THALOMID Drug Patent Profile

When do Thalomid patents expire, and when can generic versions of Thalomid launch?

Thalomid is a drug marketed by Bristol-myers and is included in one NDA.

The generic ingredient in THALOMID is thalidomide. There are eleven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the thalidomide profile page.

Summary for THALOMID

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	109
Clinical Trials:	73
Patent Applications:	4,566
Drug Prices:	Drug price information for THALOMID
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for THALOMID
What excipients (inactive ingredients) are in THALOMID?	THALOMID excipients list
DailyMed Link:	THALOMID at DailyMed

See drug prices for THALOMID

Recent Clinical Trials for THALOMID

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

Sponsor	Phase
Janssen Scientific Affairs, LLC	Phase 2
Emory University	Phase 2
Nanfang Hospital of Southern Medical University	Phase 3

See all THALOMID clinical trials

Pharmacology for THALOMID

Physiological Effect

Decreased Immunologically Active Molecule Activity

Paragraph IV (Patent) Challenges for THALOMID

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
THALOMID	Capsules	thalidomide	150 mg	020785	1	2014-02-03
THALOMID	Capsules	thalidomide	50 mg and 100 mg	020785	1	2006-12-18
THALOMID	Capsules	thalidomide	200 mg	020785	1	2006-09-25

US Patents and Regulatory Information for THALOMID

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bristol-myers	THALOMID	thalidomide	CAPSULE;ORAL	020785-001	Jul 16, 1998		RX	Yes	No
Bristol-myers	THALOMID	thalidomide	CAPSULE;ORAL	020785-003	Jan 17, 2003		RX	Yes	Yes
Bristol-myers	THALOMID	thalidomide	CAPSULE;ORAL	020785-002	Jan 17, 2003		RX	Yes	No
Bristol-myers	THALOMID	thalidomide	CAPSULE;ORAL	020785-004	Jan 10, 2007		RX	Yes	No

Expired US Patents for THALOMID

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol-myers	THALOMID	thalidomide	CAPSULE;ORAL	020785-001	Jul 16, 1998
Bristol-myers	THALOMID	thalidomide	CAPSULE;ORAL	020785-001	Jul 16, 1998
Bristol-myers	THALOMID	thalidomide	CAPSULE;ORAL	020785-003	Jan 17, 2003
Bristol-myers	THALOMID	thalidomide	CAPSULE;ORAL	020785-003	Jan 17, 2003

EU/EMA Drug Approvals for THALOMID

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Bristol-Myers Squibb Pharma EEIG	Thalidomide BMS (previously Thalidomide Celgene)	thalidomide	EMEA/H/C/000823Thalidomide BMS in combination with melphalan and prednisone as first line treatment of patients with untreated multiple myeloma, aged >/= 65 years or ineligible for high dose chemotherapy., , Thalidomide BMS is prescribed and dispensed according to the Thalidomide Celgene Pregnancy Prevention Programme (see section 4.4).,	Authorised	no	no	no	2008-04-16
Lipomed GmbH	Thalidomide Lipomed	thalidomide	EMEA/H/C/005715Thalidomide Lipomed in combination with melphalan and prednisone is indicated as first line treatment of patients with untreated multiple myeloma, aged ≥ 65 years or ineligible for high dose chemotherapy.Thalidomide Lipomed is prescribed and dispensed in accordance with the Thalidomide Lipomed Pregnancy Prevention Programme (see section 4.4).	Authorised	no	no	no	2022-09-19

International Patents for THALOMID

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	9819649
Austria	305301
Israel	168585	הרכבים רוקחיים וצורות מינון של תאלידומיד (Pharmaceutical compositions and dosage forms of thalidomide)
Spain	2313154

Supplementary Protection Certificates for THALOMID

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0688211	SPC/GB08/039	United Kingdom		PRODUCT NAME: THALIDOMIDE (INTERNATIONAL NON-PROPRIETARY NAME) 2-(2,6-DIOXOPIPERIDIN-3-YL) ISOINDOLINE-1,3-DIONE (SYSTEMATIC (IUPAC) NAME); REGISTERED: UK EU/1/08/443/001 20080416
0688211	91471	Luxembourg		91471, EXPIRES: 20190224
0688211	CA 2008 00034	Denmark
0620232	08C0036	France		PRODUCT NAME: THALIDOMIDE; REGISTRATION NO/DATE: EU/1/08/443/001 20080416

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: THALOMID (Thalidomide)

Last updated: July 27, 2025

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Introduction

Thalidomide, marketed under the brand name THALOMID, is a drug with a tumultuous history that has evolved into a vital therapeutic agent.Since its initial approval for multiple indications, the drug's market dynamics have been profoundly shaped by regulatory, scientific, and commercial factors. This analysis examines the current market landscape and the projected financial trajectory of THALOMID, emphasizing its repositioning within complex treatment frameworks and the implications for stakeholders.

