgen Inc	OTEZLA	apremilast	TABLET;ORAL	205437-002	Mar 21, 2014
Amgen Inc	OTEZLA	apremilast	TABLET;ORAL	205437-002	Mar 21, 2014
Amgen Inc	OTEZLA	apremilast	TABLET;ORAL	205437-003	Mar 21, 2014

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

International Patents for APREMILAST

Country	Patent Number	Title	Estimated Expiration
Cyprus	1119204
Hong Kong	1215671	利用阿普斯特來治療銀屑病關節炎的方法 (TREATMENT OF PSORIATIC ARTHRITIS USING APREMILAST)
Slovenia	2223687
South Korea	20050012722
Japan	2015013893	（＋）−２−［１−（３−エトキシ−４−メトキシフェニル）−２−メチルスルホニルエチル］−４−アセチルアミノイソインドリン−１，３−ジオン、その使用方法及び組成物 ((+)-2-[1-(3-ETHOXY-4-METHOXYPHENYL)-2-METHYLSULFONYLETHYL]-4-ACETYLAMINOISOINDOLINE-1,3-DIONE, METHODS OF USING THE SAME, AND COMPOSITIONS)

Supplementary Protection Certificates for APREMILAST

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2962690	CR 2019 00033	Denmark		PRODUCT NAME: APREMILAST ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/14/981 20150116
2962690	C02962690/01	Switzerland		VERTRETERLOESCHUNG
2962690	CA 2019 00033	Denmark		PRODUCT NAME: APREMILAST ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/14/981 20150116
2962690	365 14-2019	Slovakia		PRODUCT NAME: APREMILAST VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/14/981 20150116
2962690	2019C/008	Belgium		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CESSION

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