METHIMAZOLE - Generic Drug Details

What are the generic sources for methimazole and what is the scope of patent protection?

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

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

Summary for METHIMAZOLE

US Patents:	0
Tradenames:	2
Applicants:	12
NDAs:	12
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	20
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	23
Patent Applications:	5,294
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
Worg Biotherapeutics Inc.	PHASE2
Case Comprehensive Cancer Center	Phase 2
The First Affiliated Hospital of Xiamen University	Phase 2/Phase 3

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
Macleods Pharms Ltd	METHIMAZOLE	methimazole	TABLET;ORAL	209827-002	May 24, 2023	AB	RX	No	No
King Pharms	TAPAZOLE	methimazole	TABLET;ORAL	007517-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No
King Pharms	TAPAZOLE	methimazole	TABLET;ORAL	007517-004	Approved Prior to Jan 1, 1982		DISCN	Yes	No
King Pharms Llc	TAPAZOLE	methimazole	TABLET;ORAL	040320-001	Mar 31, 2000		DISCN	No	No
Sun Pharm Inds Inc	METHIMAZOLE	methimazole	TABLET;ORAL	040870-001	Sep 25, 2007		DISCN	No	No
Mylan	METHIMAZOLE	methimazole	TABLET;ORAL	040350-003	Jun 7, 2001		DISCN	No	No

Market Dynamics and Financial Trajectory of Methimazole

Last updated: February 3, 2026

Summary

Methimazole is a widely used antithyroid medication indicated primarily for the treatment of hyperthyroidism, notably Graves' disease. This analysis examines current market trends, competitive landscape, regulatory environment, pricing, and future financial projections. Key factors influencing its market include rising prevalence of thyroid disorders, evolving treatment guidelines, and competitive pressures. Despite generic availability, strategic considerations around patent expirations and emerging therapies shape its financial trajectory.

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Introduction to Methimazole

Drug Profile

Attribute	Details
Chemical Name	1-methylethyl thiocarbonyl imidazole (Methimazole)
Therapeutic Class	Thionamide (antithyroid)
Indications	Hyperthyroidism, Graves' disease
Administration	Oral
Patent Status	Off-patent (generic availability since 1990s)
Market Status	Established generic medication

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Market Dynamics

Demand Drivers

Factor	Impact	Evidence / Data
Rising incidence of thyroid disorders	Increased prescription volume	WHO estimates ~5 million cases of hyperthyroidism globally (2021) [1]
Aging population	Greater prevalence in elderly	Data indicate higher hyperthyroidism prevalence among seniors [2]
Enhanced disease awareness	Higher diagnosis rates	Improved screening and patient education initiatives
Favorable treatment profile (oral, low side effects)	Preferred treatment choice	Clinical guidelines favor methimazole over propylthiouracil [3]

Supply Chain Factors

Aspect	Influence
Manufacturing capacity	Steady supply, low cost production
Global distribution channels	Expanding into emerging markets
Raw material sourcing	Potential vulnerability affecting prices

Regulatory and Policy Environment

Policy Element	Effect	Notes
Generic drug approval pathways	Accelerates market entry	Supports widespread availability
Essential medicines designation	Encourages affordability	WHO inclusion: Essential medicines list (EML) [4]
Price regulation and reimbursement policies	Influences margins	Variable across regions (e.g., US, EU, Asia)

Competitive Landscape

Competitors	Market Share (Estimate)	Key Differentiators
Generic manufacturers (e.g., Teva, Sandoz)	>90%	Cost competitiveness, wide availability
Brand-name alternatives	Minor niche players	Slight differences in formulation or packaging

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Pricing Trends and Revenue Estimates

Current Pricing Overview

Region	Approximate Wholesale Price (per 5mg tablet)	Notes
United States	$0.02 - $0.05	Highly competitive, volume-driven
European Union	€0.03 - €0.07	Pricing influenced by healthcare policies
Asia-Pacific	$0.01 - $0.04	Lower production costs, emerging markets growth

Revenue Projections (2023–2028)

Year	Estimated Global Market Revenue	Key Assumptions
2023	~$500 million	Stable demand, competitive generic pricing
2024	~$550 million	Slight increase due to aging demographics
2025	~$600 million	Integration of emerging markets
2026	~$650 million	Continued growth, new healthcare policies
2027	~$700 million	Possible product diversification or combo approaches
2028	~$750 million	Market maturation, stable demand

Note: These figures are estimates based on current trends, disease prevalence, and market penetration.

