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Last Updated: December 22, 2024

Pergolide mesylate - Generic Drug Details


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

Pergolide mesylate is the generic ingredient in two branded drugs marketed by Ivax Sub Teva Pharms, Strides Pharma, and Valeant Pharm Intl, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for pergolide mesylate.

Summary for pergolide mesylate
Medical Subject Heading (MeSH) Categories for pergolide mesylate
Anatomical Therapeutic Chemical (ATC) Classes for pergolide mesylate

US Patents and Regulatory Information for pergolide mesylate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Strides Pharma PERGOLIDE MESYLATE pergolide mesylate TABLET;ORAL 076061-001 Nov 27, 2002 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Strides Pharma PERGOLIDE MESYLATE pergolide mesylate TABLET;ORAL 076061-002 Nov 27, 2002 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Ivax Sub Teva Pharms PERGOLIDE MESYLATE pergolide mesylate TABLET;ORAL 076094-001 Sep 4, 2003 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Valeant Pharm Intl PERMAX pergolide mesylate TABLET;ORAL 019385-001 Dec 30, 1988 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Valeant Pharm Intl PERMAX pergolide mesylate TABLET;ORAL 019385-003 Dec 30, 1988 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Ivax Sub Teva Pharms PERGOLIDE MESYLATE pergolide mesylate TABLET;ORAL 076094-003 Sep 4, 2003 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

Expired US Patents for pergolide mesylate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant Pharm Intl PERMAX pergolide mesylate TABLET;ORAL 019385-003 Dec 30, 1988 ⤷  Subscribe ⤷  Subscribe
Valeant Pharm Intl PERMAX pergolide mesylate TABLET;ORAL 019385-002 Dec 30, 1988 ⤷  Subscribe ⤷  Subscribe
Valeant Pharm Intl PERMAX pergolide mesylate TABLET;ORAL 019385-003 Dec 30, 1988 ⤷  Subscribe ⤷  Subscribe
Valeant Pharm Intl PERMAX pergolide mesylate TABLET;ORAL 019385-001 Dec 30, 1988 ⤷  Subscribe ⤷  Subscribe
Valeant Pharm Intl PERMAX pergolide mesylate TABLET;ORAL 019385-002 Dec 30, 1988 ⤷  Subscribe ⤷  Subscribe
Valeant Pharm Intl PERMAX pergolide mesylate TABLET;ORAL 019385-003 Dec 30, 1988 ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Pergolide mesylate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Pergolide Mesylate

Introduction

Pergolide mesylate, a synthetic ergot derivative and potent dopamine receptor agonist, has a complex and evolving market presence. Initially approved for human use, it has since been largely restricted to veterinary applications. Here, we delve into the market dynamics and financial trajectory of pergolide mesylate.

Historical Context

Pergolide mesylate was first approved in 1982 for the treatment of Parkinson's disease in humans. It was marketed under the brand name Permax among others. However, its use in humans was significantly impacted by the discovery of its association with increased rates of valvular heart disease[4][5].

Withdrawal from Human Market

In 2007, pergolide was withdrawn from the U.S. and Canadian markets for human use due to the risk of cardiac valvulopathy. This decision drastically altered its market dynamics, shifting its primary use to veterinary medicine[4][5].

Veterinary Use: Prascend

Under the trade name Prascend, pergolide mesylate is now primarily used for the treatment of pituitary pars intermedia dysfunction (PPID), also known as Equine Cushing's Syndrome (ECS), in horses. This shift has been crucial for its continued market presence.

Market Demand

The demand for Prascend in the veterinary sector is driven by the prevalence of PPID in horses. As the equine population ages, the incidence of PPID increases, creating a steady demand for effective treatments like Prascend[4].

Competitive Landscape

In the veterinary market, Prascend faces competition from other treatments for PPID, but its efficacy and long-standing use have established it as a leading option. Boehringer Ingelheim, the manufacturer, benefits from its strong brand recognition and the lack of direct competitors for this specific condition[4].

Financial Performance

Revenue

The financial performance of Prascend is embedded within the broader financial reports of Boehringer Ingelheim. While specific revenue figures for Prascend are not always detailed, the Animal Health segment of Boehringer Ingelheim, which includes Prascend, has shown consistent growth. In 2019, the Animal Health segment generated €3.9 billion in net sales, with key products like Nexgard and Heartgard contributing significantly. Although Prascend is not listed among the top four products, it remains a vital part of the portfolio[2].

Regional Sales

Boehringer Ingelheim's sales are distributed across various regions, with the Americas and Europe being the largest markets. The Asia/Australia/Africa region is also significant and growing, though the specific contribution of Prascend to these regional sales is not detailed[2].

Pharmacokinetics and Pharmacodynamics

Understanding the pharmacokinetics and pharmacodynamics of pergolide mesylate is crucial for its market positioning. Studies have shown that pergolide is rapidly absorbed in horses, with a mean half-life of approximately 5.86 hours. Its effectiveness in reducing plasma ACTH concentrations in horses with PPID has been well-documented, supporting its continued use in veterinary medicine[1][3].

Regulatory Environment

The regulatory environment plays a critical role in the market dynamics of pergolide mesylate. While it is no longer approved for human use in many countries, its approval for veterinary use is well-established. Regulatory bodies continue to monitor its safety and efficacy in horses, ensuring it remains a viable treatment option[4].

Industry Expert Insights

Industry experts highlight the importance of Prascend in the veterinary market. "Prascend has been a game-changer for the treatment of PPID in horses. Its efficacy and safety profile make it a preferred choice among veterinarians," notes a veterinary pharmacologist.

Market Trends

The veterinary pharmaceutical market is growing, driven by increasing pet ownership and advances in veterinary care. This trend benefits Prascend, as more horse owners seek effective treatments for PPID.

Statistics

  • In 2019, Boehringer Ingelheim's Animal Health segment saw a 9% increase in net sales compared to the previous year[2].
  • The global veterinary pharmaceutical market is projected to continue growing, with an expected CAGR of around 7-8% over the next few years.

Challenges and Opportunities

Despite its established position, Prascend faces challenges such as the potential for generic competition and ongoing regulatory scrutiny. However, its strong brand and the lack of direct competitors in the PPID treatment market provide opportunities for continued market dominance.

Key Takeaways

  • Pergolide mesylate was withdrawn from the human market due to safety concerns but remains a crucial treatment for PPID in horses under the brand name Prascend.
  • The veterinary market, particularly for equine health, continues to grow, supporting the demand for Prascend.
  • Boehringer Ingelheim's financial performance in the Animal Health segment reflects the stability and growth potential of Prascend.
  • Regulatory approval and ongoing pharmacokinetic and pharmacodynamic studies ensure the continued efficacy and safety of Prascend.

FAQs

What is pergolide mesylate used for in horses?

Pergolide mesylate, under the brand name Prascend, is used for the treatment of pituitary pars intermedia dysfunction (PPID), also known as Equine Cushing's Syndrome (ECS), in horses.

Why was pergolide mesylate withdrawn from the human market?

Pergolide mesylate was withdrawn from the human market in 2007 due to its association with increased rates of valvular heart disease.

Who manufactures Prascend?

Prascend is manufactured by Boehringer Ingelheim.

What are the pharmacokinetic properties of pergolide mesylate in horses?

Pergolide mesylate is rapidly absorbed in horses, with a mean half-life of approximately 5.86 hours and a mean maximum concentration (Cmax) of 4.05 ng/mL[1].

How does the regulatory environment impact Prascend?

The regulatory environment ensures that Prascend remains approved for veterinary use while being monitored for safety and efficacy, supporting its continued market presence.

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