Methimazole - Generic Drug Details

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

Methimazole is the generic ingredient in two branded drugs marketed by Bionpharma, Chartwell Rx, Discovery Therap, Heritage Pharma, Macleods Pharms Ltd, Mylan, Qingdao Baheal Pharm, Rising, Sun Pharm Inds Inc, King Pharms, and King Pharms Llc, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.

There are three drug master file entries for methimazole. Fifteen suppliers are listed for this compound.

Summary for methimazole

US Patents:	0
Tradenames:	2
Applicants:	11
NDAs:	11
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	15
Raw Ingredient (Bulk) Api Vendors:	174
Clinical Trials:	22
Patent Applications:	5,310
Drug Prices:	Drug price trends for methimazole
Drug Sales Revenues:	Drug sales revenues for methimazole
What excipients (inactive ingredients) are in methimazole?	methimazole excipients list
DailyMed Link:	methimazole at DailyMed

See drug prices for methimazole

See drug sales revenues for methimazole

Recent Clinical Trials for methimazole

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

Sponsor	Phase
Case Comprehensive Cancer Center	Phase 2
The First Affiliated Hospital of Xiamen University	Phase 2/Phase 3
The Second Affiliated Hospital of Air Force Military Medical University	Early Phase 1

See all methimazole clinical trials

Pharmacology for methimazole

Drug Class	Thyroid Hormone Synthesis Inhibitor
Mechanism of Action	Thyroid Hormone Synthesis Inhibitors

Medical Subject Heading (MeSH) Categories for methimazole

Antithyroid Agents

US Patents and Regulatory Information for methimazole

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Qingdao Baheal Pharm	METHIMAZOLE	methimazole	TABLET;ORAL	040547-004	Feb 18, 2005		DISCN	No	No
Qingdao Baheal Pharm	METHIMAZOLE	methimazole	TABLET;ORAL	040547-002	Feb 18, 2005	AB	RX	No	No
Chartwell Rx	METHIMAZOLE	methimazole	TABLET;ORAL	040411-002	Mar 27, 2001	AB	RX	No	No
King Pharms	TAPAZOLE	methimazole	TABLET;ORAL	007517-004	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Qingdao Baheal Pharm	METHIMAZOLE	methimazole	TABLET;ORAL	040547-001	Feb 18, 2005	AB	RX	No	No
Sun Pharm Inds Inc	METHIMAZOLE	methimazole	TABLET;ORAL	040870-001	Sep 25, 2007		DISCN	No	No
Discovery Therap	METHIMAZOLE	methimazole	TABLET;ORAL	040619-003	Jul 12, 2005		DISCN	No	No

Methimazole Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Methimazole

Introduction to Methimazole

Methimazole is a thionamide antithyroid agent that has been a cornerstone in the treatment of hyperthyroidism and hyperparathyroidism since its introduction in 1949. It works by inhibiting the synthesis of thyroid hormones, thereby alleviating the symptoms associated with these conditions[2][4].

Global Market Size and Growth

The global market for methimazole, as part of the broader anti-thyroid drugs market, is experiencing steady growth. The anti-thyroid drugs market is projected to grow from $2.4 billion in 2023 to $2.46 billion in 2024, and further to $2.75 billion by 2028, at a compound annual growth rate (CAGR) of 2.8%[3].

Regional Outlook

The market for methimazole tablets is segmented across various regions, with North America being the largest market in 2023. The Asia-Pacific and Middle East regions are also significant, with the Middle East expected to be the fastest-growing region during the forecast period. The regional market sizes for methimazole tablets are estimated to increase significantly, with the North American market projected to grow from a certain value in 2022 to a higher value by 2028, and the Asia-Pacific market following a similar trend[1][3].

Market Segmentation

The market for methimazole tablets is segmented by type, application, and distribution channel.

By Type

• The primary types of methimazole tablets are 5mg and 10mg. The 5mg segment is expected to grow significantly, driven by its widespread use and preference over other dosages[1].

By Application

• Methimazole tablets are primarily sold through online pharmacies and offline pharmacies. The online pharmacy segment is growing rapidly due to increased consumer preference for online shopping and the convenience it offers[1].

By Distribution Channel

• The distribution channels include wholesalers or distributors, retail chains, online distribution, and other channels. Online distribution is gaining traction due to its ease of access and convenience[3].

Key Players and Market Share

The global methimazole market is dominated by several major manufacturers, including Par Pharmaceutical, Heritage Pharmaceuticals, Sun Pharmaceutical, Abbott, Paladin Pharma, SANDOZ, MedChoice Pharma Tablets, and Johnlee Pharmaceuticals. In 2021, the top three vendors accounted for a significant percentage of the revenue, indicating a competitive but concentrated market[1].

