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Last Updated: December 21, 2024

THALOMID Drug Patent Profile


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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.

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Drug patent expirations by year for THALOMID
Drug Prices for THALOMID

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Recent Clinical Trials for THALOMID

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

SponsorPhase
Janssen Scientific Affairs, LLCPhase 2
Emory UniversityPhase 2
Nanfang Hospital of Southern Medical UniversityPhase 3

See all THALOMID clinical trials

Pharmacology for THALOMID
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 ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bristol-myers THALOMID thalidomide CAPSULE;ORAL 020785-003 Jan 17, 2003 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bristol-myers THALOMID thalidomide CAPSULE;ORAL 020785-002 Jan 17, 2003 RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bristol-myers THALOMID thalidomide CAPSULE;ORAL 020785-004 Jan 10, 2007 RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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 8,589,188 ⤷  Subscribe
Bristol-myers THALOMID thalidomide CAPSULE;ORAL 020785-004 Jan 10, 2007 6,561,976 ⤷  Subscribe
Bristol-myers THALOMID thalidomide CAPSULE;ORAL 020785-002 Jan 17, 2003 6,315,720 ⤷  Subscribe
Bristol-myers THALOMID thalidomide CAPSULE;ORAL 020785-004 Jan 10, 2007 6,315,720 ⤷  Subscribe
Bristol-myers THALOMID thalidomide CAPSULE;ORAL 020785-004 Jan 10, 2007 6,561,977 ⤷  Subscribe
Bristol-myers THALOMID thalidomide CAPSULE;ORAL 020785-004 Jan 10, 2007 7,141,018 ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for THALOMID

See the table below for patents covering THALOMID around the world.

Country Patent Number Title Estimated Expiration
Canada 2514681 METHODES ET COMPOSITIONS VISANT A L'INHIBITION DE L'ANGIOGENESE (METHODS AND COMPOSITIONS FOR INHIBITION OF ANGIOGENESIS) ⤷  Subscribe
Spain 2313154 ⤷  Subscribe
Austria 493983 ⤷  Subscribe
Japan 4065373 ⤷  Subscribe
China 101816626 Pharmaceutical compositions and dosage forms of thalidomide ⤷  Subscribe
New Zealand 535670 Use of thalidomide analogs for inhibition of angiogenesis ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for THALOMID

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0688211 08C0036 France ⤷  Subscribe PRODUCT NAME: THALIDOMIDE; REGISTRATION NO/DATE: EU/1/08/443/001 20080416
0688211 CA 2008 00034 Denmark ⤷  Subscribe
0688211 300358 Netherlands ⤷  Subscribe 300358, 20140224, EXPIRES: 20190223
0688211 SPC/GB08/039 United Kingdom ⤷  Subscribe 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 ⤷  Subscribe 91471, EXPIRES: 20190224
0688211 SPC025/2008 Ireland ⤷  Subscribe SPC025/2008: 20090811, EXPIRES: 20190223
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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]

More… ↓

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