Apremilast - Generic Drug Details

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

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

Apremilast has one hundred and three patent family members in twenty-seven countries.

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

Summary for apremilast

International Patents:	103
US Patents:	8
Tradenames:	3
Applicants:	14
NDAs:	15
Drug Master File Entries:	28
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	85
Clinical Trials:	124
Patent Applications:	4,500
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
Yale University	PHASE2
National Institute on Alcohol Abuse and Alcoholism (NIAAA)	PHASE2
SFA Therapeutics	PHASE2

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
Unichem	APREMILAST	apremilast	TABLET;ORAL	211819-002	Feb 17, 2021		DISCN	No	No
Aurobindo Pharma Ltd	APREMILAST	apremilast	TABLET;ORAL	211716-001	Jul 19, 2023		DISCN	No	No
Teva Pharms Usa Inc	APREMILAST	apremilast	TABLET;ORAL	211897-003	Aug 18, 2022		DISCN	No	No
Amgen Inc	OTEZLA	apremilast	TABLET;ORAL	205437-003	Mar 21, 2014	AB	RX	Yes	Yes
Amgen Inc	OTEZLA	apremilast	TABLET;ORAL	205437-001	Mar 21, 2014	AB	RX	Yes	No	10,092,541*PED				Y
Macleods Pharms Ltd	APREMILAST	apremilast	TABLET;ORAL	211788-003	Nov 25, 2024		DISCN	No	No
Teva Pharms Usa Inc	APREMILAST	apremilast	TABLET;ORAL	211897-001	Aug 18, 2022		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	6,962,940
Amgen Inc	OTEZLA	apremilast	TABLET;ORAL	205437-001	Mar 21, 2014	8,802,717
Amgen Inc	OTEZLA	apremilast	TABLET;ORAL	205437-003	Mar 21, 2014	9,018,243
Amgen Inc	OTEZLA	apremilast	TABLET;ORAL	205437-001	Mar 21, 2014	6,020,358
Amgen Inc	OTEZLA	apremilast	TABLET;ORAL	205437-003	Mar 21, 2014	8,802,717
Amgen Inc	OTEZLA	apremilast	TABLET;ORAL	205437-001	Mar 21, 2014	9,018,243
Amgen Inc	OTEZLA	apremilast	TABLET;ORAL	205437-003	Mar 21, 2014	6,020,358

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/003746Psoriatic 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
China	1965823	Preparing methods of (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4 acetylaminoisoindoline 1,3-dione and its compound
Hungary	E045489
South Africa	200600682	(+)-2[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione: Methods of using and compositions thereof
Canada	3216640	FORMULATIONS D'APREMILAST (FORMULATIONS OF APREMILAST)
South Korea	101104991
New Zealand	535798	(+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione: methods of using and compositions thereof
South Korea	20150126618	아프레밀라스트를 사용하는 건선성 관절염의 치료 (TREATMENT OF PSORIATIC ARTHRITIS USING APREMILAST)

Supplementary Protection Certificates for apremilast

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2962690	37/2019	Austria		PRODUCT NAME: APREMILAST ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/14/981 (MITTEILUNG) 20150116
2962690	LUC00125	Luxembourg		PRODUCT NAME: APREMILAST, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; AUTHORISATION NUMBER AND DATE: EU/1/14/981 20150116
2962690	C201930044	Spain		PRODUCT NAME: APREMILAST O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/14/981; DATE OF AUTHORISATION: 20150115; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/981; DATE OF FIRST AUTHORISATION IN EEA: 20150115
2962690	122019000070	Germany		PRODUCT NAME: APREMILAST ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/14/981 20150115
2962690	365 14-2019	Slovakia		PRODUCT NAME: APREMILAST VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/14/981 20150116
2962690	C 2019 032	Romania		PRODUCT NAME: APREMILAST SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/14/981; DATE OF NATIONAL AUTHORISATION: 20150115; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/981; DATE OF FIRST AUTHORISATION IN EEA: 20150115
2962690	SPC/GB19/045	United Kingdom		PRODUCT NAME: APREMILAST, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/14/981/001(NI) 20150116; UK EU/1/14/981/002(NI) 20150116; UK EU/1/14/981/003(NI) 20150116; UK PLGB 50412/0006 20150116; UK PLGB 50412/0007 20150116

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Apremilast

Last updated: July 27, 2025

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Introduction

Apremilast, marketed under the brand name Otezla, is an oral phosphodiesterase 4 (PDE4) inhibitor developed by Celgene (now part of Bristol-Myers Squibb). Primarily approved for treating moderate to severe plaque psoriasis, psoriatic arthritis, and oral ulcers associated with Behçet’s disease, apremilast has established a significant footprint within the niche of immunomodulatory therapies. This analysis explores the evolving market landscape, competitive positioning, and financial trajectory forecast for apremilast, providing strategic insights for industry stakeholders.

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Market Overview

The global psoriasis drug market, into which apremilast primarily falls, was valued at approximately USD 4.5 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of around 8% through 2030, driven by increasing prevalence, unmet needs, and expanding approval of novel agents ([1]). Psoriasis affects around 125 million globally, with a subset requiring systemic or biologic therapy, thus creating steady demand.

Key Indications and Market Penetration

• Plaque Psoriasis: Constitutes the majority of apremilast's prescriptions due to its oral administration advantage over injectable biologics.
• Psoriatic Arthritis (PsA): Represented a second significant indication, complementing psoriasis treatment.
• Oral Ulcers in Behçet’s Disease: An off-label but growing niche.

