Pomalyst Drug Patent Profile

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

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

This drug has three hundred and fifty-nine patent family members in forty-eight countries.

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

DrugPatentWatch^® Generic Entry Outlook for Pomalyst

Pomalyst was eligible for patent challenges on February 8, 2017.

There have been thirty-one patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (pomalidomide), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for Pomalyst

International Patents:	359
US Patents:	4
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 four 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	204026-004	Feb 8, 2013		RX	Yes	Yes					Y
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026-004	Feb 8, 2013		RX	Yes	Yes
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026-001	Feb 8, 2013		RX	Yes	No					Y
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026-003	Feb 8, 2013		RX	Yes	No					Y
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026-001	Feb 8, 2013		RX	Yes	No
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026-001	Feb 8, 2013		RX	Yes	No					Y
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026-002	Feb 8, 2013		RX	Yes	No					Y

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	204026-001	Feb 8, 2013
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026-003	Feb 8, 2013
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026-001	Feb 8, 2013
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026-002	Feb 8, 2013
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026-002	Feb 8, 2013
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026-003	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
Luxembourg	91359
European Patent Office	2087891	Compositions pharmaceutiques pour le traitement du lymphome (Pharmaceutical compositions for treating lymphoma)
Israel	174067	צורות פולימורפיות של 3-(4-אמינו-1-אוקסו-1, 3 דיהידרו-איסואינדול-2-יל)-פיפרידין-6,2-דיון (Polymorphic forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione)
Denmark	1486496
Japan	2005530784
Canada	2752124	METHODES ET COMPOSITIONS A BASE DE 3-(4-AMINO-1-OXO-1,3-DIHYDROISOINDOL-2-YL)-PIPERIDINE-2,6-DIONE POUR LE TRAITEMENT ET LA GESTION DU CANCER DE LA TETE ET DU COU (METHODS AND COMPOSITIONS USING 3-(4-AMINO-1-OXO-1,3-DIHYDROISOINDOL-2-YL)-PIPERIDINE-2,6-DIONE FOR TREATMENT AND MANAGEMENT OF HEAD AND NECK CANCER)
Norway	332271

Supplementary Protection Certificates for Pomalyst

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0925294	SZ 56/2007	Austria		PRODUCT NAME: 1-OXO-2(2,6-DIOXOPIPERIDIN-3-YL)-4- AMINOISOINDOLIN, AUCH 3-(4'AMINOISOINDOLIN-1'-ON)- 1-PIPERIDIN-2,6DION GENANNT, GEGEBENENFALLS IN FORM EINES SAEUREADDITIONSSALZES
2105135	300717	Netherlands		PRODUCT NAME: POMALIDOMIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN, SOLVATEN, HYDRATEN OF STEREOISOMEREN DAARVAN; REGISTRATION NO/DATE: EU/1/13/850 20130805
0925294	C00925294/01	Switzerland		PRODUCT NAME: LENALIDOMIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 57712 29.08.2007
0925294	SPC/GB07/047	United Kingdom		PRODUCT NAME: LENALIDOMIDE (COMMON NAME) 1-OXO-2-(2,6-DIOXOPIPERIDIN-3-YL)-4-AMINOSOINDOLINE OPTIONALLY IN THE FORM OF AN ACID ADDITION SALT; REGISTERED: UK EU/1/07/391/001 20070619; UK EU/1/07/391/002 20070619; UK EU/1/07/391/003 20070619; UK EU/1/07/391/004 20070619
0925294	CA 2007 00054	Denmark		PRODUCT NAME: LENALIDOMID, EVT. I FORM AF SYREADDITIONSSALT

Market Dynamics and Financial Trajectory for POMALYST (Pomalidomide)

Last updated: November 19, 2025

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Introduction

Pomalidomide, marketed under the brand name POMALYST, is a credited therapeutic agent primarily used for multiple myeloma (MM), particularly in relapsed and refractory cases. Since its approval by the U.S. Food and Drug Administration (FDA) in 2013, POMALYST has established itself as a vital component within hematologic oncology, driven by unique pharmacological properties and strategic market positioning. This analysis explores the evolving market dynamics, competitive landscape, regulatory influences, and financial outlook shaping POMALYST’s trajectory.

