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Last Updated: January 5, 2025

TAPAZOLE Drug Patent Profile


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Which patents cover Tapazole, and what generic alternatives are available?

Tapazole is a drug marketed by King Pharms and King Pharms Llc and is included in two NDAs.

The generic ingredient in TAPAZOLE is methimazole. There are three drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the methimazole profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Tapazole

A generic version of TAPAZOLE was approved as methimazole by MYLAN on March 29th, 2000.

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Drug patent expirations by year for TAPAZOLE
Drug Prices for TAPAZOLE

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Recent Clinical Trials for TAPAZOLE

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

SponsorPhase
Case Comprehensive Cancer CenterPhase 2
Emory UniversityEarly Phase 1
University of PisaN/A

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US Patents and Regulatory Information for TAPAZOLE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
King Pharms TAPAZOLE methimazole TABLET;ORAL 007517-002 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
King Pharms Llc TAPAZOLE methimazole TABLET;ORAL 040320-002 Mar 31, 2000 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
King Pharms TAPAZOLE methimazole TABLET;ORAL 007517-004 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
King Pharms Llc TAPAZOLE methimazole TABLET;ORAL 040320-001 Mar 31, 2000 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

TAPAZOLE Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for TAPAZOLE (Methimazole)

Overview of TAPAZOLE

TAPAZOLE, also known as methimazole, is a medication used to treat hyperthyroidism by inhibiting the synthesis of thyroid hormones. It is widely used and has been a staple in the treatment of thyroid disorders for several decades.

Market Size and Growth

The anti-thyroid drugs market, which includes TAPAZOLE, has been experiencing steady growth. As of 2023, the global anti-thyroid drugs market size was valued at $2.4 billion and is expected to grow to $2.46 billion in 2024 at a compound annual growth rate (CAGR) of 2.5%[1].

By 2028, the market is projected to reach $2.75 billion, with a CAGR of 2.8%. This growth is driven by factors such as increasing patient awareness and education, rising healthcare expenditure, and favorable patient demographics[1].

Regional Market Analysis

North America

North America was the largest region in the anti-thyroid drugs market in 2023. This region continues to be a significant market due to advanced healthcare infrastructure and high patient awareness[1].

Middle East

The Middle East is expected to be the fastest-growing region during the forecast period. This growth can be attributed to improving healthcare infrastructure and increasing healthcare expenditure in the region[1].

Other Regions

Other key regions include Asia-Pacific, Western Europe, Eastern Europe, South America, and Africa. Each of these regions has its own market dynamics, with varying growth rates and market sizes[1].

Segmentation by Drug Type

The anti-thyroid drugs market is segmented by drug type, with thionamides (such as methimazole) being a major category. Thionamides work by inhibiting the synthesis of thyroid hormones, making them a crucial component in the treatment of hyperthyroidism[1].

Segmentation by Route of Administration

TAPAZOLE is primarily administered orally, which is the most common route of administration for anti-thyroid drugs. Other routes, such as intravenous, are less common but may be used in specific clinical scenarios[1].

Segmentation by Distribution Channel

The distribution channels for TAPAZOLE include wholesalers or distributors, retail chains, online distribution, and other channels. The retail chain segment is particularly significant due to the widespread availability of these medications in pharmacies and drugstores[1].

Competitive Landscape

The competitive landscape for anti-thyroid drugs, including TAPAZOLE, involves several key players. Companies like Paladin Pharma Inc., which markets TAPAZOLE, play a significant role in the market. Additionally, other pharmaceutical companies such as Takeda Pharmaceutical Co., Ltd., and ASKA Pharmaceutical Holdings Co., Ltd. are also involved in the development and marketing of similar drugs[3][4].

Mechanism of Action and R&D

Methimazole works by inhibiting the enzyme thyroid peroxidase (TPO), which is essential for the synthesis of thyroid hormones. This mechanism makes it an effective treatment for hyperthyroidism. Ongoing research and development (R&D) efforts are focused on improving the efficacy and safety of methimazole and exploring new indications[4].

