PERMAX Drug Patent Profile

When do Permax patents expire, and what generic alternatives are available?

Permax is a drug marketed by Valeant Pharm Intl and is included in one NDA.

The generic ingredient in PERMAX is pergolide mesylate. There are four drug master file entries for this compound. Additional details are available on the pergolide mesylate profile page.

Summary for PERMAX

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	101
Clinical Trials:	1
Patent Applications:	3,902
DailyMed Link:	PERMAX at DailyMed

Recent Clinical Trials for PERMAX

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

Sponsor	Phase
Colorado Neurology	Phase 3
Agarwal, Pinky, M.D.	Phase 3
GlaxoSmithKline	Phase 3

See all PERMAX clinical trials

US Patents and Regulatory Information for PERMAX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Valeant Pharm Intl	PERMAX	pergolide mesylate	TABLET;ORAL	019385-001	Dec 30, 1988		DISCN	No	No
Valeant Pharm Intl	PERMAX	pergolide mesylate	TABLET;ORAL	019385-002	Dec 30, 1988		DISCN	No	No
Valeant Pharm Intl	PERMAX	pergolide mesylate	TABLET;ORAL	019385-003	Dec 30, 1988		DISCN	No	No

Expired US Patents for PERMAX

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	4,180,582
Valeant Pharm Intl	PERMAX	pergolide mesylate	TABLET;ORAL	019385-002	Dec 30, 1988	4,166,182
Valeant Pharm Intl	PERMAX	pergolide mesylate	TABLET;ORAL	019385-003	Dec 30, 1988	4,166,182
Valeant Pharm Intl	PERMAX	pergolide mesylate	TABLET;ORAL	019385-001	Dec 30, 1988	4,166,182
Valeant Pharm Intl	PERMAX	pergolide mesylate	TABLET;ORAL	019385-002	Dec 30, 1988	4,797,405
Valeant Pharm Intl	PERMAX	pergolide mesylate	TABLET;ORAL	019385-003	Dec 30, 1988	4,797,405

International Patents for PERMAX

See the table below for patents covering PERMAX around the world.

Country	Patent Number	Title	Estimated Expiration
German Democratic Republic	141928	VERFAHREN ZUR HERSTELLUNG NEUER ERGOLINDERIVATE
Austria	79258
Romania	81857	PROCEDEU DE PREPARARE A UNOR 6-N-PROPIL-8-METOXIMETILERGOLINE SAU 6-N-PROPIL- 8-METILMERCAPTOMETILERGOLINE (PROCESS FOR THE PREPARATION OF 6-N-PROPYL-8-METHOXYMETHYLERGOLINES OR 6-N-PROPYL-8-METHYLMERCAPTOMETHYL-ERGOLINES)
South Africa	7900453
New Zealand	226650	LIGHT-STABILISED PHARMACEUTICAL COMPOSITIONS CONTAINING PERGOLIDE AND A STABILISING AGENT
Czechoslovakia	203951	METHOD OF PREPARING ERGOLINE DERIVATIVES

Supplementary Protection Certificates for PERMAX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0003667	SPC/GB93/063	United Kingdom		SPC/GB93/063, EXPIRES: 20040204

PERMAX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: Permax

Introduction

Permax, known generically as pergolide mesylate, was a dopamine agonist used primarily to treat Parkinson's disease. Here, we will delve into the market dynamics and financial trajectory of this drug, highlighting its rise, challenges, and eventual withdrawal from the market.

Market Entry and Initial Success

Permax was originally brought to market by Eli Lilly but was later marketed in the United States by Valeant Pharmaceuticals International and in Canada by Shire[1][4].

Therapeutic Use

Permax belonged to a class of drugs called dopamine agonists, which stimulate the brain's production of the neurotransmitter dopamine. This made it a valuable treatment option for patients with Parkinson's disease, although it was not the primary treatment for the condition[1].

Market Presence

Despite not being the main treatment for Parkinson's, Permax had a significant presence in the market. In Canada, for example, there were nearly 21,000 prescriptions for the medication in the year preceding its withdrawal[1].

