POMALYST Drug Patent Profile

When do Pomalyst patents expire, and what generic alternatives are available?

Pomalyst is a drug marketed by Bristol and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-three patent family members in thirty-three countries.

The generic ingredient in POMALYST 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 Pomalyst

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

Summary for POMALYST

International Patents:	53
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	116
Clinical Trials:	83
Patent Applications:	4,377
Drug Prices:	Drug price information for POMALYST
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for POMALYST
What excipients (inactive ingredients) are in POMALYST?	POMALYST excipients list
DailyMed Link:	POMALYST at DailyMed

See drug prices for POMALYST

Recent Clinical Trials for POMALYST

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

Sponsor	Phase
Megalabs	Phase 1
University of Chicago	Phase 2
Regeneron Pharmaceuticals	Phase 3

See all POMALYST clinical trials

Pharmacology for POMALYST

Drug Class

Thalidomide Analog

Paragraph IV (Patent) Challenges for POMALYST

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 POMALYST

POMALYST is protected by three US patents and three FDA Regulatory Exclusivities.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026-001	Feb 8, 2013	AB	RX	Yes	No					Y
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026-003	Feb 8, 2013	AB	RX	Yes	No
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026-004	Feb 8, 2013	AB	RX	Yes	Yes					Y
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026-001	Feb 8, 2013	AB	RX	Yes	No
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026-003	Feb 8, 2013	AB	RX	Yes	No

Expired US Patents for POMALYST

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026-004	Feb 8, 2013
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026-003	Feb 8, 2013
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026-004	Feb 8, 2013
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026-004	Feb 8, 2013
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026-004	Feb 8, 2013

EU/EMA Drug Approvals for POMALYST

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 POMALYST

See the table below for patents covering POMALYST around the world.

Country	Patent Number	Title	Estimated Expiration
Brazil	PI0616670	uso de 3-(4-amino-1-oxo-1,3-diidro-isoindol-2-il)-piperidina-2,6- diona, e, uso do mesmo e de um agente ativo secundário
New Zealand	540385	Use of 1-oxo-2-(2, 6-dioxopiperidin-3-yl)-4-methylisoindoline in the manufacture of a medicamnent for treatment of brain cancer
European Patent Office	2561874	Compositions pharmaceutiques pour le traitement du cancer (Pharmaceutical compositions for treating cancer)
Norway	341035
Israel	241949

Supplementary Protection Certificates for POMALYST

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2105135	5/2015	Austria		PRODUCT NAME: POMALIDOMID UND SEINE PHARMAZEUTISCH AKZEPTABLEN SALZE, SOLVATE, HYDRATE ODER STEREOISOMERE; REGISTRATION NO/DATE: EU/1/13/850 20130805
2105135	1590004-6	Sweden		PRODUCT NAME: POMALIDOMIDE AND PHARMACEUTICALLY ACCEPTABLE SALTS, SOLVATES, HYDRATES OR STEREOISOMERS THEREOF; REG. NO/DATE: EU/1/13/850 20130808
0925294	91359	Luxembourg		91359, EXPIRES: 20220614
2105135	212 50002-2015	Slovakia		PRODUCT NAME: POMALIDOMID; REGISTRATION NO/DATE: EU/1/13/850/001 - EU/1/13/850/004 20130808
2105135	C300717	Netherlands		PRODUCT NAME: POMALIDOMIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN, SOLVATEN, HYDRATEN OF STEREOISOMEREN DAARVAN; REGISTRATION NO/DATE: EU/1/13/850 20130805

Pomalyst: Market Dynamics and Financial Trajectory Analysis

Last updated: February 19, 2026

Pomalyst (pomalidomide) is a prescription medication used to treat multiple myeloma, a type of blood cancer, and Kaposi sarcoma. Its market performance is influenced by patent exclusivity, clinical trial outcomes, regulatory approvals, and competitive landscapes. The drug’s primary mechanism of action involves immunomodulatory, anti-angiogenic, and direct anti-tumor effects.

What is the Current Market Position of Pomalyst?

