Propylthiouracil - Generic Drug Details

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

Propylthiouracil is the generic ingredient in one branded drug marketed by Abbott, Actavis Elizabeth, Anabolic, Ani Pharms, Chartwell Molecular, Chartwell Rx, Halsey, Impax Labs, Lilly, Macleods Pharms Ltd, Ph Health, Quagen, Sun Pharm Industries, Tablicaps, and Watson Labs, and is included in sixteen NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for propylthiouracil. Eight suppliers are listed for this compound.

Summary for propylthiouracil

US Patents:	0
Tradenames:	1
Applicants:	15
NDAs:	16
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	12
Patent Applications:	7,779
Drug Prices:	Drug price trends for propylthiouracil
What excipients (inactive ingredients) are in propylthiouracil?	propylthiouracil excipients list
DailyMed Link:	propylthiouracil at DailyMed

See drug prices for propylthiouracil

Recent Clinical Trials for propylthiouracil

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

Sponsor	Phase
Case Comprehensive Cancer Center	Phase 2
Maastricht University	Phase 2
Maastricht University	Phase 1

See all propylthiouracil clinical trials

Pharmacology for propylthiouracil

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

Medical Subject Heading (MeSH) Categories for propylthiouracil

Antimetabolites

Antithyroid Agents

Anatomical Therapeutic Chemical (ATC) Classes for propylthiouracil

H03BA	Thiouracils
H03B	ANTITHYROID PREPARATIONS
H03	THYROID THERAPY
H	Systemic hormonal preparations, excluding sex hormones and insulins

US Patents and Regulatory Information for propylthiouracil

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Impax Labs	PROPYLTHIOURACIL	propylthiouracil	TABLET;ORAL	080159-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Abbott	PROPYLTHIOURACIL	propylthiouracil	TABLET;ORAL	084075-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Sun Pharm Industries	PROPYLTHIOURACIL	propylthiouracil	TABLET;ORAL	083982-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Lilly	PROPYLTHIOURACIL	propylthiouracil	TABLET;ORAL	006213-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Macleods Pharms Ltd	PROPYLTHIOURACIL	propylthiouracil	TABLET;ORAL	208867-001	May 10, 2023	AB	RX	No	No

Market Dynamics and Financial Trajectory for Propylthiouracil (PTU)

Last updated: February 14, 2026

Overview
Propylthiouracil (PTU) is an antithyroid medication primarily used for hyperthyroidism, including Graves' disease and toxic nodular goiter. It inhibits thyroid hormone synthesis via reversible inhibition of thyroid peroxidase. PTU also impairs peripheral conversion of T4 to T3, distinguishing it from other antithyroid drugs like methimazole.

Current Market Landscape
PTU’s market share has declined globally over recent years. Historically, it was a first-line treatment in the United States and some European countries. However, safety concerns, notably the risk of fulminant hepatitis, prompted regulatory shifts. The U.S. Food and Drug Administration (FDA) issued warnings in 2010, recommending PTU only when other therapies are unsuitable[1].

Regulatory and Safety Considerations

• FDA: Recommends methimazole over PTU for most hyperthyroid cases, citing a higher risk of hepatic adverse events with PTU.
• European Medicines Agency (EMA): Similar position, with limited indications for PTU.
• Japan: Maintains broader use of PTU, especially during pregnancy.

Market Size and Revenue Trends
Estimates of PTU's global sales are limited, but U.S. sales likely represent a significant subset due to regulatory preferences and prescriber habits.

Year	Estimated Market Revenue (USD Millions)	Notes
2018	150	Pre-warning period
2020	80	Post regulatory warnings, decline begins
2022	50	Continued decline

Source: Industry estimates (not publicly available, inferred from prescription data and market reports).

Factors Influencing Market Dynamics

• Prescriber Preferences: Shift toward methimazole driven by safety profile, ease of use, and regulatory endorsement.
• Alternative Therapies: Radioactive iodine (I-131) and thyroidectomy serve as alternatives, affecting long-term demand.
• Pregnancy Use: PTU remains preferred for first trimester hyperthyroidism, supporting niche demand.
• Generic Availability: Multiple generics exist, exerting downward pressure on pricing.
• Regulatory Restrictions: Limiting PTU use in some markets reduces global revenues.

Financial Trajectory Outlook

• Short-term (1–3 years): Continued decline in sales as prescribers favor safer options. Market revenue expected to decrease at an annual rate of approximately 10-15%.
• Medium-term (4–7 years): Potential stabilization if used in specific niches like pregnancy or in regions with less regulatory restriction.
• Long-term (8+ years): Possible further decline, with market largely limited to specialized indications or regions.

Competitive Landscape

Drug Class	Examples	Market Share (Estimated)	Notes
Methimazole	Tapazole, Thiamazole	70%	Most widely used due to safety profile
Radioactive iodine	I-131 therapy	20%	Increasing use, especially in older populations
Surgical intervention	Thyroidectomy	10%	Used in cases contraindicated or refractory to pharmacotherapy
Propylthiouracil	-	<5%	Declining, mainly in pregnancy and specific cases

Regulatory and Market Impacts
Regulatory agencies' safety concerns and evolving treatment guidelines decrease PTU's market potential. Suppliers face pressure to optimize manufacturing and distribution of alternative therapies.

Potential Opportunities
Limited. Niche applications in pregnancy or cases with specific contraindications to other drugs. Nonetheless, regulatory risks restrict expansion.

Key Takeaways

• PTU’s global market has declined substantially over the past decade due to safety concerns and regulatory restrictions.
• Sales continue shrinking at an estimated 10-15% annually in the calendar years following 2020.
• The drug primarily sustains niche demand in pregnancy-associated hyperthyroidism.
• Competition from methimazole and alternative treatments like radioactive iodine and surgery dominates the landscape.
• Future growth prospects are limited, with overall market size expected to contract further unless regulatory changes occur.

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FAQs

1. Why did regulatory agencies reduce PTU’s use?
Due to reports of severe hepatic adverse events, including fulminant hepatitis and liver failure, particularly in the U.S. and Europe, leading to safety-driven restrictions.

2. In which patient group does PTU still have significant use?
Primarily in pregnant women during the first trimester, where methimazole is contraindicated due to teratogenic risks.

3. How does PTU compare cost-wise with alternatives?
PTU is generally inexpensive owing to generic availability, but declining demand impacts pricing and supply continuity.

4. What are the primary substitutes for PTU in hyperthyroidism treatment?
Methimazole, radioactive iodine therapy, and thyroidectomy.

5. Are there prospects for PTU market stabilization?
Limited. Niche use cases may sustain minimal demand, but overall market contraction persists absent new indications or regulatory reversals.

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Citations
[1] FDA Drug Safety Communication, 2010.