POMALIDOMIDE - Generic Drug Details

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

Pomalidomide is the generic ingredient in two branded drugs marketed by Apotex, Breckenridge, Eugia Pharma, Hetero Labs Ltd V, Mylan, Teva Pharms Usa, and Bristol, and is included in seven NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Pomalidomide has fifty-three patent family members in thirty-three countries.

There are eleven drug master file entries for pomalidomide. Seven suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for POMALIDOMIDE

International Patents:	53
US Patents:	3
Tradenames:	2
Applicants:	7
NDAs:	7
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	116
Clinical Trials:	289
Patent Applications:	6,963
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for POMALIDOMIDE
What excipients (inactive ingredients) are in POMALIDOMIDE?	POMALIDOMIDE excipients list
DailyMed Link:	POMALIDOMIDE at DailyMed

Recent Clinical Trials for POMALIDOMIDE

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

Sponsor	Phase
Assistance Publique - Hpitaux de Paris	PHASE2
Bristol-Myers Squibb	PHASE2
Regeneron Pharmaceuticals	PHASE3

See all POMALIDOMIDE clinical trials

Generic filers with tentative approvals for POMALIDOMIDE

Applicant	Application No.	Strength	Dosage Form
		4MG	CAPSULE;ORAL
		3MG	CAPSULE;ORAL
		2MG	CAPSULE;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 POMALIDOMIDE

Drug Class

Thalidomide Analog

Anatomical Therapeutic Chemical (ATC) Classes for POMALIDOMIDE

L04AX	Other immunosuppressants
L04A	IMMUNOSUPPRESSANTS
L04	IMMUNOSUPPRESSANTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for POMALIDOMIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
POMALYST	Capsules	pomalidomide	1 mg, 2 mg, 3 mg and 4 mg	204026	6	2017-02-08

US Patents and Regulatory Information for POMALIDOMIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Pharms Usa	POMALIDOMIDE	pomalidomide	CAPSULE;ORAL	209956-001	May 4, 2022	AB	RX	No	No
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026-004	Feb 8, 2013	AB	RX	Yes	Yes	10,555,939*PED				Y
Mylan	POMALIDOMIDE	pomalidomide	CAPSULE;ORAL	210275-001	Jan 26, 2022		DISCN	No	No
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026-003	Feb 8, 2013	AB	RX	Yes	No	9,993,467*PED				Y
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026-002	Feb 8, 2013	AB	RX	Yes	No	9,993,467*PED				Y
Breckenridge	POMALIDOMIDE	pomalidomide	CAPSULE;ORAL	210111-004	Oct 30, 2020	AB	RX	No	No

Expired US Patents for POMALIDOMIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026-004	Feb 8, 2013	6,561,977
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026-003	Feb 8, 2013	6,476,052
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026-004	Feb 8, 2013	8,626,531
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026-004	Feb 8, 2013	8,158,653
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026-004	Feb 8, 2013	6,476,052
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026-003	Feb 8, 2013	8,589,188

EU/EMA Drug Approvals for POMALIDOMIDE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Bristol-Myers Squibb Pharma EEIG	Imnovid (previously Pomalidomide Celgene)	pomalidomide	EMEA/H/C/002682Imnovid in combination with bortezomib and dexamethasone is indicated in the treatment of adult patients with multiple myeloma who have received at least one prior treatment regimen including lenalidomide.Imnovid in combination with dexamethasone is indicated in the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy.	Authorised	no	no	no	2013-08-05

International Patents for POMALIDOMIDE

Country	Patent Number	Title	Estimated Expiration
Poland	2391355
Israel	214644	פורמולציות של 4-אמינו-2-(6,2-דיאוקסופיפרידין-3-איל)איזואינדולין-3,1-דיאון (Formulations of 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione)
European Patent Office	3351240
Ukraine	102582	ОРАЛЬНА ЛІКАРСЬКА ФОРМА 4-АМІНО-2-(2,6-ДІОКСОПІПЕРИДИН-3-ІЛ)ІЗОІНДОЛІН-1,3-ДІОНУ (ВАРІАНТИ)[ОРАЛЬНАЯ ЛЕКАРСТВЕННАЯ ФОРМА 4-АМИНО-2-(2,6-ДИОКСОПИПЕРИДИН-3-ИЛ)ИЗОИНДОЛИН-1,3-ДИОНА (ВАРИАНТЫ) (ORAL DOSAGE FORMS OF 4-AMINO-2-(2,6-DIOXOPIPERIDINE-3-YL)ISOINDOLINE-1,3-DIONE)
Peru	20120654
Portugal	3351240

Supplementary Protection Certificates for POMALIDOMIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2105135	1590004-6	Sweden		PRODUCT NAME: POMALIDOMIDE AND PHARMACEUTICALLY ACCEPTABLE SALTS, SOLVATES, HYDRATES OR STEREOISOMERS THEREOF; REG. NO/DATE: EU/1/13/850 20130808
2105135	300717	Netherlands		PRODUCT NAME: POMALIDOMIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN, SOLVATEN, HYDRATEN OF STEREOISOMEREN DAARVAN; REGISTRATION NO/DATE: EU/1/13/850 20130805
2105135	C300717	Netherlands		PRODUCT NAME: POMALIDOMIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN, SOLVATEN, HYDRATEN OF STEREOISOMEREN DAARVAN; REGISTRATION NO/DATE: EU/1/13/850 20130805
2105135	92642	Luxembourg		PRODUCT NAME: POMALIDOMIDE ET SES SELS, SOLVATES, HYDRATES OU STEREOISOMERES PHARMACEUTIQUEMENT ACCEPTABLES QUI EN DERIVENT (IMNOVID); FIRST REGISTRATION DATE: 20130805

POMALIDOMIDE Market Analysis and Financial Projection

Last updated: February 12, 2026

What are the current market dynamics for pomalidomide?

