HYDERGINE Drug Patent Profile

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

Hydergine is a drug marketed by Novartis and is included in four NDAs.

The generic ingredient in HYDERGINE 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

US Patents:	0
Applicants:	1
NDAs:	4
Raw Ingredient (Bulk) Api Vendors:	15
Patent Applications:	105
DailyMed Link:	HYDERGINE at DailyMed

US Patents and Regulatory Information for HYDERGINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	HYDERGINE	ergoloid mesylates	SOLUTION;ORAL	018418-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Novartis	HYDERGINE	ergoloid mesylates	TABLET;SUBLINGUAL	009087-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Novartis	HYDERGINE	ergoloid mesylates	TABLET;ORAL	017993-003	Approved Prior to Jan 1, 1982		DISCN	No	No

Expired US Patents for HYDERGINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	HYDERGINE	ergoloid mesylates	SOLUTION;ORAL	018418-001	Approved Prior to Jan 1, 1982	4,138,565

International Patents for HYDERGINE

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

Country	Patent Number	Title	Estimated Expiration
Czechoslovakia	205023	PROCESS FOR PREPARING STABLE SOLUTIONS OF HYDROGENATED ERGOT ALKALOIDS
Yugoslavia	133076
Sweden	426782	SETT ATT FRAMSTELLA STABILA LOSNINGAR AV HYDRERADE MJOLDRYGEALKALOIDER, DERAS SYNTETISKA DERIVAT ELLER DERAS SALTER

HYDERGINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Hydergine

Introduction

Hydergine, also known as ergoloid mesylates, is a prescription drug used primarily for the treatment of senility and cerebrovascular insufficiency. Here, we will delve into the market dynamics and financial trajectory of Hydergine, exploring its historical sales, usage patterns, and the challenges it faces in the pharmaceutical market.

Historical Sales and Market Presence

In the early 1990s, Hydergine was a significant player in the pharmaceutical market. Sandoz Pharmaceuticals, the manufacturer, reported global sales of $199.5 million in 1991, representing a 5% increase from the previous year[1].

Use Patterns and Indications

Hydergine is approved by the FDA for the treatment of senility and cerebrovascular insufficiency. However, its use extends beyond these indications, particularly in other countries where it is prescribed to healthy individuals to enhance intelligence and memory. The drug is available in various forms, including liquid-filled capsules, tablets, and solutions, with dosages ranging from 0.5 mg to 12 mg per day[1][4].

Clinical Efficacy and Limitations

The clinical efficacy of Hydergine is modest, particularly in the treatment of Alzheimer’s disease. Studies have shown that while Hydergine may provide some symptomatic relief, its benefits are more pronounced in behavioral rather than cognitive measures. The drug has shown better efficacy in treating vascular dementia compared to Alzheimer’s[1].

Market Challenges

Despite its historical sales, Hydergine faces significant challenges in the market. The FDA has been pressured to remove Hydergine from the market due to its limited efficacy in treating Alzheimer’s. Additionally, the drug's market presence is affected by the availability of other nootropics and cognitive enhancers, which are often promoted through non-traditional channels such as the internet[1].

Global Sales and Revenue

The global sales of Hydergine peaked in the early 1990s but have since declined due to various factors, including regulatory pressures and the emergence of more effective treatments. The exact current revenue figures for Hydergine are not readily available, but it is clear that the drug's market share has diminished over the years[1].

Regulatory Environment

Hydergine is not listed in the EPA’s Toxic Substances Control Act Inventory, and its use is regulated by the FDA. However, the drug's availability through foreign-based mail order businesses and internet suppliers complicates its regulatory landscape[1].

Pharmacokinetics and Bioavailability

Pharmacokinetic studies have shown that Hydergine is rapidly absorbed from the gastrointestinal tract, with peak plasma levels achieved within 1.5 to 3 hours. However, the bioavailability of the drug is limited due to significant first-pass liver metabolism, resulting in less than 50% of the therapeutic moiety reaching the systemic circulation[4].

Financial Trajectory

The financial trajectory of Hydergine is marked by declining sales and revenue. The high development costs and low success rates of pharmaceuticals, as seen in the broader industry, also impact Hydergine. The average cost of bringing a new drug to market is about $2.6 billion, with a development timeline spanning 10 to 15 years and a success rate of only around 10%[3].

Comparison with Other Pharmaceutical Trends

In contrast to blockbuster drugs like AbbVie's Humira, which generated over $20 billion in annual revenue at its peak, Hydergine's revenue is significantly lower. The pharmaceutical market's shift towards addressing unmet medical needs, particularly in areas like oncology and diabetes, further marginalizes drugs like Hydergine that do not offer groundbreaking therapeutic benefits[3].

Future Outlook

Given the current market dynamics and the declining financial trajectory, the future outlook for Hydergine appears challenging. The drug's limited efficacy, regulatory pressures, and the emergence of more effective treatments suggest that its market presence will continue to diminish.

Key Takeaways

• Historical Sales: Hydergine had significant global sales in the early 1990s but has since declined.
• Use Patterns: The drug is used for senility and cerebrovascular insufficiency, with additional off-label use for cognitive enhancement.
• Clinical Efficacy: Modest benefits, particularly in vascular dementia, but limited efficacy in Alzheimer’s.
• Market Challenges: Regulatory pressures, availability of alternative treatments, and declining market share.
• Financial Trajectory: Declining sales and revenue, impacted by high development costs and low success rates in the pharmaceutical industry.

FAQs

1. What is Hydergine used for? Hydergine is primarily used for the treatment of senility and cerebrovascular insufficiency. It is also promoted as a cognitive enhancer for healthy individuals.

2. What are the clinical benefits of Hydergine? Hydergine provides modest symptomatic relief, particularly in vascular dementia. However, its benefits in treating Alzheimer’s are limited and more behavioral than cognitive.

3. Why is Hydergine facing market challenges? Hydergine faces challenges due to its limited efficacy, regulatory pressures, and the availability of more effective treatments.

4. How is Hydergine administered? Hydergine is available in various forms, including liquid-filled capsules, tablets, and solutions, with dosages ranging from 0.5 mg to 12 mg per day.

5. What is the current market status of Hydergine? The current market status of Hydergine is declining, with reduced sales and revenue due to the factors mentioned above.

Sources

1. Nomination Background: Hydergine CASRN 8067-24-1 - National Toxicology Program
2. Financing the Clean Hydrogen Revolution - Hydrogen Council
3. Investment Trends in Pharmaceutical Research - DrugBank Blog
4. Hydergine: Package Insert / Prescribing Information - Drugs.com
5. Scaling Hydrogen Financing for Development - OECD