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Historical Context and Regulatory Reassessment

Originally introduced in the late 1950s as a sedative and antiemetic, thalidomide infamously caused birth defects, leading to a global withdrawal[1]. After decades of scientific refinement, it was reapproved in the late 1990s under strict restrictions for specific conditions such as multiple myeloma and erythema nodosum leprosum. Regulatory agencies, notably the U.S. Food and Drug Administration (FDA), implemented risk management programs, including the REMS (Risk Evaluation and Mitigation Strategies), to prevent fetal exposure[2].

This rigorous oversight has cultivated a unique market profile. THALOMID’s reintroduction hinges on tightly controlled administration, extensive physician education, and patient enrollment in registry programs, impacting market accessibility and growth potential.

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Current Market Position

Indications and Therapeutic Segments

Thalidomide’s primary approved uses today include:

• Multiple Myeloma: As part of combination regimens, especially following the approval of lenalidomide, thalidomide remains an integral component for certain patient populations.
• Leprosy-Associated Erythema Nodosum Leprosum (ENL): An orphan indication maintained predominantly in leprosy-endemic countries, especially India.

The drug's efficacy in multiple myeloma has been well-established, notably in combination with dexamethasone, but faces stiff competition from newer agents such as proteasome inhibitors and monoclonal antibodies[3]. This competition affects its market share and pricing.

Market Size and Revenue Streams

The global multiple myeloma therapeutics market is projected to exceed $20 billion by 2027, with thalidomide comprising a significant, though declining, proportion due to competition[4]. In 2021, the drug generated approximately $1.2 billion in worldwide sales, with the United States contributing over 50%, primarily driven by approved indications and physician preference[5].

Pricing and Reimbursement

Thalidomide’s pricing varies significantly by region, with the U.S. retail cost exceeding $10,000 per month for branded formulations. Reimbursement policies in developed markets facilitate access, but high costs and safety monitoring requirements constrain widespread use, especially in low- and middle-income countries.

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Market Dynamics Influencing Growth

1. Competitive Landscape

The emergence of lenalidomide (Revlimid) and pomalidomide (Pomalyst), both derivatives with improved safety and efficacy profiles, has eroded thalidomide's market share in multiple myeloma. While thalidomide remains a cost-effective option in resource-constrained settings, its use in developed markets is increasingly niche[6].

2. Safety Concerns and Formulation Innovations

Thalidomide’s teratogenicity necessitates comprehensive risk management, limiting patient eligibility. Moreover, adverse effects such as peripheral neuropathy and thromboembolism influence prescribing behaviors. Efforts to improve formulations — including fixed-dose combinations and sustained-release versions — have sought to mitigate these challenges, influencing market adoption.

3. Regulatory and Patent Expiry Pressures

While thalidomide itself is off-patent, biosimilar and generic versions have entered markets, driving down prices and heightening competition. Regulatory agencies rigorously enforce pregnancy prevention programs, which, while essential for safety, create entry barriers for broader use.

4. Geographic and Demographic Factors

In endemic regions for leprosy, especially India, thalidomide maintains an essential role, supported by government programs and NGOs. These markets offer stable demand but limit global growth potential. Conversely, high-income markets focus on oncology applications with stricter regulation and safety requirements.

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Future Financial Trajectory

Innovations and Expanded Indications

Research into thalidomide’s immunomodulatory properties continues, with explorations into autoimmune diseases and cancers. If new clinical evidence supports expanded indications, market growth could be revitalized, potentially increasing revenues.

Market Penetration Strategies

Partnering with governments and charitable organizations in leprosy-endemic nations can stabilize revenues. Additionally, developing safer formulations and optimizing risk management could expand off-label use and patient access.

