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 four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Pomalidomide has three hundred and fifty-seven patent family members in forty-eight countries.

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

Summary for POMALIDOMIDE

International Patents:	357
US Patents:	4
Tradenames:	2
Applicants:	7
NDAs:	7
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	147
Clinical Trials:	253
Patent Applications:	5,713
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
Megalabs	Phase 1
University of Chicago	Phase 2
Regeneron Pharmaceuticals	Phase 3

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
Breckenridge	POMALIDOMIDE	pomalidomide	CAPSULE;ORAL	210111-002	Oct 30, 2020		DISCN	No	No
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026-004	Feb 8, 2013	AB	RX	Yes	Yes	8,828,427*PED				Y
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026-002	Feb 8, 2013	AB	RX	Yes	No
Hetero Labs Ltd V	POMALIDOMIDE	pomalidomide	CAPSULE;ORAL	210236-003	Sep 26, 2024	AB	RX	No	No
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026-004	Feb 8, 2013	AB	RX	Yes	Yes

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	8,158,653
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026-003	Feb 8, 2013	6,315,720
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026-004	Feb 8, 2013	6,316,471
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026-003	Feb 8, 2013	6,561,976
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026-001	Feb 8, 2013	6,561,977

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/002682 Imnovid 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
South Africa	200803700	Methods using 3-(4-amino-1oxo-1,3-dihydro-isoindol-2-yl)-piperdine-2,6-dione for treatment of certain leukemias
Brazil	PI0414084	composto, mistura, e, composição
Hong Kong	1134019	治療癌症的藥物組合物 (PHARMACEUTICAL COMPOSITIONS FOR TREATING CANCER)
Israel	198978	3-(4-AMINO -1-OXO-1,3- DIHYDRO- ISOINDOL-2- YL)- PIPERIDINE-2,6 DIONE OR 4-(AMINO)-2-(2,6 DIOXO(3-PIPERIDYL))-ISOINDOLINE-1,3-DIONE FOR TREATING AMYLOIDOSIS
South Korea	20120014114	FORMULATIONS OF 4-AMINO-2-(2,6-DIOXOPIPERIDINE-3-YL)ISOINDOLINE-1,3-DIONE

Supplementary Protection Certificates for POMALIDOMIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
2105135	CA 2015 00006	Denmark		PRODUCT NAME: POMALIDOMID OG FARMACEUTISK ACCEPTABLE SALTE, SOLVATER, HYDRATER ELLER STEREOISOMERER HERAF; REG. 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
2105135	300717	Netherlands		PRODUCT NAME: POMALIDOMIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN, SOLVATEN, HYDRATEN OF STEREOISOMEREN DAARVAN; REGISTRATION NO/DATE: EU/1/13/850 20130805

POMALIDOMIDE Market Analysis and Financial Projection Experimental

Pomalidomide Market Dynamics and Financial Trajectory

Introduction

Pomalidomide, a potent immunomodulatory drug, has emerged as a crucial treatment option for patients with multiple myeloma, particularly those who have relapsed or become refractory to other treatments. Here, we delve into the market dynamics and financial trajectory of pomalidomide, highlighting key drivers, challenges, and future outlook.

Market Growth Drivers

The pomalidomide market is driven by several significant factors:

Increasing Prevalence of Multiple Myeloma

The rising incidence of multiple myeloma globally has created a growing demand for effective treatment options. Pomalidomide, with its proven efficacy in treating relapsed and refractory multiple myeloma, has become a vital component in the treatment arsenal[1].

Clinical Outcomes and Efficacy

Pomalidomide has demonstrated positive clinical outcomes, including prolonged progression-free survival and overall survival rates. This efficacy has contributed to its adoption and growth in the market[1].

Expanding Clinical Trials and Research

Ongoing clinical trials evaluating pomalidomide in combination with other drugs and its potential use in treating other types of cancer, such as solid tumors, offer opportunities for market expansion beyond multiple myeloma[1].

Increasing Healthcare Expenditure

Rising healthcare expenditure in both developed and developing countries has enabled greater access to advanced cancer treatments, including pomalidomide. This increased spending is a significant driver of market growth[1].

Regional Market Dynamics

North America

North America, particularly the United States, holds the largest market share due to the high incidence rate of multiple myeloma and the presence of established pharmaceutical companies in the region. The robust healthcare infrastructure and high demand for advanced treatments contribute to the market's dominance in this region[1][4].

Asia-Pacific

The Asia-Pacific region is expected to witness the highest growth rate due to improving healthcare infrastructure, increasing awareness about multiple myeloma, and rising disposable income levels. Countries like China, Japan, and South Korea are noteworthy markets in this region[1][4].

Competitive Landscape

The pomalidomide market is highly competitive, with key players such as Celgene, Natco Pharma, Intas Pharmaceuticals, and others focusing on research and development activities to introduce novel drugs and expand their market share. Strategic collaborations and partnerships are also crucial in enhancing market penetration and research capabilities[1][4].

