POMALIDOMIDE Drug Patent Profile

Which patents cover Pomalidomide, and when can generic versions of Pomalidomide launch?

Pomalidomide is a drug marketed by Apotex, Breckenridge, Eugia Pharma, Hetero Labs Ltd V, Mylan, and Teva Pharms Usa. and is included in six NDAs.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Pomalidomide

A generic version of POMALIDOMIDE was approved as pomalidomide by BRECKENRIDGE on October 30^th, 2020.

Summary for POMALIDOMIDE

US Patents:	0
Applicants:	6
NDAs:	6
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	116
Clinical Trials:	289
Patent Applications:	4,377
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for POMALIDOMIDE
DailyMed Link:	POMALIDOMIDE at DailyMed

Recent Clinical Trials for POMALIDOMIDE

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

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

See all POMALIDOMIDE clinical trials

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

POMALIDOMIDE is protected by zero US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Apotex	POMALIDOMIDE	pomalidomide	CAPSULE;ORAL	210164-001	Jun 11, 2024	AB	RX	No	No
Mylan	POMALIDOMIDE	pomalidomide	CAPSULE;ORAL	210275-002	Jan 26, 2022		DISCN	No	No
Teva Pharms Usa	POMALIDOMIDE	pomalidomide	CAPSULE;ORAL	209956-004	May 4, 2022	AB	RX	No	No
Breckenridge	POMALIDOMIDE	pomalidomide	CAPSULE;ORAL	210111-003	Oct 30, 2020	AB	RX	No	No
Apotex	POMALIDOMIDE	pomalidomide	CAPSULE;ORAL	210164-004	Jun 11, 2024	AB	RX	No	No

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

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.

---

References

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