Market Drivers

Several factors are driving the growth of the methimazole market:

Prevalence of Thyroid Disorders

• The increasing prevalence of thyroid disorders such as hyperthyroidism and hyperparathyroidism is a major driver. As more people are diagnosed with these conditions, the demand for effective treatments like methimazole increases[3].

Advancements in Drug Development

• Continuous advancements in drug development and the improvement in healthcare infrastructure also contribute to market growth. New formulations and delivery methods can enhance patient compliance and treatment outcomes[3].

Patient Awareness and Education

• Increased patient awareness and education about thyroid disorders and their treatments are also driving the market. Better informed patients are more likely to seek and adhere to treatment, boosting demand for methimazole[3].

Market Restraints

Despite the growth, the market faces several restraints:

Side Effects

• One of the significant restraints is the side effects associated with methimazole, such as agranulocytosis, severe hepatic toxicity, and other cytopenias. These side effects can limit the use of the drug and impact patient compliance[2][3].

Economic Factors

• Economic factors, including the impact of high inflation, the COVID-19 pandemic, and the Russia-Ukraine war, can also affect the market. These factors can influence healthcare expenditure and patient access to medications[3].

Financial Trajectory

The financial trajectory of the methimazole market is positive, with steady growth projected over the next few years.

Revenue Forecast

• The global methimazole market is expected to see significant revenue growth, with the anti-thyroid drugs market as a whole reaching $2.75 billion by 2028. The North American and Asia-Pacific markets for methimazole tablets are also expected to grow substantially during the forecast period[1][3].

Sales Volume

• The sales volume of methimazole tablets is also anticipated to increase, driven by the growing demand for effective treatments for thyroid disorders. The market size estimations are provided in terms of sales volume (K Units) and revenue ($ millions)[1].

Technological Trends and New Product Developments

The market is also influenced by technological trends and new product developments. For instance, advancements in drug formulation and delivery systems can improve the efficacy and safety of methimazole. Telemedicine and remote monitoring are also becoming more prevalent, which can enhance patient care and compliance with treatment regimens[3].

Competitive Landscape

The competitive landscape of the methimazole market is characterized by a few major players. These companies are focusing on new product developments, expansions, and acquisitions to strengthen their market position. The report provides detailed profiles of key competitors, their market ranks, and their respective market shares, helping stakeholders understand the competitive environment better[1].

Consumer Trends and Behaviors

Consumer trends and behaviors play a crucial role in shaping the methimazole market. Increased patient awareness and education about thyroid disorders and their treatments are driving the demand for methimazole. Additionally, the preference for online shopping and the convenience of online pharmacies are influencing the distribution channels for methimazole tablets[1][3].

Key Takeaways

• The global methimazole market is projected to grow steadily, driven by the prevalence of thyroid disorders and advancements in drug development.
• The market is segmented by type, application, and distribution channel, with online pharmacies and 5mg tablets being significant segments.
• Major manufacturers dominate the market, and new product developments and technological trends are shaping the competitive landscape.
• Side effects and economic factors are key restraints that need to be addressed.
• The financial trajectory is positive, with significant revenue growth expected over the next few years.

FAQs

Q: What is the primary mechanism of action of methimazole? A: Methimazole inhibits the synthesis of thyroid hormones by targeting the enzyme thyroid peroxidase (TPO)[2][4].

Q: Which regions are expected to drive the growth of the methimazole market? A: North America is currently the largest market, but the Middle East is expected to be the fastest-growing region during the forecast period[1][3].

Q: What are the common side effects associated with methimazole? A: Common side effects include agranulocytosis, severe hepatic toxicity, and other cytopenias[2][3].

Q: How is the market for methimazole tablets segmented? A: The market is segmented by type (5mg and 10mg), application (online and offline pharmacies), and distribution channel (wholesalers, retail chains, online distribution)[1][3].

Q: What are the key drivers of the methimazole market? A: The key drivers include the prevalence of thyroid disorders, advancements in drug development, and increased patient awareness and education[3].

Cited Sources

1. Global Methimazole Tablets Market Research Report 2022 - 360 Market Updates
2. Methimazole: Uses, Interactions, Mechanism of Action - DrugBank
3. Anti-Thyroid Drugs Global Market Report 2024 - The Business Research Company
4. Methimazole: Detailed Review on its Transformative R&D Success - Patsnap Synapse