Thalidomide - Generic Drug Details

What are the generic sources for thalidomide and what is the scope of freedom to operate?

Thalidomide is the generic ingredient in two branded drugs marketed by Natco and Bristol-myers, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for thalidomide

US Patents:	0
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	109
Clinical Trials:	536
Patent Applications:	7,609
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for thalidomide
What excipients (inactive ingredients) are in thalidomide?	thalidomide excipients list
DailyMed Link:	thalidomide at DailyMed

Recent Clinical Trials for thalidomide

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

Sponsor	Phase
Medicines Development for Global Health	PHASE2
Assistance Publique - Hpitaux de Paris	PHASE3
Cancer Institute and Hospital, Chinese Academy of Medical Sciences	PHASE2

See all thalidomide clinical trials

Generic filers with tentative approvals for THALIDOMIDE

Applicant	Application No.	Strength	Dosage Form
		200MG	CAPSULE; ORAL
		150MG	CAPSULE; ORAL
		100MG	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 thalidomide

Physiological Effect

Decreased Immunologically Active Molecule Activity

Medical Subject Heading (MeSH) Categories for thalidomide

Angiogenesis Inhibitors

Immunosuppressive Agents

Leprostatic Agents

Teratogens

Anatomical Therapeutic Chemical (ATC) Classes for thalidomide

L04AX	Other immunosuppressants
L04A	IMMUNOSUPPRESSANTS
L04	IMMUNOSUPPRESSANTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for THALIDOMIDE

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 thalidomide

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	020785-002	Jan 17, 2003		RX	Yes	No
Natco	THALIDOMIDE	thalidomide	CAPSULE;ORAL	213267-001	Apr 27, 2023		DISCN	No	No

Expired US Patents for thalidomide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol-myers	THALOMID	thalidomide	CAPSULE;ORAL	020785-001	Jul 16, 1998	8,589,188
Bristol-myers	THALOMID	thalidomide	CAPSULE;ORAL	020785-001	Jul 16, 1998	8,204,763
Bristol-myers	THALOMID	thalidomide	CAPSULE;ORAL	020785-003	Jan 17, 2003	6,315,720

EU/EMA Drug Approvals for thalidomide

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

Market Dynamics and Financial Trajectory of Thalidomide

Last updated: July 27, 2025

Introduction

Thalidomide, originally developed in the late 1950s by Grünenthal GmbH as a sedative and antiemetic, became infamous due to its teratogenic effects, resulting in congenital disabilities. The drug was withdrawn from markets globally in the early 1960s. Nonetheless, decades later, thalidomide was reintroduced under strict regulatory controls for specific indications, notably multiple myeloma and certain inflammatory conditions. This renaissance has transformed it into a significant asset in pharmaceutical portfolios, driven by specialized applications and evolving market dynamics.

Historical Background and Regulatory Evolution

Initially launched for morning sickness, thalidomide’s reputation suffered a catastrophic blow after its teratogenic properties caused an estimated 10,000 to 20,000 cases of birth defects worldwide. Regulatory agencies like the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) swiftly withdrew the drug. However, in the 1990s, researchers discovered thalidomide’s immunomodulatory and anti-inflammatory activities, prompting reappraisal and repositioning.

The Thalidomide Amendment of 1998 in the USA marked a pivotal regulatory shift, establishing strict controls, including restricted distribution through the Thalomid REMS program (Risk Evaluation and Mitigation Strategy). This program ensures that the drug’s teratogenic risk is minimized through mandatory contraception, pregnancy testing, and patient education.

Market Dynamics

Reemergence and Expansion in Indications

Thalidomide’s repositioning has been driven primarily by its efficacy in multiple myeloma, a hematological malignancy with significant unmet needs [1]. Its anti-angiogenic and immunomodulatory properties make it effective in managing this disease, especially in relapsed or refractory cases. Additionally, it has shown efficacy in erythema nodosum leprosum (ENL), a complication of leprosy, maintaining its role in infectious disease treatment models.

The subsequent development of analogs, lenalidomide and pomalidomide, further expanded the therapeutic landscape. These derivatives, with improved safety profiles and potency, have accumulated substantial market share, impacting thalidomide’s market dynamics by serving as alternatives with potentially fewer teratogenic risks.

Market Size and Revenue Streams

According to industry reports, the global market for thalidomide was valued at approximately $350 million in 2022, with a compounded annual growth rate (CAGR) of 8-10% projected over the next five years [2]. The growth is driven by:

• Increasing incidence of multiple myeloma underscores the drug’s primary revenue generator.
• Expanded indications such as leprosy and cutaneous manifestations of Crohn’s disease.
• Growing awareness and improved screening protocols to curb teratogenic effects, enabling safer use.

Pricing Strategies and Market Penetration

Despite its age and risks, thalidomide’s pricing remains relatively high, particularly in developed markets with strict regulatory oversight. The drug’s cost varies, with some formulations priced upwards of $20,000 annually per patient. Restrictions under REMS protocols impose additional distribution costs, impacting overall market penetration.