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Emerging Trends and Constraints

Therapeutic Innovations

• New Antithyroid Drugs: Innovations have produced alternative therapies, but none have significantly displaced methimazole.
• Radioactive Iodine Therapy & Surgery: Complementary or replacement options in certain cases; impact on drug sales minimal.

Regulatory Challenges

• Safety Concerns: Rare adverse events (agranulocytosis) impact prescribing behavior.
• Regulatory Revisions: Updated guidelines may influence prescribing patterns but are unlikely to endanger existing market share.

Market Entry Barriers

• Patent Expiry: No patent restrictions in most markets for decades.
• Manufacturing Costs & Quality Standards: Stringent standards limit new entrants to established players.

Potential Risks

Risk Type	Description
Market saturation	Limited growth potential due to widespread generic availability
Competition from newer therapies	E.g., monoclonal antibodies or novel targeted treatments
Regulatory changes	Price control measures, stricter safety monitoring

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Comparison with Alternative Therapies

Therapy	Mechanism	Advantages	Limitations
Propylthiouracil (PTU)	Thionamide, inhibits hormone synthesis	Usable in pregnancy	Liver toxicity risk
Radioactive Iodine (RAI)	Ablates overactive thyroid tissue	One-time treatment	Delayed effect, potential hypothyroidism
Surgical Thyroidectomy	Physical removal of gland	Rapid relief	Surgical risks, recovery time

Regulatory Landscape and Patent Outlook

Region	Patent Status	Regulatory Highlights
US	Off-patent since 1990s	FDA approves generics; Compulsory licensing possible
EU	Off-patent	EMA approval of generics; pricing managed under national policies
Asia-Pacific	Varies by country	Patent laws differ; generics prevalent, price competition fierce

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Future Financial Trajectory and Strategies

Forecast Drivers

• Aging population increases hyperthyroidism cases worldwide.
• Expansion into emerging markets widens access and volume.
• Generics sustain low-cost, high-volume sales.

Potential Growth Strategies

Strategy	Description
Geographic expansion	Focus on Asia, Africa with high prevalence of thyroid disorders
Pricing Optimization	Negotiating bulk procurement deals with health authorities
Formulation Innovation	Developing combination products or sustained-release forms
Market Education & Patient Outreach	Increase awareness and compliance to grow prescription rates

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Key Takeaways

• Methimazole remains the dominant, low-cost, globally accessible treatment for hyperthyroidism.
• Market growth is driven by increasing disease prevalence, with stable demand forecasted for the next five years.
• The generic status of methimazole limits price volatility but necessitates cost leadership and efficiency.
• Competition from newer therapies exists but has yet to significantly impact market share.
• Regulatory and safety considerations influence market dynamics but are unlikely to negate existing demand.
• Entry barriers are relatively high due to manufacturing standards and established supplier dominance.
• Emerging markets present substantial growth opportunities through increased adoption and healthcare infrastructure development.

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FAQs

1. What factors could significantly alter the financial trajectory of methimazole?

Changes in safety profiles, regulatory price controls, the emergence of superior therapies, or shifts in disease prevalence could impact revenue streams. For example, a breakthrough targeted therapy could reduce reliance on methimazole.

2. How does the patent landscape impact current market security for methimazole?

Since off-patent since the 1990s, no patent protections restrict manufacturing. This fosters competition, keeping prices low but also limiting exclusivity-driven revenue growth.

3. What regional differences affect the availability and pricing of methimazole?

Regulatory policies, healthcare infrastructure, and economic status influence availability. For instance, the US and EU have strict safety and quality standards, whereas some emerging markets may have variances that affect pricing and supply.

4. Are there any upcoming regulatory changes likely to influence the market?

Potential safety updates or guidelines, especially regarding rare side effects, could impact prescribing habits. Price regulation initiatives in certain jurisdictions could also influence profitability.

5. What is the outlook for generic manufacturers in the methimazole market?

They are poised to maintain a significant share due to minimal patent restrictions. Success depends on manufacturing efficiency, quality assurance, and expanding into untapped markets.

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References

[1] WHO, Thyroid Disorders Prevalence, 2021.
[2] American Thyroid Association, Hyperthyroidism Demographics, 2020.
[3] Clinical Practice Guidelines for Hyperthyroidism Management, 2021.
[4] World Health Organization, List of Essential Medicines, 2022.