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Pharmacological Profile and Clinical Positioning

Pomalidomide belongs to the immunomodulatory drug (IMiD) class, akin to thalidomide and lenalidomide, but with enhanced potency against multiple myeloma cells. It exerts anti-inflammatory, immunostimulatory, and anti-angiogenic effects, making it effective in patients refractory to prior therapies, including lenalidomide and bortezomib[^1].

Its clinical use is largely confined to relapsed/refractory multiple myeloma (RRMM), often following failure of previous lines of treatment. The drug’s efficacy, combined with manageable side-effect profiles, sustains demand within oncology markets, especially among heavily pretreated patients.

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Market Landscape and Drivers

1. Growing Incidence of Multiple Myeloma

Globally, the incidence of multiple myeloma is rising due to aging populations and improved diagnostics. The American Cancer Society estimates approximately 34,000 new cases annually in the U.S. alone, with similar trends nationally and globally[^2]. This increasing patient pool drives demand for therapeutics like POMALYST.

2. Treatment Paradigm Shifts

The therapeutic landscape for MM has evolved significantly with the advent of novel agents, including proteasome inhibitors, monoclonal antibodies, and IMiDs. POMALYST occupies a critical niche in salvage therapy, particularly in heavily pretreated populations[^3].

Furthermore, combination regimens involving POMALYST (e.g., with dexamethasone, daratumumab) demonstrate enhanced efficacy and are expanding its use, bolstering market growth.

3. Evolving Resistance Patterns and Unmet Needs

Resistance to existing therapies prompts clinicians to seek alternative options like POMALYST. Its efficacy in patients refractory to lenalidomide and bortezomib underpins its value, sustaining its clinical and commercial relevance.

4. Competitive Dynamics

While POMALYST enjoys market exclusivity until 2027 in the U.S. owing to patent protection, its position faces competition from emerging agents, biosimilars, and next-generation therapies. Notably, agents like selinexor and CAR-T cell therapies are beginning to redefine RRMM treatment algorithms[^4].

5. Regulatory and Reimbursement Environment

Reimbursement policies and potential price negotiations influence market access, particularly in key regions like the U.S., Europe, and Asia. The pricing of POMALYST, justified by its clinical benefits, remains a key driver of revenue.

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Financial Trajectory and Revenue Streams

1. Historical and Projected Sales Data

Since its launch, POMALYST has experienced robust revenue growth attributable to its first-mover advantage and clinical efficacy. For example, in 2020, the drug generated approximately $1 billion globally, with continued growth projected as adoption expands[^5].

The COVID-19 pandemic temporarily disrupted supply chains and patient access, but recovery has been swift due to the ongoing necessity of MM therapies.

2. Market Penetration and Geographic Expansion

Initially dominated by the U.S., POMALYST’s sales are increasingly driven by European and Asian markets, aided by regulatory approvals and localized reimbursement strategies[^6].

The rollout of combination treatments and inclusion in clinical guidelines enhances its adoption, supporting sustained revenue streams.

3. Patent Protection and Generic Competition

Patent exclusivity extends until 2027 in the U.S., underpinning revenue stability. Post-expiry, biosimilars and generics may emerge, exerting downward pressure on pricing and revenues.

Strategic lifecycle management, including new formulation development and expanding indications, aims to prolong market dominance.

4. Investment in Clinical Development

Biogen and Celgene (now part of Bristol-Myers Squibb following acquisition of Celgene in 2019) continue to invest in trials exploring POMALYST in combination with novel agents and indications like solid tumors, which could unlock additional revenue sources[^7].

