HYDERGINE LC Drug Patent Profile

Which patents cover Hydergine Lc, and what generic alternatives are available?

Hydergine Lc is a drug marketed by Novartis and is included in one NDA.

The generic ingredient in HYDERGINE LC is ergoloid mesylates. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ergoloid mesylates profile page.

Summary for HYDERGINE LC

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
DailyMed Link:	HYDERGINE LC at DailyMed

US Patents and Regulatory Information for HYDERGINE LC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	HYDERGINE LC	ergoloid mesylates	CAPSULE;ORAL	018706-001	Jan 18, 1983		DISCN	No	No

Expired US Patents for HYDERGINE LC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	HYDERGINE LC	ergoloid mesylates	CAPSULE;ORAL	018706-001	Jan 18, 1983	4,366,145

International Patents for HYDERGINE LC

See the table below for patents covering HYDERGINE LC around the world.

Country	Patent Number	Title	Estimated Expiration
Spain	8402504
Spain	513359
Austria	A242282

HYDERGINE LC Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Hydergine LC

Introduction

Hydergine LC, a medication containing ergoloid mesylates, has been on the market for several decades, primarily used for the treatment of senility and cerebrovascular insufficiency. Despite its long history, the drug's market dynamics and financial trajectory have been influenced by various factors, including efficacy concerns, side effects, and broader pharmaceutical market trends.

Historical Context and Approval

Hydergine was first approved by the FDA for the treatment of senility and cerebrovascular insufficiency. However, its use in treating Alzheimer's disease has been a subject of controversy due to limited clinical evidence supporting its efficacy in this area[4].

Efficacy and Clinical Trials

Clinical trials have shown that Hydergine LC is not effective in treating Alzheimer's disease. A notable study revealed that patients treated with Hydergine LC did not perform better than those receiving a placebo and even showed worse performance on some cognitive and behavioral measures[1].

Market Performance and Sales

In the early 1990s, Hydergine saw significant sales, with Sandoz Pharmaceuticals reporting global sales of $199.5 million in 1991, a 5% increase from the previous year. However, the drug's market performance has likely declined since then due to the lack of efficacy in treating Alzheimer's disease and the emergence of more effective treatments for dementia[4].

Side Effects and Safety Profile

Hydergine LC is associated with several side effects, ranging from common issues like dizziness and drowsiness to more severe reactions such as blurred vision, fainting, and stomach cramps. These side effects can impact patient compliance and overall market demand[2].

Global Availability and Prescription Patterns

Hydergine is available in various forms, including liquid-filled capsules, tablets, and solutions. It is prescribed differently in various countries, with some physicians prescribing it to healthy individuals for cognitive enhancement, despite limited evidence supporting such use. The drug's availability through foreign-based mail order businesses and internet suppliers has also been noted[4].

Financial Impact and Pricing

The financial trajectory of Hydergine LC has been influenced by its position in the generic and biosimilar markets. Drugs like Hydergine, which are off-patent and have low prices, often face issues of price erosion. This can lead to reduced profitability, making the market less attractive for manufacturers and increasing the risk of drug shortages[3].

Drug Shortages and Market Sustainability

Drug shortages, particularly affecting off-patent drugs like Hydergine, are becoming more common due to factors such as low prices, market concentration, and supply-side production issues. These shortages can have significant economic and health impacts on patients, further complicating the financial sustainability of such medications[3].

Regulatory and Policy Environment

The FDA has faced pressure to remove Hydergine from the market due to its poor efficacy in treating Alzheimer's disease. Regulatory scrutiny and policy changes aimed at addressing drug shortages and ensuring market sustainability could further impact the drug's financial trajectory[4].

Competitive Landscape

The competitive landscape for dementia treatments has evolved significantly, with newer and more effective drugs such as Butylphthalide, Huperzine A, Edaravone, Rivastigmine, and Memantine gaining prominence. These drugs have better efficacy profiles, making them more attractive to both patients and healthcare providers[5].

Consumer and Healthcare Professional Perceptions

The perception of Hydergine LC among consumers and healthcare professionals is crucial. Given the drug's limited efficacy and side effect profile, it is likely that many prefer alternative treatments. This shift in preference can significantly impact the drug's market dynamics and financial performance.

Future Outlook

The future outlook for Hydergine LC appears challenging. With the availability of more effective treatments, regulatory pressures, and the ongoing issue of drug shortages, the market for Hydergine LC is likely to continue declining. Efforts to address the underlying causes of drug shortages and improve the drug's efficacy profile would be necessary to reverse this trend.

Key Takeaways

• Efficacy Concerns: Hydergine LC has shown limited efficacy in treating Alzheimer's disease.
• Side Effects: The drug is associated with several side effects, impacting patient compliance.
• Market Performance: Sales have likely declined due to efficacy concerns and the emergence of better treatments.
• Regulatory Scrutiny: The FDA has faced pressure to remove Hydergine from the market.
• Drug Shortages: Off-patent drugs like Hydergine face risks of shortages due to low prices and market concentration.
• Competitive Landscape: Newer, more effective drugs are gaining prominence in the dementia treatment market.

FAQs

What is Hydergine LC used for?

Hydergine LC is primarily used for the treatment of senility and cerebrovascular insufficiency, although it has been promoted for other uses such as cognitive enhancement.

Is Hydergine LC effective in treating Alzheimer's disease?

No, clinical trials have shown that Hydergine LC is not effective in treating Alzheimer's disease and may even perform worse than placebo on some cognitive and behavioral measures[1].

What are the common side effects of Hydergine LC?

Common side effects include dizziness, drowsiness, skin rash, and slow pulse. More severe side effects can include blurred vision, fainting, and stomach cramps[2].

Why are there drug shortages of Hydergine LC?

Drug shortages of Hydergine LC are often due to low prices, market concentration, and supply-side production issues, making the market less attractive for manufacturers[3].

What are the alternatives to Hydergine LC for dementia treatment?

Alternatives include more effective drugs such as Butylphthalide, Huperzine A, Edaravone, Rivastigmine, and Memantine, which have better efficacy profiles for treating dementia[5].

How has the regulatory environment impacted Hydergine LC?

The FDA has faced pressure to remove Hydergine from the market due to its poor efficacy in treating Alzheimer's disease, adding to the regulatory scrutiny the drug faces[4].

Sources

1. Lack of efficacy of hydergine in patients with Alzheimer's disease - PubMed
2. Hydergine LC Side Effects - Drugs.com
3. The Dynamics of Drug Shortages - Office of Health Economics
4. Nomination Background: Hydergine - National Toxicology Program
5. Pharmacological treatments for vascular dementia: a systematic review - Frontiers in Pharmacology