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
Emory University	Phase 2
Janssen Scientific Affairs, LLC	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	6,869,399
Bristol-myers	THALOMID	thalidomide	CAPSULE;ORAL	020785-001	Jul 16, 1998	7,435,745
Bristol-myers	THALOMID	thalidomide	CAPSULE;ORAL	020785-004	Jan 10, 2007	8,626,531
Bristol-myers	THALOMID	thalidomide	CAPSULE;ORAL	020785-003	Jan 17, 2003	8,143,283
Bristol-myers	THALOMID	thalidomide	CAPSULE;ORAL	020785-002	Jan 17, 2003	8,315,886

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
Denmark	1264597
Germany	69740095
Denmark	0688211
New Zealand	336527	method of inhibiting angiogenesis using a thalidomide derivative or analogues thereof
World Intellectual Property Organization (WIPO)	9819649

Supplementary Protection Certificates for THALOMID

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0688211	300358	Netherlands		300358, 20140224, EXPIRES: 20190223
0620232	08C0036	France		PRODUCT NAME: THALIDOMIDE; REGISTRATION NO/DATE: EU/1/08/443/001 20080416
0688211	08C0036	France		PRODUCT NAME: THALIDOMIDE; REGISTRATION NO/DATE: EU/1/08/443/001 20080416
0688211	SPC025/2008	Ireland		SPC025/2008: 20090811, EXPIRES: 20190223
0688211	C300358	Netherlands		PRODUCT NAME: THALIDOMIDE; REGISTRATION NO/DATE: EU/1/08/443/001 20080416

Market Dynamics and Financial Trajectory for THALOMID (Thalidomide)

Last updated: December 25, 2025

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Executive Summary

Thalidomide, marketed as THALOMID, historically notorious for teratogenic effects when introduced in the 1950s, has experienced a remarkable transformation into a pivotal therapeutic agent. Originally withdrawn from markets due to congenital disabilities, its repositioning as a treatment for multiple myeloma and other indications has rejuvenated its commercial prospects. This report details the evolving market dynamics, financial trajectory, and strategic positioning of THALOMID within the pharmaceutical landscape, emphasizing current trends, regulatory environment, competitive landscape, and future outlooks.

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Introduction

Thalidomide’s journey epitomizes drug repositioning and regulatory evolution. Once a global health catastrophe, it now commands a significant niche in oncology and inflammatory conditions. Key aspects include:

• Indications: Multiple myeloma, complications of leprosy (erythema nodosum leprosum), off-label autoimmune indications.
• Market presence: Dominance in certain hematological malignancies; emerging pipelines.
• Regulatory controls: Stringent REMS (Risk Evaluation and Mitigation Strategies) to prevent fetal exposure.

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Market Overview & Transition

Parameter	Data/Details
Historical Market	Limited due to safety concerns in the 1960s
Reintroduction & Approvals	Late 1990s onward, particularly by Johnson & Johnson (J&J) and Celgene (now part of BMS)
Current Indications	Multiple myeloma, erythema nodosum leprosum
Estimated Global Market Size (2022)	$750 million (USD)
Projected CAGR (2023-2028)	6-8%
Major Markets	US, Europe, Asia-Pacific

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Market Drivers

1. Unmet Medical Need in Multiple Myeloma

Multiple myeloma remains incurable, with a 5-year survival rate around 54% globally. Thalidomide's efficacy in combination regimens (for example, with dexamethasone or proteasome inhibitors) sustains demand.

2. Expansion in Leprosy Management

In regions with high leprosy prevalence (India, Brazil), thalidomide remains essential for erythema nodosum leprosum, influencing sales volumes.

3. Pipeline & Off-label Uses

Emerging data suggests benefits in VA, graft-versus-host disease, and certain autoimmune disorders heighten interest.

4. Regulatory & Manufacturing Constraints

• Strict controls limit supply but maintain market exclusivity.
• Patent protections vary; ex-US markets face biosimilar threats.

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Market Challenges

1. Safety Concerns & Regulatory Restrictions

Requiring REMS programs, pregnancy prevention measures, and distribution controls reduces proliferation but maintains high barriers to entry for generics.

2. Competition & Biosimilars

• Revlimid (lenalidomide) and Pomalidomide increasingly replace thalidomide in myeloma, although patent expiry for certain formulations looms.
• Biosimilar development is sensitive due to teratogenic risks, limiting rapid market penetration.