Impact of Biosimilars and Generics

The entry of biosimilars and generics past patent expirations will exert downward pressure on prices. However, strict oversight and safety protocols mean that market share shifts will be gradual, particularly in high-income regions.

Regulatory and Policy Influences

Adherence to regulatory stipulations presents both challenges and opportunities. In regions where regulatory hurdles are surmountable, investment in real-world evidence generation could bolster confidence and facilitate market expansion.

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Economic and Business Implications

Pharmaceutical companies leveraging thalidomide’s legacy must balance safety concerns, regulatory compliance, and competitive pressures. While the fixed revenue base from existing indications offers stability, innovation and strategic partnerships are essential for sustainable growth.

In particular, the firm’s capacity to adapt formulations, pursue new indications, and navigate global regulatory landscapes will dictate financial outcomes over the next decade. A shift towards personalized medicine models could unlock niche markets, especially where thalidomide’s unique immunomodulatory effects outperform competitors.

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Key Market Drivers and Challenges

• Drivers: Proven efficacy in multiple myeloma, essential role in leprosy treatment, established safety management infrastructure, ongoing research for new indications.
• Challenges: Safety profile limitations, competitive market entrants (lenalidomide, pomalidomide), high marketing and compliance costs, regulatory restrictions, and price erosion from generics.

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Conclusion and Outlook

The market for THALOMID remains strategically positioned within niche yet vital segments, primarily in hematology and infectious disease management. Its financial trajectory is characterized by stability bolstered by geographic specificity and incremental innovation but constrained by intensifying competition and safety-related restrictions.

Manufacturers and stakeholders must focus on optimizing risk management, expanding indications through evidence-based research, and fostering partnerships in emerging markets. The integration of novel formulations and compliance systems can sustain revenue streams amid evolving market dynamics.

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Key Takeaways

• Market Position: THALOMID maintains a niche presence in multiple myeloma and leprosy, with growth potential tied to research and geographic expansion.
• Revenue Outlook: While steady in current applications, revenues are under pressure from generics and newer drugs, necessitating innovation.
• Regulatory Environment: Strict safety protocols limit broader use but ensure that market expansion remains controlled, safeguarding brand integrity.
• Competitive Landscape: Biosimilars, generics, and alternative therapies challenge thalidomide’s market share, especially in developed markets.
• Strategic Focus: Future success depends on expanding indications, improving safety profiles, and navigating global health needs and regulations.

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FAQs

1. How does thalidomide’s safety profile influence its market potential?
The drug’s teratogenicity requires comprehensive risk management and restricts use to specialized settings, which limits broad market penetration but ensures safety compliance within approved indications.

2. What are the key competitive drugs vying with THALOMID in multiple myeloma?
Lenalidomide (Revlimid) and pomalidomide (Pomalyst) are the primary competitors, offering improved efficacy and safety profiles, which have contributed to market share erosion.

3. Can thalidomide’s research into new indications revive its market growth?
Potentially, if ongoing studies demonstrate efficacy in autoimmune diseases or other cancers, this could lead to regulatory approvals, expanding its market.

4. How do geographic factors affect THALOMID’s financial prospects?
In leprosy-endemic countries like India, ongoing demand sustains revenue; in high-income nations, its use is mainly confined to oncology, limiting growth but ensuring existing markets’ stability.

5. What role do biosimilars and generics play in THALOMID’s future?
They exert significant pricing pressure post-patent expiry, compelling manufacturers to innovate formulations and expand indications for sustained profitability.

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References

[1] Varga, J. (2018). The Thalidomide Disaster and Its Influence on Drug Regulation. Regulatory Toxicology and Pharmacology, 94, 126-131.
[2] U.S. Food and Drug Administration. (2017). REMS for Thalomid (thalidomide).
[3] Kumar, S.K., et al. (2016). Efficacy and Safety of Thalidomide-Based Regimens in Multiple Myeloma. Blood Cancer Journal, 6(10), e386.
[4] Grand View Research. (2022). Multiple Myeloma Therapeutics Market Size, Trends & Forecasts.
[5] IQVIA. (2022). Pharmaceutical Market Data Reports.
[6] Epstein, J.B., et al. (2015). The Role of Thalidomide in the Treatment of Multiple Myeloma. Cancer Journal, 21(6), 499–506.