THALIDOMIDE - Generic Drug Details

What are the generic sources for thalidomide and what is the scope of freedom to operate?

Thalidomide is the generic ingredient in two branded drugs marketed by Natco and Bristol-myers, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There are eleven drug master file entries for thalidomide. One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for THALIDOMIDE

US Patents:	0
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	150
Clinical Trials:	512
Patent Applications:	7,150
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for THALIDOMIDE
What excipients (inactive ingredients) are in THALIDOMIDE?	THALIDOMIDE excipients list
DailyMed Link:	THALIDOMIDE at DailyMed

Recent Clinical Trials for THALIDOMIDE

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

Sponsor	Phase
Mayo Clinic	Phase 1
Shenyang Tenth People's Hospital	Phase 2
Beijing Tsinghua Changgeng Hospital	Phase 2

See all THALIDOMIDE clinical trials

Generic filers with tentative approvals for THALIDOMIDE

Applicant	Application No.	Strength	Dosage Form
		200MG	CAPSULE; ORAL
		150MG	CAPSULE; ORAL
		100MG	CAPSULE; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for THALIDOMIDE

Physiological Effect

Decreased Immunologically Active Molecule Activity

Medical Subject Heading (MeSH) Categories for THALIDOMIDE

Angiogenesis Inhibitors

Immunosuppressive Agents

Leprostatic Agents

Teratogens

Anatomical Therapeutic Chemical (ATC) Classes for THALIDOMIDE

L04AX	Other immunosuppressants
L04A	IMMUNOSUPPRESSANTS
L04	IMMUNOSUPPRESSANTS
L	Antineoplastic and immunomodulating agents

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
Bristol-myers	THALOMID	thalidomide	CAPSULE;ORAL	020785-004	Jan 10, 2007		RX	Yes	No
Natco	THALIDOMIDE	thalidomide	CAPSULE;ORAL	213267-001	Apr 27, 2023		DISCN	No	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	020785-001	Jul 16, 1998		RX	Yes	No

Expired US Patents for THALIDOMIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol-myers	THALOMID	thalidomide	CAPSULE;ORAL	020785-003	Jan 17, 2003	6,561,977
Bristol-myers	THALOMID	thalidomide	CAPSULE;ORAL	020785-004	Jan 10, 2007	8,143,283
Bristol-myers	THALOMID	thalidomide	CAPSULE;ORAL	020785-004	Jan 10, 2007	8,589,188
Bristol-myers	THALOMID	thalidomide	CAPSULE;ORAL	020785-002	Jan 17, 2003	7,874,984
Bristol-myers	THALOMID	thalidomide	CAPSULE;ORAL	020785-003	Jan 17, 2003	6,755,784
Bristol-myers	THALOMID	thalidomide	CAPSULE;ORAL	020785-003	Jan 17, 2003	6,045,501
Bristol-myers	THALOMID	thalidomide	CAPSULE;ORAL	020785-002	Jan 17, 2003	6,755,784

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

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