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 four patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in POMALYST is pomalidomide. There are eleven drug master file entries for this compound. One supplier is 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 APOTEX on June 11^th, 2024.

Summary for POMALYST

International Patents:	357
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	147
Clinical Trials:	83
Patent Applications:	2,693
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 five 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	AB	RX	Yes	Yes					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	204026-003	Feb 8, 2013	AB	RX	Yes	No
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026-001	Feb 8, 2013	AB	RX	Yes	No					Y
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026-002	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	204026-003	Feb 8, 2013
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026-001	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/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 POMALYST

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3045175	FORMES POLYMORPHES DE 3-(4-AMINO-1-OXO-1,3 DIHYDRO-ISOINDOL-2-YL)-PIPÉRIDINE-2,6-DIONE (POLYMORPHIC FORMS OF 3-(4-AMINO-1-OXO-1,3 DIHYDROISOINDOL-2-YL)-PIPERIDINE-2,6-DIONE)
Norway	341039
South Africa	200409387	Methods and compositions using selective cytokine inhibitory drugs for treatment and management of cancers and other diseases
China	102675281	Polymorphic forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione
Norway	337446
Czech Republic	302378	Optický izomer (S)-1,3-dioxo-2-(2,6-dioxopiperidin-3-yl)-4-aminoisoindolin a farmaceutická kompozice s jeho obsahem ((S)-1,3-dioxo-2-(2,6-dioxopiperidin-3-yl)-4-aminoisoindoline optic isomer and pharmaceutical composition containing thereof)

Supplementary Protection Certificates for POMALYST

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	212 50002-2015	Slovakia		PRODUCT NAME: POMALIDOMID; REGISTRATION NO/DATE: EU/1/13/850/001 - EU/1/13/850/004 20130808
2105135	122015000013	Germany		PRODUCT NAME: POMALIDOMID UND SEINE PHARMAZEUTISCH AKZEPTABLEN SALZE, SOLVATE, HYDRATE ODER STEREOISOMERE (IMNOVID); REGISTRATION NO/DATE: EU/1/13/850 20130805
0925294	CA 2007 00054	Denmark		PRODUCT NAME: LENALIDOMID, EVT. I FORM AF SYREADDITIONSSALT
0925294	07C0056	France		PRODUCT NAME: LENALIDOMIDE; REGISTRATION NO/DATE: EU/1/07/391/001-004 20070618
2105135	C20150005 00140	Estonia		PRODUCT NAME: POMALIDOMIID;REG NO/DATE: EU/1/13/850 08.08.2013

POMALYST Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Pomalyst

Introduction

Pomalyst, the brand name for pomalidomide, is an immunomodulatory drug primarily used in the treatment of multiple myeloma, a type of blood cancer. The market for Pomalyst is characterized by several key dynamics and financial trends that are shaping its growth and future outlook.

Market Drivers

Increasing Prevalence of Multiple Myeloma

The rising incidence of multiple myeloma globally is a significant driver for the Pomalyst market. According to the American Cancer Society, there were approximately 32,110 new cases of multiple myeloma diagnosed in the U.S. in 2019, contributing to the demand for effective treatment options like Pomalyst[4].

Clinical Trials and Research

Ongoing clinical trials evaluating Pomalyst in combination with other drugs and for various cancer types, including solid tumors, are expanding its potential market. These trials offer opportunities for pharmaceutical companies to explore new indications and revenue streams[1].

Patient Assistance Programs

Patient assistance programs and collaborations with healthcare organizations are crucial in improving access to Pomalyst, especially for patients facing financial constraints. Bristol Myers Squibb's Patient Assistance Foundation, for example, provides free medicine to qualified patients, which helps in maintaining market penetration[3].

Regional Analysis

North America

North America holds the largest market share for Pomalyst, driven by the high incidence rate of multiple myeloma and the presence of well-established pharmaceutical companies. The favorable reimbursement framework in this region also supports market growth[1][4].

Europe

Europe is a significant market for Pomalyst, with countries like Germany, France, and the UK contributing to its growth. The region benefits from ongoing research and development activities and a favorable reimbursement framework[1].