Safety and Adverse Reactions

While TAPAZOLE is effective, it comes with several potential side effects. These include agranulocytosis, a potentially life-threatening condition, and vasculitis, which can result in severe complications. Patients must be closely monitored for these adverse reactions, and the drug should be discontinued if such conditions arise[2].

Financial Trajectory

The financial trajectory of the anti-thyroid drugs market, including TAPAZOLE, is positive. The market's steady growth is driven by increasing demand and advancements in healthcare infrastructure. Here are some key financial highlights:

  • Market Size: The global anti-thyroid drugs market was valued at $2.4 billion in 2023 and is expected to reach $2.75 billion by 2028[1].
  • Growth Rate: The market is growing at a CAGR of 2.8% from 2023 to 2028[1].
  • Revenue Streams: The revenue is generated through the sales of drugs like methimazole, with values including factory gate values and related services sold by the creators of the goods[1].

Key Trends

Patient-Centric Care

There is a growing trend towards patient-centric care, which includes personalized treatment plans and better patient education. This trend is expected to drive the demand for anti-thyroid drugs like TAPAZOLE[1].

Telemedicine and Remote Monitoring

The integration of telemedicine and remote monitoring is becoming more prevalent, especially post-pandemic. This trend is likely to enhance the accessibility and management of thyroid disorders, thereby influencing the market for anti-thyroid drugs[1].

Alternatives to Traditional Treatments

There is an increasing interest in alternatives to traditional treatments such as thyroid surgery and radioactive iodine. These alternatives may include more advanced pharmaceutical treatments, which could impact the market dynamics for TAPAZOLE[1].

Conclusion

The market for TAPAZOLE and other anti-thyroid drugs is characterized by steady growth driven by increasing patient awareness, advancements in healthcare infrastructure, and favorable patient demographics. The financial trajectory of this market is positive, with a projected growth to $2.75 billion by 2028. However, it is crucial to monitor the safety and efficacy of these drugs to ensure optimal patient outcomes.

Key Takeaways

  • The global anti-thyroid drugs market is expected to grow from $2.4 billion in 2023 to $2.75 billion by 2028.
  • North America is the largest region in the anti-thyroid drugs market, with the Middle East expected to be the fastest-growing region.
  • TAPAZOLE is primarily administered orally and is segmented under thionamides.
  • The competitive landscape includes several key pharmaceutical companies.
  • Ongoing R&D efforts focus on improving the efficacy and safety of methimazole.
  • The drug has potential side effects that require close monitoring.

FAQs

Q: What is the primary mechanism of action of TAPAZOLE?

A: TAPAZOLE works by inhibiting the enzyme thyroid peroxidase (TPO), which is essential for the synthesis of thyroid hormones[4].

Q: What are the potential side effects of TAPAZOLE?

A: Potential side effects include agranulocytosis, vasculitis, and other severe complications. Patients must be closely monitored for these adverse reactions[2].

Q: Which region is expected to be the fastest-growing in the anti-thyroid drugs market?

A: The Middle East is expected to be the fastest-growing region in the anti-thyroid drugs market during the forecast period[1].

Q: How is TAPAZOLE typically administered?

A: TAPAZOLE is primarily administered orally[1].

Q: What is the projected market size of the anti-thyroid drugs market by 2028?

A: The global anti-thyroid drugs market is projected to reach $2.75 billion by 2028[1].

Sources

  1. The Business Research Company: Anti-Thyroid Drugs Global Market Report 2024.
  2. Pfizer: Tapazole® Methimazole Tablets, USP.
  3. Drug and Health Products Portal: TAPAZOLE - Drug and Health Products Portal.
  4. Patsnap Synapse: Methimazole: Detailed Review on its Transformative R&D Success, Mechanism of Action, and Drug Targets.

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