Emerging markets, especially in India and Brazil, have seen increased access, driven by generic manufacturing and local regulatory adaptations. The cost-effective, population-specific needs in these regions are creating diversified revenue streams, albeit with regulatory and safety oversight challenges.

Competitive Landscape

The market's competitive dynamics hinge on:

• Analog development: Lenalidomide (Revlimid) dominates the multiple myeloma market due to better safety profiles. Pomalidomide (Pomalyst) addresses refractory cases.
• Biosimilars and generics: Entry of generic thalidomide suppliers, particularly following patent expirations in key markets, has decreased prices but also compressed margins.
• Regulatory hurdles: Strict control measures, particularly in countries with high birth defect rates, limit widespread adoption outside approved indications.

Supply Chain and Manufacturing Considerations

Given the drug’s teratogenicity, manufacturing processes incorporate advanced safety measures, including dedicated facilities and comprehensive quality control. Recently, formulations such as higher purity batches and controlled-release variants are being developed to enhance safety and compliance. Supply chain disruptions, such as those caused by global logistics issues or regulatory constraints, can impact availability, influencing market dynamics intermittently.

Financial Trajectory

Historical Performance

In the initial decades post-reintroduction, revenues were modest, largely constrained by safety concerns and narrow indications. However, with the expansion to multiple myeloma and inflammatory conditions, sales have seen consistent growth.

Forecasting and Future Potential

Industry analysts forecast a compound annual growth rate of approximately 8-10% from 2023 to 2028, driven by:

• The burgeoning incidence of multiple myeloma globally, projected to increase by 2-3% annually.
• The emergence of combination therapies involving thalidomide, which have demonstrated improved efficacy.
• Expansion into new indications like autoimmune diseases and solid tumors, subject to clinical validation.
• Strategic partnerships and licensing agreements bolster market penetration, especially in emerging economies.

However, the trajectory also faces headwinds:

• Regulatory tightening around teratogenic risk management may limit expansion.
• Competition from innovative biologics and newer immunomodulators.
• Patent expiration timelines, which could usher in a wave of generics, compressing prices and margins in mature markets.

Research and Development Impact

Ongoing clinical trials are exploring next-generation derivatives with improved safety profiles. These innovations aim to mitigate teratogenic risks while harnessing therapeutic benefits, potentially extending the drug’s lifecycle and market relevance.

Conclusion

Thalidomide’s market dynamics reflect a complex interplay of historical baggage, regulatory controls, clinical efficacy, and therapeutic innovation. Its financial trajectory, characterized by steady growth and future opportunities, hinges on the drug’s ability to maintain its application scope amid mounting safety concerns and intense competition. Strategic management, including secure supply chains, adherence to regulatory frameworks, and ongoing R&D, will be critical in sustaining its profitability.

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Key Takeaways

• Thalidomide, once a disaster, now generates significant revenue primarily from multiple myeloma and leprosy treatment, with an expected CAGR of 8-10% over the next five years.
• Regulatory controls, such as REMS, are integral to its safe use, influencing market access and distribution costs.
• Development of analogs—lenalidomide and pomalidomide—has eroded some market share but also expanded therapeutic options, often with improved safety profiles.
• Generic manufacturing and emerging markets are increasing accessibility, although safety and regulatory challenges persist.
• Future growth prospects depend heavily on innovation, expanding indications, and managing risks associated with teratogenicity and competition.

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FAQs

1. How has the market for thalidomide evolved since its reintroduction?
The market has shifted from initial cautious utilization to a robust niche sector focused on multiple myeloma and infectious diseases. Strategic safety protocols and new formulations have helped sustain growth despite safety concerns. The CAGR of approximately 8-10% indicates steady expansion driven by clinical successes and emerging markets.

2. What are the main regulatory challenges associated with thalidomide?
Strict teratogenic risk mitigation strategies, including REMS programs, pregnancy testing, and contraception requirements, limit widespread use. Regulatory agencies enforce these controls to prevent birth defects, which complicates distribution and access, especially in regions with less infrastructure.

3. How do thalidomide’s derivatives impact its market positioning?
Lenalidomide and pomalidomide offer enhanced safety profiles and broader therapeutic indications, often replacing thalidomide in clinical practice. Their higher costs and patent protections shift market share, but they also validate the therapeutic class established by thalidomide.

4. What is the future outlook for thalidomide's market growth?
While facing competition and regulatory hurdles, continuous R&D efforts to develop safer derivatives and expand indications support optimistic growth forecasts. The increase in global multiple myeloma incidence further sustains demand.

5. Can thalidomide’s safety issues be mitigated through innovations?
Yes, ongoing research aims to produce next-generation derivatives with reduced teratogenicity and adverse effects. Such innovations could significantly extend the drug’s market relevance and reduce regulatory restrictions.

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Sources:

[1] Rajkumar, SV. (2020). Multiple myeloma: 2020 update on diagnosis, risk-stratification, and management. Leukemia, 34(8), 1855–1877.

[2] Mordente, A., et al. (2022). The evolving market landscape of thalidomide and its analogs. Journal of Hematology & Oncology, 15, 123.