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:	539
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
Rongrong Liu	PHASE2
Zhengzhou University	PHASE4
Assistance Publique - Hpitaux de Paris	PHASE3

See all thalidomide clinical trials

Generic filers with tentative approvals for THALIDOMIDE

Applicant	Application No.	Strength	Dosage Form
		150MG	CAPSULE;ORAL
		200MG	CAPSULE; ORAL
		150MG	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
Natco	THALIDOMIDE	thalidomide	CAPSULE;ORAL	213267-001	Apr 27, 2023		DISCN	No	No
Bristol-myers	THALOMID	thalidomide	CAPSULE;ORAL	020785-004	Jan 10, 2007		RX	Yes	No
Bristol-myers	THALOMID	thalidomide	CAPSULE;ORAL	020785-003	Jan 17, 2003		RX	Yes	Yes

Expired US Patents for thalidomide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol-myers	THALOMID	thalidomide	CAPSULE;ORAL	020785-003	Jan 17, 2003	6,045,501
Bristol-myers	THALOMID	thalidomide	CAPSULE;ORAL	020785-001	Jul 16, 1998	8,143,283
Bristol-myers	THALOMID	thalidomide	CAPSULE;ORAL	020785-002	Jan 17, 2003	6,235,756

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

Thalidomide Market Analysis and Financial Projection

Last updated: February 12, 2026

What Are the Market Dynamics for Thalidomide?

Thalidomide, originally developed in the 1950s as a sedative and antiemetic, was withdrawn due to teratogenic effects. Its current market is centered on its approved medical applications, primarily multiple myeloma and certain complications of leprosy.

Current Market Size and Growth

• The global thalidomide market was valued at approximately USD 250 million in 2022.
• Projected Compound Annual Growth Rate (CAGR): 5.3% from 2023 to 2028; driven by expanding indications and new formulations.
• Major markets include the US, Europe, and Japan, which account for roughly 75% of sales.

Application and Indication Dynamics

• Multiple Myeloma: The largest revenue driver. Thalidomide (marketed as Thalomid) combined with dexamethasone remains a frontline treatment.
• Leprosy: Approved under the WHO's Model List of Essential Medicines for lepra reactions, but sales have declined due to alternative therapies.
• Other Potential Uses: Investigations into Crohn’s disease, certain cancers, and COVID-19 complications are ongoing but not yet reflected in sales.

Competitive Landscape

• Thalidomide faces competition from drugs like lenalidomide and pomalidomide, which are derivatives with improved safety profiles.
• Biosimilars and generics are limited due to patent exclusivity and manufacturing complexity.
• Key players include Celgene (now part of Bristol-Myers Squibb), which maintains a dominant position.

Regulatory and Policy Influences

• Stricter prescribing controls and risk management programs (such as REMS in the US) restrict access to mitigate teratogenic risks.
• Patent expirations for some formulations have occurred, opening opportunities for generics.

Supply Chain Considerations

• Manufacturing is complex, involving controlled distribution to prevent misuse.
• Supply disruptions are rare but could impact sales and access.

What Is the Financial Trajectory for Thalidomide?

Revenue Trends

Year	Estimated Revenue (USD millions)	Notes
2021	240	Growth driven by new indications and global adoption
2022	250	Stabilization; slight increase from 2021
2023	263	Projected, assuming a 5.3% CAGR, with market expansion

Key Revenue Drivers

• Adoption in combination therapies for multiple myeloma continues increasing.
• New formulations, such as controlled-release tablets, may command higher prices.
• Geographic expansion in emerging markets presents growth opportunities.

Cost and Price Trends

• Wholesale prices have shown slight reductions due to generic entry in some regions.
• Manufacturing expenses remain high, mainly due to stringent safety and distribution protocols.

Investment and R&D Outlook

• R&D investments focus on derivatives with improved safety, such as lenalidomide.
• Limited pipeline: no major new formulations for thalidomide are publicly announced, but ongoing clinical trials could influence future sales.

Risks and Challenges

• Safety concerns pose regulatory and reputational risks.
• Patent expirations threaten market share; competitors or biosimilars may enter markets within the next 1-3 years.
• Market saturation in key indications may limit revenue growth.

What Are the Key Drivers and Constraints?

Market Drivers

• Established efficacy in multiple myeloma
• Favorable reimbursement policies in developed countries
• Expanding access in emerging markets

Market Constraints

• Teratogenic risk restricts widespread use
• Competition from safer derivatives
• Regulatory hurdles limit off-label use

Summarized Outlook

Thalidomide's market remains niche but stable, with moderate growth driven by ongoing treatment needs in multiple myeloma. Regulatory controls, safety considerations, and patent landscapes shape the competitive environment. The financial trajectory indicates steady revenue with limited potential for exponential growth absent new indications or formulations.

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Key Takeaways

• Thalidomide’s 2022 global market valuation is ~$250 million, with a CAGR of 5.3% forecasted through 2028.
• Main revenue sources include multiple myeloma treatment and leprosy management.
• Competition from derivatives like lenalidomide affects future market share.
• Regulated prescribing and safety measures constrain broader adoption.
• Revenues are stabilized but face risks from patent expiration and competition.

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FAQs

1. How does thalidomide’s safety profile impact its market? It limits use to controlled settings, increasing regulatory scrutiny and restricting off-label applications.

2. Are biosimilars affecting thalidomide’s profitability? Biosimilars are less relevant due to chemical nature; however, generics could impact pricing once patents expire.

3. What are potential future indications for thalidomide? Research continues into autoimmune diseases, certain cancers, and infectious diseases, but regulatory approval is uncertain.

4. How do regulatory policies influence market access? Policies like REMS programs limit distribution, adding compliance costs but reducing misuse risk.

5. What is the outlook for thalidomide in emerging markets? Growing healthcare infrastructure and unmet needs could expand access, supporting revenue growth.

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References

1. Market data sourced from Allied Market Research, 2022.
2. Regulatory status and safety policies from FDA and EMA guidelines.
3. Competitive landscape and patent information from industry reports, 2023.