Financial Performance

The financial performance of Permax was tied to the overall revenue of its marketing companies. For instance, Valeant Pharmaceuticals, which marketed Permax in the U.S., reported substantial revenue growth in its specialty pharmaceuticals segment. However, the specific financial contributions of Permax to Valeant's revenue are not detailed in available reports[2].

Regulatory Challenges and Safety Concerns

The market dynamics for Permax took a significant turn with the emergence of serious safety concerns. Studies published in January 2007 revealed a higher-than-anticipated risk of valvular heart disease associated with pergolide. These findings led to the voluntary withdrawal of Permax from the market in both Canada and the U.S.[1][4].

Impact of Withdrawal

The withdrawal of Permax had immediate and long-term implications for both patients and the pharmaceutical industry. Patients were advised not to stop taking the drug abruptly and to consult their doctors for safe alternatives. Other dopamine agonists were recommended as substitutes, indicating that the market had alternatives to fill the gap left by Permax[1].

Financial Consequences

The withdrawal of Permax likely had financial repercussions for Valeant Pharmaceuticals and Shire, although specific figures are not publicly disclosed. The loss of a marketed product would typically result in reduced revenue and potential legal liabilities, especially if patients or their families pursued legal action due to the drug's side effects.

Impact on Equine Medicine

Interestingly, the withdrawal of Permax also affected the equine industry, as pergolide was used to treat horses with pituitary pars intermedia dysfunction (equine Cushing's disease). Veterinarians expressed concerns about the availability of the drug for veterinary use, highlighting the need for an approved veterinary product to replace it[4].

Market Adaptation

The pharmaceutical industry adapted quickly to the withdrawal of Permax. Other companies and compounding pharmacies began exploring alternatives, including the potential development of new products specifically labeled for veterinary use. This adaptation underscores the dynamic nature of the pharmaceutical market, where companies must be ready to respond to regulatory changes and safety concerns[4].

Lessons Learned

The case of Permax highlights several key lessons for the pharmaceutical industry:

• Safety First: The primary concern for any pharmaceutical product is patient safety. The withdrawal of Permax due to heart valve risks underscores the importance of continuous monitoring and rigorous safety studies.
• Regulatory Compliance: Companies must be prepared to comply with regulatory requirements and respond swiftly to safety concerns raised by regulatory bodies.
• Market Adaptability: The industry's ability to adapt to changes, such as the development of alternative treatments, is crucial for maintaining market presence and patient trust.

Key Takeaways

• Permax was a dopamine agonist used to treat Parkinson's disease but was withdrawn due to serious heart valve risks.
• The drug's market presence was significant, but its withdrawal had immediate financial and therapeutic implications.
• The pharmaceutical industry's response to the withdrawal included finding alternative treatments and exploring new product developments.
• Patient safety and regulatory compliance are paramount in the pharmaceutical market.

FAQs

What was Permax used to treat?

Permax, or pergolide mesylate, was used to treat Parkinson's disease by stimulating the brain's production of dopamine.

Why was Permax withdrawn from the market?

Permax was withdrawn due to the risk of serious damage to heart valves, as confirmed by several studies.

Which companies marketed Permax?

Permax was originally brought to market by Eli Lilly but was later marketed in the U.S. by Valeant Pharmaceuticals International and in Canada by Shire.

How did the withdrawal affect the equine industry?

The withdrawal of Permax affected the equine industry because pergolide was also used to treat horses with pituitary pars intermedia dysfunction (equine Cushing's disease).

What alternatives were recommended for patients taking Permax?

Patients were advised to switch to other dopamine agonists under the guidance of their doctors to avoid abrupt cessation of the drug.

Sources

1. CBC News: Parkinson's drug withdrawn
2. Valeant Annual Report 2010: The future is clear
3. PwC: Pharma 2020: Marketing the future
4. AVMA: FDA announces voluntary withdrawal of pergolide
5. Eli Lilly and Company: Financial results and product pipeline developments