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Last Updated: December 22, 2024

THALIDOMIDE Drug Patent Profile


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When do Thalidomide patents expire, and what generic alternatives are available?

Thalidomide is a drug marketed by Natco and is included in one NDA.

The generic ingredient in THALIDOMIDE 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 THALIDOMIDE
Recent Clinical Trials for THALIDOMIDE

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

SponsorPhase
Mayo ClinicPhase 1
Shenyang Tenth People's HospitalPhase 2
Beijing Tsinghua Changgeng HospitalPhase 2

See all THALIDOMIDE clinical trials

Medical Subject Heading (MeSH) Categories for THALIDOMIDE
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 ⤷  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

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/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

THALIDOMIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Thalidomide

Introduction to Thalidomide

Thalidomide, a drug with a tumultuous history, has evolved from its initial use as a sedative to becoming a crucial treatment for several severe medical conditions, including multiple myeloma and leprosy. Here, we delve into the market dynamics and financial trajectory of thalidomide, highlighting its current status, growth drivers, challenges, and future outlook.

Market Size and Forecast

The thalidomide market is experiencing significant growth. As of 2023, the market size was valued at USD 10.6 billion and is projected to reach USD 15.5 billion by 2030, growing at a Compound Annual Growth Rate (CAGR) of 5% from 2024 to 2030[1].

Growth Drivers

Increased Disease Prevalence

The rising prevalence of diseases such as multiple myeloma, leprosy, and autoimmune illnesses is a key driver of the thalidomide market. As the global population ages, the incidence of these conditions is expected to increase, thereby boosting the demand for thalidomide and related formulations[1].

Research and Development

Ongoing research into new therapeutic uses of thalidomide, including its potential in treating various cancers and autoimmune diseases, is expanding its market potential. Clinical trials investigating novel indications could significantly increase demand[1].

Regulatory Approvals

Thalidomide's approval by health authorities for multiple diseases has increased its accessibility. Continued regulatory support and approvals are expected to further stimulate market growth[1].

Increasing Knowledge and Education

Greater awareness among patients and medical professionals about the therapeutic benefits of thalidomide is leading to an increase in prescriptions, contributing to market expansion[1].

Aging Population

The aging population is more susceptible to conditions like cancer and chronic inflammatory diseases, which thalidomide treats, thus fueling market growth[1].

Technological Advancements in Formulation

New approaches to drug formulation and delivery are enhancing the safety and effectiveness of thalidomide, attracting more medical professionals to prescribe the drug[1].

Market Expansion in Emerging Economies

The growing accessibility and affordability of thalidomide in emerging economies are creating new growth opportunities[1].

Challenges

Historical Controversy and Adverse Effects

Thalidomide's contentious past and associated adverse effects, such as nerve damage and birth defects, can make some medical professionals hesitant to recommend it, potentially restricting its use[1].

Patient Compliance Issues

The complexity of treatment plans and the need for continuous monitoring can impact patient compliance, hindering market growth[1].

Economic Factors

Economic limitations, particularly in developing countries, can affect the pricing and accessibility of thalidomide, restricting its use[1].

Intellectual Property Issues

The expiration of patents and the rise of generic competition can reduce the profitability of branded thalidomide products, affecting market dynamics[1].

Market Segmentation

By Product Type

The market is segmented by product type, including different dosages such as 50mg, 100mg, 150mg, and 200mg. Each dosage has specific applications and patient groups[4].

By Indication

Thalidomide is used for various indications, including multiple myeloma, erythema nodosum leprosum, graft vs. host disease, and renal cell carcinoma. The market growth is driven by the increasing prevalence of these diseases[4].

By Distribution Channel

The distribution channels include hospitals, retail pharmacies, and online pharmacies. Hospitals play a crucial role in administering thalidomide under controlled conditions, while retail and online pharmacies facilitate ongoing treatment[1].

By Geography

The market is segmented geographically into regions such as North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa. Each region has unique dynamics influenced by healthcare policies, economic factors, and disease prevalence[1].

Financial Performance and Pricing

Revenue and Profits

Thalidomide, particularly through its branded version Revlimid, has generated significant revenue. 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[3].

Pricing Strategies

Pricing decisions for thalidomide and its derivatives are often driven by revenue and earnings goals. For instance, Celgene's pricing strategies for Revlimid were focused on meeting company revenue targets and shareholder earnings goals, leading to significant price increases over the years[3].

Compensation and Support for Affected Individuals

Historically, thalidomide's use led to severe birth defects and other health issues. Compensation funds, such as the German Federal Contergan Foundation, have been established to support affected individuals. In Canada, a $168-million fund was set up to support ongoing medical and other needs of thalidomide victims[2][5].

Future Outlook

The global thalidomide market is expected to continue growing, driven by increasing disease prevalence, ongoing research, and expanding healthcare access. The Asia-Pacific region is particularly promising due to rising healthcare investment and growing research activities[1][4].

Key Takeaways

  • The thalidomide market is projected to grow significantly, driven by increasing disease prevalence and ongoing research.
  • Regulatory approvals and technological advancements in drug formulation are key growth drivers.
  • Challenges include historical controversy, patient compliance issues, economic factors, and intellectual property concerns.
  • The market is segmented by product type, indication, distribution channel, and geography.
  • Financial performance is strong, with significant revenue generated from branded versions like Revlimid.
  • Compensation and support for affected individuals remain crucial due to the drug's historical impact.

Frequently Asked Questions (FAQs)

Q: What are the primary uses of thalidomide today? A: Thalidomide is primarily used to treat multiple myeloma, erythema nodosum leprosum, and other conditions such as graft vs. host disease and renal cell carcinoma[1][4].

Q: How has the thalidomide market grown in recent years? A: The thalidomide market was valued at USD 10.6 billion in 2023 and is projected to reach USD 15.5 billion by 2030, growing at a CAGR of 5% from 2024 to 2030[1].

Q: What are the main challenges facing the thalidomide market? A: The main challenges include historical controversy and adverse effects, patient compliance issues, economic factors, and intellectual property concerns[1].

Q: How has thalidomide's past impacted its current use and regulation? A: The historical controversy surrounding thalidomide has led to stricter regulatory processes and increased caution in its prescription. However, it has also made the drug approval process safer and more rigorous[2].

Q: What regions are expected to drive the growth of the thalidomide market in the future? A: The Asia-Pacific region is expected to drive significant growth due to rising healthcare investment, increasing research activities, and growing government support[1][4].

Cited Sources

  1. Verified Market Research - Thalidomide Market Size, Scope, Trends, Growth And Forecast
  2. CBC News - The debt we owe Canada's thalidomide sufferers
  3. House Committee on Oversight and Reform - Drug Pricing Investigation
  4. Data Bridge Market Research - Global Thalidomide Market - Industry Trends and Forecast to 2028
  5. Thalidomide Tragedy - The history of the Thalidomide tragedy

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