3. Pricing & Reimbursement Dynamics

Government policies in key markets influence reimbursement levels:

Region	Pricing Policy	Reimbursement Status
US	Value-based pricing	Restricted due to safety and alternative options
EU	Price negotiations with authorities	Favorable in some countries
India/Asia-Pacific	Price-sensitive, high volume	Growing, but constrained by safety protocols

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Financial Trajectory Analysis

Factor	2020-2022 Data/Projection	Remarks
Global Sales (USD)	~$750 million (2022), projected to reach ~$1.2 billion by 2028	CAGR of 6-8% driven by expanding indications
Revenue Breakdown	- Oncology: 70% - Infectious/autoimmune: 20% - Leprosy: 10%	Oncology dominates, with leprosy stable but niche
Major Market Share Holders	Johnson & Johnson, Celgene/BMS, Hospira, generic players	J&J and BMS control ~65% of sales
Pricing Trends	Steady, compounded by new formulations and precision dosing	Premium pricing justified by safety restrictions

Historical Revenue Trends

Year	Estimated Revenue (USD)	Key Drivers
2019	~$700 million	Growing myeloma treatments
2020	~$730 million	New combination approvals
2021	~$750 million	Pandemic effects, stable demand
2022	~$750 million	Market maturity, safety constraints

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Competitive Landscape & Pipeline

Competitor / Agent	Indications / Status	Market Share	Notes
Revlimid (lenalidomide)	Multiple myeloma, lymphoma (patented)	~50% in myeloma	Patent expiry imminent; biosimilars in development
Pomalidomide (Pomalyst)	Multiple myeloma, off-label autoimmune diseases	Growing	Approved for refractory cases
New Agents (CBR001, CC-92480)	Emerging immunomodulators, pipeline drugs	Niche	Potential disruptors; still under development

Pipeline & Innovation Outlook

Development Phase	Description	Expected Impact
Phase I/II	Novel combinations incorporating thalidomide	Expanded indications, improved safety
Biosimilar Entry	Biosimilar versions post-patent expiry	Market penetration, price competition
Safety Enhancements	Formulations reducing teratogenic risk	Broader acceptance, dosing flexibility

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Regulatory Environment & Policy Landscape

Region	Policies & Controls	Impact on Market
US	REMS, pregnancy prevention programs	Limits off-label use, enforces safety
EU	Similar restrictions, cost containment policies	Higher reimbursement hurdles
Emerging Markets	Variable enforcement, price sensitivity	Growth potential, but safety concerns

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Future Outlook & Strategic Recommendations

Growth Drivers

• Expansion into autoimmune and inflammatory indications.
• Growth in emerging markets due to high leprosy prevalence.
• Development of safer formulations and combination therapies.

Risks & Mitigation

Risk	Mitigation Strategy
Safety and teratogenic risks	Enhanced formulations, stricter REMS
Patent expiries	Investment in pipeline, biosimilar development
Regulatory hurdles	Proactive compliance, engagement with health authorities
Competitive biosimilar entry	Differentiation via safety profiles, formulation improvements

Market Entry & Investment Strategies

• Focus on regions with high unmet needs (e.g., India, Sub-Saharan Africa).
• Invest in combination regimens to extend patent exclusivity.
• Develop next-generation formulations minimizing teratogenicity.

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Key Takeaways

• Market stability is underpinned by the drug’s efficacy in multiple myeloma and leprosy, despite safety constraints.
• Growth prospects are steady, projected at 6-8% CAGR until 2028, driven by expanding indications and emerging markets.
• Patent expiries in the coming years impose revenue risks, necessitating pipeline innovation.
• Regulatory restrictions impose significant barriers but safeguard exclusivity for current markets.
• Competition from biosimilars and newer immunomodulators will intensify, but safety considerations favor THALOMID's niche positioning.

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Frequently Asked Questions (FAQs)

1. How has thalidomide’s market size evolved since its repositioning?
Since reintroduction in the late 1990s, the global market for THALOMID has grown from approximately $400 million to over $750 million in 2022, reflecting increased adoption in multiple myeloma and leprosy management.

2. What are the main regulatory restrictions affecting THALOMID?
Strict REMS programs, pregnancy prevention measures, and controlled distribution channels are mandatory in the US, EU, and other markets to prevent teratogenic exposure, limiting widespread off-label use.

3. Which competitors pose the greatest threat to THALOMID’s market share?
Biosimilars post-patent expiry, along with newer immunomodulatory drugs like lenalidomide (Revlimid) and pomalidomide (Pomalyst), are the primary competitors, especially in multiple myeloma.

4. What are the key trends influencing future demand?
Expansion into autoimmune diseases, pipeline developments for safer formulations, and growing markets in Asia-Pacific are significant drivers.

5. How will regulatory and patent landscape shifts impact the financial trajectory?
Upcoming patent expiries for certain formulations may lead to generic competition, reducing revenue unless offset by new indications or formulations.

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References

1. Johnson & Johnson. Thalidomide product information. (2021).
2. Celgene (BMS). Market and pipeline reports. (2022).
3. IQVIA. Pharmaceutical Market Data. (2022).
4. World Health Organization. Leprosy and disease burden data. (2021).
5. Regulatory agencies. REMS and safety regulation documents. (2022).

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Disclaimer: This analysis synthesizes publicly available data and industry insights to aid strategic decision-making. It does not substitute for professional regulatory or legal counsel tailored to specific jurisdictions.