Asia-Pacific

The Asia-Pacific region is expected to witness the highest growth rate due to improving healthcare infrastructure, rising disposable incomes, and increasing awareness about multiple myeloma. This region presents significant opportunities for market expansion[1][4].

Financial Performance

Revenue Trends

Pomalyst, marketed by Bristol Myers Squibb, has shown steady revenue growth. In the fourth quarter of 2022, Pomalyst/Imnovid revenues were $877 million, representing a 3% increase from the previous year[2].

Impact of Patient Assistance Programs

While patient assistance programs help in increasing access, they also impact revenue. For instance, the increase in utilization of free drug for Pomalyst, along with Revlimid, affected Bristol Myers Squibb's revenue in Q2 2023. However, this is offset by the overall growth in in-line products and the new product portfolio[3][5].

Challenges and Threats

High Cost of Treatment

The high cost of Pomalyst can limit its accessibility, particularly in developing regions. This is a significant challenge that pharmaceutical companies need to address through pricing strategies and patient support programs[1].

Adverse Effects

Although generally well-tolerated, Pomalyst can have adverse effects that may impact patient compliance and acceptance. Managing these side effects is crucial for maintaining patient trust and market growth[1].

Regulatory Requirements

Stringent regulatory requirements and delays in approvals can hinder market entry and growth. Pharmaceutical companies must navigate these regulatory challenges to ensure continuous market presence[1].

Opportunities

Expansion in Emerging Markets

Emerging markets such as Asia-Pacific and Latin America offer significant growth opportunities due to an increasing patient pool, improving healthcare infrastructure, and rising disposable incomes[1].

New Indications and Combination Therapies

Ongoing clinical trials exploring new indications and combination therapies can expand the market for Pomalyst. Collaborations and partnerships can also enhance market penetration and research capabilities[1].

Future Outlook

The Pomalyst market is expected to continue its growth trajectory driven by the increasing prevalence of multiple myeloma, ongoing research, and expanding market presence in emerging regions. However, challenges such as high treatment costs and safety concerns need to be addressed. Continued research, strategic collaborations, and a patient-centric approach will be crucial in shaping the future of the Pomalyst market[1].

Key Takeaways

• Growing Demand: The market for Pomalyst is driven by the increasing prevalence of multiple myeloma and the demand for effective treatment options.
• Regional Growth: North America holds the largest market share, while Asia-Pacific is expected to witness the highest growth rate.
• Financial Performance: Pomalyst has shown steady revenue growth, though impacted by patient assistance programs.
• Challenges: High treatment costs and adverse effects are significant challenges.
• Opportunities: Expansion in emerging markets and new indications offer growth opportunities.

FAQs

What is the primary use of Pomalyst?

Pomalyst is primarily used in the treatment of multiple myeloma, a type of blood cancer.

Which region holds the largest market share for Pomalyst?

North America holds the largest market share for Pomalyst due to the high incidence rate of multiple myeloma and the presence of established pharmaceutical companies.

What are the key drivers for the Pomalyst market?

The key drivers include the increasing prevalence of multiple myeloma, ongoing clinical trials, and patient assistance programs.

What challenges does the Pomalyst market face?

The market faces challenges such as high treatment costs, adverse effects, and stringent regulatory requirements.

What is the future outlook for the Pomalyst market?

The market is expected to continue growing driven by increasing prevalence, ongoing research, and expansion in emerging markets, but must address challenges like high costs and safety concerns.

Sources

1. MarkWide Research: Pomalidomide market 2024-2032 | Size, Share, Growth
2. Bristol Myers Squibb: Bristol Myers Squibb Reports Fourth Quarter and Full-Year Financial Results for 2022
3. Bristol Myers Squibb: Q2 2023 Results
4. BioSpace: Pomalidomide Market: Increasing rate of adoption of pomalidomide to drive the market
5. Bristol Myers Squibb: Bristol Myers Squibb Reports Second Quarter Financial Results for 2023