Pomalyst holds a significant position in the multiple myeloma treatment landscape. It is approved for patients with relapsed or refractory multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor, and who have demonstrated disease progression on or after the last therapy. It is also approved for Kaposi sarcoma.

Key market drivers include:

• Incidence and Prevalence of Multiple Myeloma: The rising incidence and aging global population contribute to an expanding patient pool requiring treatment. In 2023, the American Cancer Society estimated 35,730 new cases of multiple myeloma in the U.S. [1].
• Therapeutic Efficacy and Safety Profile: Pomalyst has demonstrated clinical efficacy in heavily pre-treated patient populations, offering a valuable treatment option when other therapies fail.
• Patent Exclusivity and Generic Entry: The expiration of primary patents for Pomalyst is a critical factor influencing its future market dynamics. Generic competition typically leads to significant price erosion and market share shifts.

What are the Key Patents Protecting Pomalyst?

The patent portfolio for Pomalyst is multifaceted, encompassing compound patents, formulation patents, and method of use patents. The primary compound patent for pomalidomide is nearing expiration, opening the door for generic development.

• Core Compound Patent: U.S. Patent No. 7,723,324, covering the compound pomalidomide, has been a cornerstone of Pomalyst's exclusivity. This patent was initially set to expire, but has been subject to various challenges and extensions.
• Formulation and Method of Use Patents: Additional patents cover specific formulations and methods of administering Pomalyst, which can extend market exclusivity for certain applications or delivery mechanisms. These patents are often subject to litigation.

The landscape of patent litigation significantly impacts the commercial life of the drug. Challenges to patent validity and assertions of non-infringement by generic manufacturers are common. The outcomes of these legal battles directly determine the timeline for generic market entry.

What is the Competitive Landscape for Pomalyst?

Pomalyst operates within a highly competitive market for multiple myeloma treatments. Its competitors include both other immunomodulatory drugs (IMiDs), proteasome inhibitors, monoclonal antibodies, and emerging cell therapies.

Major competitors and therapeutic classes include:

• Other IMiDs: Lenalidomide (Revlimid) is a predecessor and closely related drug, also facing generic competition.
• Proteasome Inhibitors: Bortezomib (Velcade), carfilzomib (Kyprolis), and ixazomib (Ninlaro) are standard-of-care treatments used in various lines of therapy.
• Monoclonal Antibodies: Daratumumab (Darzalex), isatuximab (Sarclisa), and elotuzumab (Empliciti) target CD38 or SLAMF7, respectively, and are integrated into multiple myeloma treatment regimens.
• BCL-2 Inhibitors: Venetoclax (Venclexta), in combination with other agents, shows efficacy in specific patient subsets, particularly those with t(11;14) translocation.
• CAR T-Cell Therapies: Idecabtagene vicleucel (Abecma) and ciltacabtagene autoleucel (Carvykti) represent a significant advancement, offering deep and durable responses in relapsed/refractory settings.

The introduction of CAR T-cell therapies, in particular, has altered the treatment paradigm for relapsed and refractory multiple myeloma, potentially impacting the market share of older therapies like Pomalyst in later lines of treatment.

What are the Financial Performance Metrics for Pomalyst?

Bristol Myers Squibb (BMS), the marketer of Pomalyst, reports substantial revenue from the drug. Its financial trajectory is indicative of its market penetration and pricing power.

Historical Revenue Performance (USD Millions):

Year	Pomalyst Revenue
2021	2,376
2022	2,455
2023	2,202

Note: 2023 revenue reflects the impact of initial generic competition in some markets [2].

Key financial considerations:

• Revenue Growth: Prior to significant generic entry, Pomalyst experienced consistent revenue growth, driven by its established efficacy and inclusion in treatment guidelines.
• Impact of Generic Entry: The introduction of generic pomalidomide in 2024 is projected to cause a substantial decline in Pomalyst sales. Estimates suggest a revenue drop of over 70% in the first year of generic competition.
• Pricing: Pomalyst commands a premium price due to its therapeutic value and R&D investment. Generic entry will lead to significant price reductions.

What is the Regulatory Status and Future Outlook for Pomalyst?

Pomalyst has received regulatory approvals from major health authorities globally, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Its approved indications have expanded over time based on clinical data.