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Regulatory and Market Challenges

1. Safety and Side-effect Profile

Adverse effects such as neuropathy, myelosuppression, and thromboembolic events necessitate vigilant management, impacting prescribing patterns and reimbursement negotiations.

2. Competition and Drug Discontinuation Risks

Emergence of superior therapies may limit POMALYST’s market share, necessitating innovation and combination regimen optimization.

3. Pricing and Access Pressures

Healthcare institutions and payers seek cost containment, potentially threatening profitability through formulary restrictions or price negotiations.

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Future Outlook and Strategies

1. Expansion into New Indications

Investigations into POMALYST's efficacy in other hematologic malignancies and solid tumors could diversify revenue streams.

2. Combination Regimens and Personalized Therapies

Developing tailored combination therapies could enhance response rates and extend market relevance. Notable ongoing trials involve POMALYST with monoclonal antibodies and novel agents.

3. Geographic and Demographic Expansion

Growing acceptance in emerging markets, supported by regulatory approvals, will likely accelerate revenue growth. Tailoring pricing strategies to regional economic contexts remains critical.

4. Lifecycle Initiatives

Patent protections provide a window for lifecycle extension via new formulations, dosing schedules, and approved uses, preserving market share amid competitive pressures.

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Key Takeaways

• POMALYST remains a cornerstone for relapsed/refractory multiple myeloma, with a growing global market driven by disease prevalence and evolving treatment paradigms.
• Its financial trajectory aligns with expanding indications, combination regimens, and geographic penetration, supported by patent exclusivity until 2027.
• Competitive threats from emerging therapies and biosimilars underscore the importance of ongoing clinical innovation and strategic lifecycle management.
• Regulatory, safety, and reimbursement factors significantly influence market access and profitability, necessitating proactive stakeholder engagement.
• Future growth will depend on successful expansion into new indications, combination strategies, and adaptation to regional healthcare dynamics.

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FAQs

1. What distinguishes POMALYST from other immunomodulatory drugs?
POMALYST exhibits greater potency and efficacy in patients refractory to lenalidomide, with a unique mechanism of action that enhances immune modulation and anti-angiogenesis. Its ability to overcome specific resistance patterns differentiates it within the IMiD class.

2. When is POMALYST expected to face generic competition?
Patent protection in the U.S. expires in 2027, after which biosimilars and generic versions are anticipated, potentially impacting pricing and market share.

3. Are there ongoing efforts to expand POMALYST’s approved uses?
Yes. Clinical trials are evaluating its efficacy in other hematologic cancers, such as mantle cell lymphoma and certain solid tumors, aiming to broaden therapeutic indications.

4. How does POMALYST’s safety profile impact its marketability?
While generally well-tolerated, risks like blood clots, neuropathy, and hematological toxicities require management strategies. These may influence clinician preferences and reimbursement negotiations.

5. What is the outlook for POMALYST’s sales in emerging markets?
As approvals expand and healthcare infrastructure improves, sales in Asia, Latin America, and Africa are expected to grow, contingent upon localized pricing strategies and reimbursement policies.

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References

[^1]: Rajkumar SV. Multiple myeloma: 2020 update on diagnosis, risk-stratification and management. Am J Hematol. 2020;95(5):548-567.
[^2]: American Cancer Society. Key Statistics for Multiple Myeloma. 2022.
[^3]: Kumar SK, et al. Multiple myeloma. Lancet. 2021;397(10272):430-447.
[^4]: Lonial S, et al. Treatment strategies for relapsed/refractory multiple myeloma. Nat Rev Clin Oncol. 2022;19(5):321-339.
[^5]: IQVIA. Pharmaceuticals Data and Market Trends Report, 2021.
[^6]: European Medicines Agency. Pomalidomide review and approval summary, 2013.
[^7]: Bristol-Myers Squibb. Annual Report 2022; Clinical Trials Database.