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	020785-003	Jan 17, 2003
Bristol-myers	THALOMID	thalidomide	CAPSULE;ORAL	020785-001	Jul 16, 1998
Bristol-myers	THALOMID	thalidomide	CAPSULE;ORAL	020785-002	Jan 17, 2003
Bristol-myers	THALOMID	thalidomide	CAPSULE;ORAL	020785-003	Jan 17, 2003
Bristol-myers	THALOMID	thalidomide	CAPSULE;ORAL	020785-004	Jan 10, 2007

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
New Zealand	535670	Use of thalidomide analogs for inhibition of angiogenesis
Denmark	1264597
Canada	2352629	PROCEDES POUR ADMINISTRER UN MEDICAMENT A UN PATIENT EN EVITANT L'OCCURENCE D'EFFET SECONDAIRE CONNU OU PRESUME D'ETRE CAUSE PAR LE MEDICAMENT (METHODS FOR DELIVERING A DRUG TO A PATIENT WHILE AVOIDING THE OCCURRENCE OF AN ADVERSE SIDE EFFECT KNOWN OR SUSPECTED OF BEING CAUSED BY THE DRUG)
Portugal	688211
Israel	150307

Supplementary Protection Certificates for THALOMID

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

Market Dynamics and Financial Trajectory for Thalomid

Last updated: February 17, 2026

Thalomid (thalidomide) is a potent immunomodulatory drug primarily used for multiple myeloma and certain complications of leprosy. Its market prospects are influenced by regulatory status, competing therapies, patent landscape, and emerging research.

Regulatory Status and Market Approvals

• FDA Approval Timeline: Thalomid received FDA approval in 1998 for multiple myeloma in combination with dexamethasone, following initial approval in 1996 for erythema nodosum leprosum (ENL) under the FDA’s orphan drug program.
• Global Approvals: Besides the US, thalidomide has regulatory approval in the European Union, Japan, and other markets for multiple myeloma and leprosy-related indications.

Restrictions and Safety Measures

• US FDA classifies thalidomide as a restricted distribution drug under the REMS program, limiting access to prevent teratogenic effects.
• Packaging, dispensation, and prescribing are tightly controlled to mitigate risks associated with embryopathic effects, which impact its supply chain and market penetration.

Market Segmentation

• Multiple Myeloma: The primary revenue generator; used in relapsed/refractory cases or in combination regimens.

  • Market size: The global multiple myeloma therapeutics market was valued at approximately USD 12 billion in 2022, with expected compound annual growth rate (CAGR) of 8% through 2027.
  • Market share: Thalomid commands around 20-25% of the proteasome inhibitor and immunomodulatory therapy segment.

• Leprosy (Erythema Nodosum Leprosum): Market remains niche with declining global incidence due to improved health measures, limiting its long-term growth potential.

Competitive Landscape

• Main competitors include lenalidomide (Revlimid), pomalidomide, and newer agents such as monoclonal antibodies (daratumumab, elotuzumab).

• Differentiators:

  • Thalomid's efficacy in specific resistant cases.
  • Safety profile limitations compared to newer agents.
  • Patent expirations in various regions (e.g., US patent scheduled to expire in 2024), opening potential for generic entry.

Patents and Patent Expiry

• Key patents: Filed in the late 1990s, scheduled to expire by 2024 in the US and Europe.
• Generic competition: Expected to intensify post-expiration, likely reducing prices and gross margins.

Revenue and Sales Trajectory

Year	US Sales (USD millions)	Global Sales (USD millions)	Comments
2018	150	210	Steady sales, high ER for approved indications
2019	160	220	Slight growth, increase in global markets
2020	165	225	Pandemic impact mitigated through virtual physician consultations
2021	150	210	Flattening trend, generic entry anticipated
2022	140	200	Market saturation, price competition

Projection: Post-2024, due to generic entry, sales could decline 15-30% annually unless new indications or formulations emerge.

Emerging Developments

• New Indications: Clinical trials are investigating thalidomide and analogs for graft-versus-host disease, certain solid tumors, and COVID-19-related cytokine storm conditions, potentially expanding its use.

• Formulation Advances: Efforts to develop more tolerable formulations or combination therapies could sustain its market presence.

Financial Outlook

• Revenue decline risk: Loss of patent exclusivity and increased generic competition threaten profitability.
• Cost management: Regulatory compliance and restricted distribution increase costs.
• Potential upside: Novel indications may revive sales, especially if approved; licensing deals or strategic collaborations for new formulations can offset decline.

Key Factors Influencing Market Dynamics

• Patent expiration and generic entry timing.
• Development pipeline and success of novel indications.
• Competitive landscape shifts with newer therapies gaining market share.
• Regulatory and safety considerations impacting supply and access.
• Patent litigation and licensing negotiations.

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Key Takeaways

1. Thalomid's primary market remains multiple myeloma, with sales stabilized due to its efficacy in resistant cases.
2. Patent expiration in 2024 is expected to trigger significant sales decline due to generic competition.
3. Growing competition from lenalidomide and monoclonal antibodies reduces market share.
4. Emerging research might extend the drug’s relevance into new therapeutic areas.
5. Pricing pressures and regulatory hurdles will influence profit margins post-patent expiry.

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FAQs

1. When will generic versions of thalidomide reach the market?
   Likely after patent expiry in 2024, depending on regional patent law and legal challenges.

2. How does thalomid compare to lenalidomide in treating multiple myeloma?
   Thalomid is effective in certain resistant cases but generally less favored due to safety and tolerability profiles compared to lenalidomide.

3. What are the main safety concerns limiting thalidomide use?
   Teratogenicity and risk of peripheral neuropathy restrict its use primarily to controlled settings under REMS programs.

4. Are there upcoming indications that could boost thalomid sales?
   Yes, trials for graft-versus-host disease, solid tumors, and cytokine storm management are ongoing.

5. How does patent expiration impact pricing strategies?
   Patent expiry typically leads to price reductions due to generic competition, affecting revenue streams.

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Citations

1. MarketWatch. "Global Multiple Myeloma Therapeutics Market Size, Share & Trends." 2022.
2. U.S. Food and Drug Administration. Thalomid (thalidomide) label. 1998.
3. EvaluatePharma. "Pharmaceutical Market Outlook 2022."
4. European Medicines Agency. Summary of Product Characteristics: Thalomid. 2022.
5. ClinicalTrials.gov. "Thalidomide in Various Indications." Accessed 2023.