• FDA Approvals: Initial approval in 2013 for relapsed/refractory multiple myeloma. Subsequent approvals for other indications and patient populations.
• EMA Approvals: Similar approval pathways and indications.
• Future Label Expansions: While ongoing clinical trials might explore new uses or combinations, the primary driver of future market share will be its positioning against generic alternatives and newer modalities.
• Post-Patent Landscape: The post-patent era for Pomalyst will be characterized by intense price competition from multiple generic manufacturers. BMS will likely focus on its lifecycle management strategies, including potential combination therapies or new formulations, although these face significant headwinds from generic alternatives.

What are the Key Factors Influencing Pomalyst's Future Market Trajectory?

The future market trajectory of Pomalyst is primarily shaped by the impending generic competition and the evolving landscape of multiple myeloma treatment.

• Generic Competition Timeline: The precise timing and extent of generic entry across different geographies is paramount. The U.S. market has seen initial generic launches in early 2024.
• Pricing Pressures: Generic versions will be priced significantly lower than branded Pomalyst, leading to rapid market share erosion for the originator product.
• Healthcare Payer Policies: Payer formulary decisions and reimbursement policies will influence which Pomalyst products (branded or generic) are preferred and accessible to patients.
• Clinical Integration of Newer Therapies: The increasing adoption of CAR T-cell therapies and other novel agents in earlier lines of treatment for multiple myeloma may reduce the pool of patients eligible for or receiving Pomalyst in later lines.
• BMS Strategic Response: BMS’s strategy for managing the decline of Pomalyst, potentially through portfolio management or focusing on newer assets, will impact its overall oncology franchise.

Key Takeaways

Pomalyst has been a significant revenue generator for Bristol Myers Squibb, driven by its efficacy in relapsed and refractory multiple myeloma. However, the drug's commercial lifecycle is nearing a critical inflection point due to the expiration of its primary patent protections and the subsequent entry of generic competitors. This shift is expected to lead to a substantial decline in Pomalyst's revenue. The competitive landscape in multiple myeloma treatment is dynamic, with emerging cell therapies and novel agents presenting ongoing challenges. The strategic response of Bristol Myers Squibb to this impending genericization will be crucial in mitigating revenue loss and maintaining its position in the oncology market.

Frequently Asked Questions

1. When did generic versions of Pomalyst become available in the U.S.? Generic versions of Pomalyst began entering the U.S. market in early 2024 following patent expirations and legal resolutions.

2. What is the expected impact of generic competition on Pomalyst sales? Industry analysts project a significant decline in Pomalyst sales, potentially exceeding 70% in the first year of widespread generic availability, due to price erosion and market share transfer to lower-cost generic alternatives.

3. How does Pomalyst compare to newer CAR T-cell therapies in treating multiple myeloma? Pomalyst is an oral immunomodulatory drug used in later lines of therapy. CAR T-cell therapies, such as Abecma and Carvykti, are more intensive, autologous treatments that offer deep and durable responses, often used in patients who have failed multiple prior lines of therapy, including drugs like Pomalyst. Their efficacy and safety profiles are distinct.

4. What is the primary indication for which Pomalyst is prescribed? Pomalyst is primarily prescribed for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor, and have demonstrated disease progression on or after the last therapy. It also has an indication for Kaposi sarcoma.

5. What is the therapeutic class of Pomalyst? Pomalyst belongs to the class of immunomodulatory drugs (IMiDs). It is a derivative of thalidomide and shares similar, though distinct, mechanisms of action, including immunomodulatory, anti-angiogenic, and direct anti-tumor effects.

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Citations

[1] American Cancer Society. (2023). Cancer Facts & Figures 2023. Retrieved from https://www.cancer.org/research/cancer-facts-statistics/all-cancer-facts-figures/cancer-facts-figures-2023.html

[2] Bristol Myers Squibb. (2024). Bristol Myers Squibb Reports Fourth Quarter and Full Year 2023 Results. Retrieved from https://newsroom.bms.com/news/bristol-myers-squibb-reports-fourth-quarter-and-full-year-2023-results/