Pomalidomide, marketed under brand names such as Pomalyst, is an immunomodulatory agent primarily used to treat multiple myeloma. Developed by Celgene (now part of Bristol-Myers Squibb after 2019), its growth is influenced by several factors:

• Market size: The global multiple myeloma market was valued at approximately USD 19 billion in 2021 and is projected to grow at a compound annual growth rate (CAGR) of around 8% through 2030, driven by rising incidence rates and improved survival [1].

• Patient population: Multiple myeloma affects approximately 160,000 patients in the U.S. alone and around 250,000 worldwide. Pomalidomide is indicated for relapsed or refractory cases, representing a high-value segment within the broader myeloma therapy landscape.

• Competitive landscape: Pomalidomide faces competition from other immunomodulators including lenalidomide and thalidomide, as well as proteasome inhibitors like bortezomib. The introduction of newer agents such as daratumumab (a monoclonal antibody) impacts market share.

• Pricing and reimbursement: As of 2022, the average wholesale price of Pomalyst was approximately USD 15,000 per month. Insurance coverage and healthcare policies influence net revenue generation, especially across different regions.

• Regulatory approvals and patents: Pomalidomide received FDA approval in 2013. Patent expiry is anticipated around 2024-2026, with generics entering markets shortly afterward, potentially impacting pricing and revenues.

• Emerging research: The drug undergoes clinical trials exploring use in other hematologic malignancies, potentially expanding market applicability.

How does the financial trajectory look for pomalidomide?

Revenue Trends

• Historical revenue: In 2021, Bristol-Myers Squibb reported USD 1.7 billion in sales of Pomalyst globally, representing a plateauing trend following initial rapid growth from 2013 onwards.

• Projected revenue decline: As patent expiry approaches, analysts predict a decline, estimating a 30% reduction in sales by 2025 due to generic competition [2].

• Market share shifts: Pomalidomide’s share within the multiple myeloma market is approximately 15%, with competitors gradually capturing more of the segment.

Cost Dynamics

• Research and development: Additional investments funds clinical trials for expanded indications; these costs are substantial but offset by patent protections and market exclusivity for the duration.

• Manufacturing: Production costs are stable, with milestones expected around patent expiration and the release of generics.

Profitability Outlook

• Margins: Profit margins of branded pomalidomide are high, often exceeding 70%, owing to the specialized nature of the drug and patent protection.

• Post-patent implications: Generic entry could reduce prices by 50-70%, eroding profit margins and overall revenue.

Strategic Responses

• Lifecycle management: BMS and competitors pursue label expansions (e.g., new indications like myelofibrosis) to prolong revenue streams.

• Value-added formulations: Development of combination therapies involving pomalidomide can maintain market relevance.

What are the key factors influencing the drug’s future market and financial performance?

• Patent expiry timelines: Estimated around 2024-2026, critical for revenue forecasts.

• Emerging biosimilar products: Several biosimilars are in development, with potential early launches in 2024.

• Regulatory landscape: Approval of novel therapies for myeloma can suppress demand for existing agents.

• Pricing pressure: Payers increasingly seek negotiated discounts and value-based pricing schemes.

• Pipeline developments: Clinical trials indicating broader therapeutic potential could offset revenue declines.

Key Takeaways

• Pomalidomide is a significant drug within the multiple myeloma market, with revenues reaching USD 1.7 billion in 2021.

• Market fundamentals suggest steady growth until patent expiration, after which revenues are expected to decline sharply due to generics.

• Competitive, regulatory, and pricing pressures shape its financial outlook; strategic innovation and new indications aim to sustain revenue.

• The pharmaceutical landscape is transitioning toward biosimilar entry, intensifying pricing and market share competition.

• Investment and R&D decisions should consider patent timelines, pipeline developments, and emerging therapies.

FAQs

1. When will pomalidomide patents expire?
Patents are expected to expire around 2024-2026, with some patent extensions possibly prolonging exclusivity until 2027.

2. Are there any approved biosimilars for pomalidomide?
No. Biosimilars are typically developed for biologic drugs, and pomalidomide, being a small molecule, faces generic competition instead of biosimilars.

3. Can pomalidomide be used for other conditions?
Clinical trials are exploring usage in other hematologic malignancies, but current approvals focus solely on relapsed or refractory multiple myeloma.

4. How does development of new therapies impact pomalidomide?
Introduction of new, more effective agents or combination therapies could reduce demand for pomalidomide, especially if they offer improved safety, efficacy, or convenience.

5. What strategies are companies adopting to mitigate revenue decline?
Extending indications, developing combination formulations, engaging in lifecycle management, and preparing for biosimilar entry are primary strategies.

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References

[1] Market Research Future. (2022). "Multiple Myeloma Therapeutics Market."
[2] EvaluatePharma. (2022). "Global Oncology Drug Sales Analysis."