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, Endo Operations, Halsey, Impax Labs, Lilly, Macleods Pharms Ltd, 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:	146
Clinical Trials:	12
Patent Applications:	6,152
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
European Commission	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
Watson Labs	PROPYLTHIOURACIL	propylthiouracil	TABLET;ORAL	080932-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Tablicaps	PROPYLTHIOURACIL	propylthiouracil	TABLET;ORAL	080840-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Ani Pharms	PROPYLTHIOURACIL	propylthiouracil	TABLET;ORAL	080215-001	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

Propylthiouracil Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Propylthiouracil

Introduction to Propylthiouracil

Propylthiouracil (PTU) is an antithyroid medication used primarily to treat hyperthyroidism and Graves' disease. It works by inhibiting the synthesis of thyroid hormones, making it a crucial drug in managing thyroid disorders.

Market Size and Growth

The global propylthiouracil market is anticipated to experience significant growth over the coming years. Here are some key statistics:

• The global propylthiouracil market size is expected to grow from approximately USD 300 million in 2023 to around USD 420 million by 2032, at a compound annual growth rate (CAGR)[4].
• Another forecast indicates that the propylthiouracil market could reach $3,000 million by 2026, growing at a CAGR of 10% from 2021 to 2026[1].

Market Segmentation

The thyroid gland disorder treatment market, which includes propylthiouracil, is segmented in several ways:

• By Drug Type: Propylthiouracil is one of the segments within the broader thyroid gland disorder treatment market, which also includes levothyroxine, liothyronine, imidazole-based compounds, and beta-blockers. The levothyroxine segment dominates this market, but propylthiouracil holds a significant share[3].
• By Disease: The market is segmented into hypothyroidism and hyperthyroidism. Hyperthyroidism, for which propylthiouracil is a treatment, is a substantial segment within this market[3].
• By Route of Administration: The oral route is the most common for propylthiouracil and other thyroid disorder treatments, with this segment anticipated to reach USD 2.4 billion by 2032[3].
• By Distribution Channel: The market is segmented into wholesalers/distributors, retail chains, online distribution, and other channels. Wholesalers/distributors hold a substantial revenue share[3].

Regional Market

Geographically, the thyroid gland disorder treatment market, including propylthiouracil, is diverse but has significant concentrations in certain regions:

• North America: This region held a significant market share of 40.7% in 2023 and is predicted to witness substantial growth over the analysis period[3].

Competitive Landscape

The thyroid gland disorder treatment market, including propylthiouracil, is competitive with several large multinationals and small to mid-sized companies:

• Key market players are focused on developing and launching novel advanced products based on different technologies. This competitive environment drives innovation and market growth[3].

Clinical Use and Recommendations

Treatment of Hyperthyroidism

Propylthiouracil is used to treat hyperthyroidism, a condition where the thyroid gland produces too much thyroid hormone. It is particularly recommended for patients who have not responded well to other treatments like methimazole[2].

Use During Pregnancy

Propylthiouracil is recommended as the first-line treatment for hyperthyroidism during pregnancy due to the potential risks associated with methimazole, such as fetal developmental abnormalities[5].

Side Effects and Precautions

While propylthiouracil is effective, it comes with several potential side effects and precautions:

• Liver Problems: Patients should be monitored for signs of liver problems, such as upper right abdominal pain, dark urine, and yellow eyes or skin[2].
• Blood Cell Count: The drug can lower white blood cell and platelet counts, increasing the risk of infections and bleeding[2].
• Pregnancy and Breastfeeding: Use during pregnancy requires careful monitoring, and while breastfeeding, the drug poses minimal risk to the infant[2].

Technological Advancements

The pharmaceutical industry, including the segment for thyroid disorder treatments, is witnessing significant technological advancements:

• Improved Drug Delivery: Innovations in drug delivery systems are enhancing the bioavailability and efficacy of medications like propylthiouracil[3].
• Targeted Therapies: The development of targeted therapies is another area of advancement, offering more precise and effective treatment options for thyroid disorders[3].

Financial Projections

The financial trajectory for propylthiouracil is positive, driven by several factors:

• Growing Demand: Increasing prevalence of thyroid disorders and the need for effective treatments contribute to the growing demand for propylthiouracil[3].
• Market Expansion: The market is expected to expand due to rising healthcare expenditure globally and increased investment in the diagnosis and treatment of thyroid disorders[3].

Key Takeaways

• The propylthiouracil market is expected to grow significantly, reaching USD 420 million by 2032.
• The drug is a crucial treatment for hyperthyroidism and is particularly recommended during pregnancy.
• The market is segmented by drug type, disease, route of administration, and distribution channel.
• North America holds a significant market share, and technological advancements are driving market growth.
• Careful monitoring is required due to potential side effects, especially liver problems and blood cell count issues.

FAQs

What is propylthiouracil used for?

Propylthiouracil is used to treat hyperthyroidism and Graves' disease by inhibiting the synthesis of thyroid hormones.

Why is propylthiouracil recommended during pregnancy?

Propylthiouracil is recommended during pregnancy because it has a lower risk of fetal developmental abnormalities compared to other antithyroid medications like methimazole.

What are the potential side effects of propylthiouracil?

Potential side effects include liver problems, lowered white blood cell and platelet counts, and various symptoms such as fever, chills, and skin rashes.

How is the propylthiouracil market segmented?

The market is segmented by drug type, disease (hypothyroidism and hyperthyroidism), route of administration (primarily oral), and distribution channel.

What is the projected market size for propylthiouracil by 2032?

The global propylthiouracil market is expected to reach approximately USD 420 million by 2032.

Sources

1. IndustryARC: Propyl Thiouracil Market - Forecast(2024 - 2030) - IndustryARC
2. Mayo Clinic: Propylthiouracil (oral route) - Mayo Clinic
3. GMI Insights: Thyroid Gland Disorder Treatment Market Trends Report, 2032
4. DataIntelo: Propylthiouracil Ptu Market Research Report 2032 - Dataintelo
5. Oxford University Press: Management of Thyroid Dysfunction during Pregnancy and the Postpartum Period - Journal of Clinical Endocrinology & Metabolism[5].