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:	150
Clinical Trials:	73
Patent Applications:	4,470
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	020785-004	Jan 10, 2007
Bristol-myers	THALOMID	thalidomide	CAPSULE;ORAL	020785-004	Jan 10, 2007
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	020785-003	Jan 17, 2003
Bristol-myers	THALOMID	thalidomide	CAPSULE;ORAL	020785-002	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/000823 Thalidomide 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/005715 Thalidomide 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
Brazil	9400764
Germany	69738935
New Zealand	336035	Angiogenesis inhibitory composition comprising an inhibitory compound and antiinflammatory drug
Hong Kong	1052865
Australia	2005202596
Denmark	1586322
New Zealand	262676	METHOD OF INHIBITING ANGIOGENESIS IN A NON-HUMAN ANIMAL USING THALIDOMIDE AND ANALOGUES THEREOF

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
0688211	SPC025/2008	Ireland		SPC025/2008: 20090811, EXPIRES: 20190223
0688211	C300358	Netherlands		PRODUCT NAME: THALIDOMIDE; REGISTRATION NO/DATE: EU/1/08/443/001 20080416
0688211	300358	Netherlands		300358, 20140224, EXPIRES: 20190223

THALOMID Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Thalomid

Introduction to Thalomid

Thalomid, also known as thalidomide, is an immunomodulatory drug that has undergone a significant transformation from its controversial past to its current status as a treatment for various serious diseases. Here, we will delve into the market dynamics and financial trajectory of Thalomid.

Historical Context and Repurposing

Thalidomide was initially introduced in the 1950s but was withdrawn from the market due to severe side effects. However, in the late 20th century, it was repurposed for treating serious and debilitating diseases. In 1999, its efficacy in treating multiple myeloma was reported, leading to its approval in 2006 for this indication[5].

Market Growth and Forecast

The Thalomid market has experienced substantial growth and is expected to continue this trend. Here are some key points:

Market Size and CAGR

The global thalidomide market is projected to grow at a CAGR of 6.80% from 2021 to 2028, driven by increasing prevalence of diseases such as multiple myeloma, erythema nodosum leprosum, and others[4].

Geographical Segmentation

North America currently dominates the thalidomide market due to the presence of major pharmaceutical companies, a well-developed healthcare sector, and high drug costs. However, the Asia-Pacific region is expected to show significant growth due to increasing R&D activities, emerging markets, and growing government support[4].

Application and Product Segmentation

Thalomid is segmented by application (multiple myeloma, erythema nodosum leprosum, graft vs. host disease, renal cell carcinoma, etc.) and product type (50mg, 100mg, 200mg). These segments are crucial for understanding the diverse uses and market potential of the drug[1][4].

Financial Performance

The financial trajectory of Thalomid, particularly through its association with Celgene (now part of Bristol-Myers Squibb), has been remarkable.

Revenue and Profitability

Celgene extracted billions of dollars in revenue from Thalomid's analog, Revlimid, which was developed subsequent to Thalomid's repurposing. From 2009 to 2018, Celgene reported over $51 billion in net worldwide revenue from Revlimid, with the U.S. market accounting for $32 billion of that total. This revenue significantly fueled Celgene's profitability, with net income growing nearly every year after the drug's launch[2].

Pricing Strategies

Pricing decisions for Thalomid and its analogs have been driven by revenue and earnings goals. For instance, Celgene implemented several price increases for Revlimid to meet quarterly revenue targets, reflecting a strategy that prioritizes financial performance over other considerations[2].

Market Dynamics

Drivers

• Increasing Prevalence of Diseases: The rise in diseases such as multiple myeloma and erythema nodosum leprosum is a significant driver for the thalidomide market[4].
• Government Funding and Supportive Strategies: Growing government funding and supportive healthcare policies are boosting the market[4].
• R&D Activities: Major pharmaceutical companies' focus on novel treatment therapies and R&D activities is providing beneficial opportunities for the market[4].

Restraints

• High Drug Costs: The high cost of thalidomide and its associated side effects are major restraints on market growth[4].
• Side Effects: Side effects such as fever, burning eyes, skin pain, rashes, hives, and breathing difficulties are significant challenges[4].

Opportunities

• Emerging Markets: The growing healthcare sector in emerging markets presents opportunities for expansion[4].
• Academic-Industry Collaborations: Successful repurposing of thalidomide highlights the importance of academic-industry collaborations, which can lead to new treatment options and market growth[5].

Challenges

• Patent Cliff: The expiration of patent protection for thalidomide and its analogs could have a material adverse effect on the business of pharmaceutical companies[2][3].
• Regulatory Scrutiny: The drug pricing and revenue strategies of pharmaceutical companies are under increasing regulatory scrutiny, which could impact future pricing decisions and revenue streams[2].

Competitive Landscape

The competitive landscape of the thalidomide market includes several key players, with Celgene (now part of Bristol-Myers Squibb) being a major player. The market analysis includes company overviews, financials, R&D investments, new market initiatives, and global presence of these companies[4].

Market Outlook and Analysis

Porter's 5 Forces Framework

The market outlook involves a comprehensive analysis using Porter's 5 Forces Framework, which includes the threat of new entrants, bargaining power of suppliers, bargaining power of buyers, threat of substitute products, and competitive rivalry among existing competitors[1].

Value Chain and Pricing Analysis

The report also includes a detailed analysis of the value chain and pricing strategies, which are critical in understanding the market dynamics and future growth prospects[1].

Key Takeaways

• Substantial Growth: The thalidomide market is expected to grow significantly, driven by increasing disease prevalence and R&D activities.
• Financial Performance: The drug has generated substantial revenue and profitability for its manufacturers.
• Market Dynamics: The market is influenced by various drivers, restraints, opportunities, and challenges, including government funding, high drug costs, and regulatory scrutiny.
• Competitive Landscape: The market is competitive, with major pharmaceutical companies playing a significant role.

FAQs

What is Thalomid used for?

Thalomid is used for treating multiple myeloma, erythema nodosum leprosum, graft vs. host disease, and other serious diseases.

How has the market for Thalomid grown?

The market for Thalomid has grown substantially, with a projected CAGR of 6.80% from 2021 to 2028.

What are the main drivers of the Thalomid market?

The main drivers include increasing prevalence of diseases, government funding, and R&D activities by major pharmaceutical companies.

What are the significant restraints on the Thalomid market?

High drug costs and associated side effects are major restraints on market growth.

Who are the key players in the Thalomid market?

Celgene (now part of Bristol-Myers Squibb) is a major player, along with other pharmaceutical companies involved in R&D and market expansion.

Sources

1. Market Research Intellect: Thalomid Market Size and Forecast[1]
2. House Oversight Committee: Drug Pricing Investigation[2]
3. Pharmaceuticals.gov.in: An Analysis on Leveraging the Patent Cliff[3]
4. Data Bridge Market Research: Global Thalidomide Market[4]
5. Science.org: Drug Repurposing: Misconceptions, Challenges, and Opportunities[5]