Competitive Landscape

Apremilast competes chiefly with biologics such as adalimumab, ustekinumab, secukinumab, and emerging oral agents like risankizumab. The competitive edge relies on administration route, safety profile, and reimbursement factors. Orally administered drugs like apremilast appeal for their convenience and perceived safety, but biologics offer higher efficacy in some severe cases.

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Market Dynamics Influencing Apremilast

1. Evolving Treatment Paradigms

• Shift to Biologics and Biosimilars: Biologics dominate moderate-to-severe psoriasis treatments but face patent expirations, prompting shifts towards biosimilars and oral small molecules.
• Emergence of Novel Oral Agents: Janus kinase (JAK) inhibitors and phosphodiesterase 4 inhibitors like apremilast balance efficacy with safety, impacting market share.

2. Regulatory and Approval Trends

• Apremilast has received various approvals across markets—USD 6 billion in global sales in 2022 ([2]), with recent approvals for new indications and formulations in select countries fueling growth.
• Regulatory authorities are emphasizing safety profiles, especially cardiovascular and psychiatric risks, influencing prescribing behavior.

3. Price and Reimbursement Dynamics

• Price pressures, especially in mature markets like the US, Europe, and Japan, are influencing revenue. Payers favor cost-effective oral therapies, provided efficacy benchmarks meet standards.
• Reimbursement policies, including value-based pricing, impact market access.

4. Patent and Exclusivity

• Patents on Otezla remain valid till approximately 2028-2029; after expiration, biosimilar competition may erode revenues.

5. Impact of COVID-19

• Pandemic-related disruptions initially decreased new prescriptions but later spurred demand for convenient oral therapies, favoring apremilast.

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Financial Trajectory and Revenue Projections

Historical Performance

Bristol-Myers Squibb reported apremilast sales of around USD 6.3 billion in 2022, effectively making it a mid-tier franchise. The growth trajectory was stabilized by solid market penetration and expanding indications.

Forecasted Trends

• Short-term (2023-2025): Growth expected to stabilize at 4-6% CAGR due to market saturation in established countries and steady approval of new indications. Renewed emphasis on combination therapy and expanded use in off-label indications could marginally boost revenues.
• Medium to Long-term (2026-2030): As patent exclusivity diminishes, revenues could decline unless offset by biosimilar competition or new formulations. Nonetheless, strategic pipeline expansion and brand loyalty may sustain revenues around USD 6-7 billion annually until 2030.

Key Factors Affecting Financial Outlook

• Patent Cliff: Predicted expiry around 2028 poses significant risk. Potential biosimilar entry may cut revenues by 30-50%, similar to other biologic and targeted small molecule transitions.
• Pipeline and Line Extensions: Development of formulations such as topical, injectable combinations, or biomarkers for personalized therapy can foster future growth.
• Emerging Markets: Rapid growth in Asia-Pacific and Latin America —expected CAGR of 10%— offers revenue expansion opportunities.
• Cost-Effectiveness and Reimbursement Policies: Cost containment pressures threaten margins but also incentivize demonstrating value through health economics.

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Strategic Considerations

• Investment in Pipeline Innovation: Developing next-generation PDE4 inhibitors or combining apremilast with biologics could extend market relevance.
• Market Expansion: Securing approvals for additional indications and broader geographies will sustain revenue streams.
• Lifecycle Management: Leveraging patents and exclusive rights while preparing for biosimilar transition is critical.
• Digital and Patient-Centric Approaches: Integrating digital health tools and real-world evidence can enhance market positioning and demonstrate long-term value.

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Conclusion

Apremilast stands at a pivotal juncture in its lifecycle, balancing its established market position against the impending patent expiry and intensifying competition. Its financial trajectory will hinge on effective lifecycle management, pipeline development, and strategic market expansion. The drug’s ongoing success will depend on adapting to evolving treatment paradigms and healthcare policies emphasizing safety, efficacy, and cost-efficiency.

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Key Takeaways

• Apremilast's stronghold in oral immunomodulatory therapy offers resilience amid biologic competition but faces patent expiry risks post-2028.
• Market growth will rely on expanding indications, geographic penetration, and innovative formulations.
• Cost containment and reimbursement landscape are vital factors influencing future revenues.
• Biosimilar entry and emerging oral therapies may pressure sales but also open partnership and licensing avenues.
• Strategic pipeline investments and digital health integration will be critical for maintaining market relevance.

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FAQs

1. When will apremilast’s patent protection expire?
Patents for Otezla are expected to expire around 2028-2029, after which biosimilar competition could significantly impact market share.

2. How does apremilast compare with biologics in efficacy?
While biologics generally demonstrate higher efficacy in severe cases, apremilast offers a convenient oral route with a favorable safety profile, making it suitable for moderate disease or patients preferring oral therapy.

3. What are the key risks facing apremilast’s market longevity?
Patent expiration, biosimilar competition, safety concerns, and pricing pressures in payers’ reimbursement policies pose significant risks.

4. Are there new indications or formulations in development?
Celgene/BMS continues to explore new formulations and off-label applications, aiming to extend its therapeutic scope and lifecycle.

5. How is market growth influenced by emerging markets?
High growth potential exists in Asia-Pacific and Latin America, driven by increasing disease prevalence and rising healthcare investments.

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Sources

[1] Grand View Research, "Psoriasis Drugs Market Size, Share & Trends Analysis Report," 2023.
[2] Bristol-Myers Squibb Annual Report, 2022.