Economic Analysis and Cost-Effectiveness

Cost-Effectiveness Studies

Studies have shown that pomalidomide, when compared to best supportive care or high-dose dexamethasone, offers significant quality-adjusted life years (QALYs) gains. For instance, in Sweden, pomalidomide treatment was found to provide a QALY gain of 0.7351 with an incremental cost of approximately €62,400, highlighting its cost-effectiveness in improving patient outcomes[5].

Incremental Cost-Effectiveness Ratio (ICER)

The ICER for pomalidomide has been estimated to be around $84,900 per QALY gained, indicating that while the treatment is costly, it provides substantial clinical benefits. These economic analyses are crucial for healthcare providers and policymakers in making funding decisions[2][5].

Challenges and Restraints

High Treatment Costs

One of the significant challenges facing the pomalidomide market is the high cost of treatment, which can limit accessibility, particularly in developing regions. The cost of therapy with pomalidomide is a major contributor to the overall treatment expense[1][5].

Adverse Effects and Safety Concerns

While generally well-tolerated, pomalidomide can have adverse effects that impact patient compliance and acceptance. Managing these side effects is essential to ensure continued patient outcomes and market growth[1].

Stringent Regulatory Requirements

Stringent regulatory requirements and delays in approvals can hinder market entry and growth. Navigating these regulatory hurdles is critical for pharmaceutical companies to maintain market momentum[1].

Future Outlook

Continued Research and Development

Ongoing research and clinical trials evaluating new indications and combination therapies will be pivotal in expanding the market. The exploration of pomalidomide in treating other cancer types can open up new revenue streams for pharmaceutical companies[1].

Geographic Expansions

Expansion into emerging markets, such as Asia-Pacific and Latin America, presents significant growth opportunities. Improving healthcare infrastructure and increasing awareness about multiple myeloma in these regions will drive market growth[1].

Strategic Collaborations and Patient-Centric Approaches

Strategic collaborations with healthcare organizations and implementing patient assistance programs can help improve access to pomalidomide for patients facing financial constraints. A patient-centric approach will be crucial in shaping the future of the pomalidomide market[1].

Key Trends and Industry Developments

Integration with Other Therapies

The trend of combining pomalidomide with other drugs to enhance treatment efficacy is expected to continue. This approach can lead to better patient outcomes and further market growth[1].

Digital Transformation and Technological Advancements

Technological advancements and digital transformation in the healthcare sector are likely to influence the pomalidomide market. Innovations in product offerings and healthcare delivery systems will shape the market's expansion[4].

Impact on Stakeholders

Pharmaceutical Companies

The pomalidomide market presents lucrative opportunities for pharmaceutical companies to generate revenue through drug sales. Expansion in emerging markets, development of novel drug combinations, and strategic collaborations can enhance market share and profitability[1].

Healthcare Providers

Pomalidomide provides healthcare providers with an effective treatment option for multiple myeloma patients, especially those who have relapsed or become refractory to other treatments. The drug’s positive clinical outcomes can improve patient survival rates and quality of life[1].

Patients

For patients, pomalidomide offers a potential life-extending treatment option. The drug’s efficacy and safety profile can enhance patient outcomes and quality of life, providing hope to those with limited treatment alternatives[1].

Key Takeaways

• The pomalidomide market is driven by the increasing prevalence of multiple myeloma and the demand for effective treatment options.
• North America holds the largest market share, while the Asia-Pacific region is expected to witness the highest growth rate.
• The market is highly competitive, with key players focusing on research and development.
• High treatment costs and adverse effects are significant challenges.
• Ongoing research, strategic collaborations, and geographic expansions will shape the future of the pomalidomide market.

FAQs

What is the current size of the pomalidomide market?

The current size of the pomalidomide market is estimated to be in the billions of dollars, with precise figures varying by source and region[4].

What are the key factors driving the growth of the pomalidomide market?

Key factors include the increasing prevalence of multiple myeloma, positive clinical outcomes, expanding clinical trials, and rising healthcare expenditure[1].

Which regions are expected to see the highest growth in the pomalidomide market?

The Asia-Pacific region is expected to witness the highest growth rate due to improving healthcare infrastructure and increasing awareness about multiple myeloma[1][4].

What are the major challenges facing the pomalidomide market?

Major challenges include high treatment costs, adverse effects, and stringent regulatory requirements[1].

How does pomalidomide impact patient outcomes?

Pomalidomide significantly improves patient outcomes by providing prolonged progression-free survival and overall survival rates, enhancing quality of life for multiple myeloma patients[1][5].

Cited Sources

1. MarkWide Research: "Pomalidomide market 2024-2032 | Size, Share, Growth"[1]
2. Pan-Canadian Oncology Drug Review: "pCODR Final Economic Guidance Report - Pomalidomide (Pomalyst) for Multiple Myeloma"[2]
3. WICZ: "Pomalidomide Market Size, Trends | Growth, 2024-2032"[3]
4. HubSpot: "Pomalidomide Market By Type | Future Projections 2032"[4]
5. PubMed: "Cost effectiveness of pomalidomide in patients with relapsed and refractory multiple myeloma"[5]