BENZGALANTAMINE GLUCONATE - Generic Drug Details

What are the generic drug sources for benzgalantamine gluconate and what is the scope of freedom to operate?

Benzgalantamine gluconate is the generic ingredient in one branded drug marketed by Alpha Cognition and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Benzgalantamine gluconate has twenty-four patent family members in seventeen countries.

One supplier is listed for this compound.

Summary for BENZGALANTAMINE GLUCONATE

International Patents:	24
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
DailyMed Link:	BENZGALANTAMINE GLUCONATE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for BENZGALANTAMINE GLUCONATE

Constraining patent/regulatory exclusivity:

9,763,953

Dosage:

TABLET, DELAYED RELEASE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Anatomical Therapeutic Chemical (ATC) Classes for BENZGALANTAMINE GLUCONATE

N06DA	Anticholinesterases
N06D	ANTI-DEMENTIA DRUGS
N06	PSYCHOANALEPTICS
N	Nervous system

US Patents and Regulatory Information for BENZGALANTAMINE GLUCONATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alpha Cognition	ZUNVEYL	benzgalantamine gluconate	TABLET, DELAYED RELEASE;ORAL	218549-002	Jul 26, 2024		RX	Yes	No	9,763,953
Alpha Cognition	ZUNVEYL	benzgalantamine gluconate	TABLET, DELAYED RELEASE;ORAL	218549-003	Jul 26, 2024		RX	Yes	No	11,795,176			Y
Alpha Cognition	ZUNVEYL	benzgalantamine gluconate	TABLET, DELAYED RELEASE;ORAL	218549-001	Jul 26, 2024		RX	Yes	Yes	11,795,176			Y
Alpha Cognition	ZUNVEYL	benzgalantamine gluconate	TABLET, DELAYED RELEASE;ORAL	218549-002	Jul 26, 2024		RX	Yes	No	11,795,176			Y
Alpha Cognition	ZUNVEYL	benzgalantamine gluconate	TABLET, DELAYED RELEASE;ORAL	218549-003	Jul 26, 2024		RX	Yes	No	9,763,953
Alpha Cognition	ZUNVEYL	benzgalantamine gluconate	TABLET, DELAYED RELEASE;ORAL	218549-001	Jul 26, 2024		RX	Yes	Yes	9,763,953

International Patents for BENZGALANTAMINE GLUCONATE

Country	Patent Number	Title	Estimated Expiration
Cyprus	1110822
China	101287719	Cholinergic enhancers with improved blood-brain barrier permeability for the treatment of diseases accompanied by cognitive impairment
China	116761612	α-1062葡糖酸盐的固体形式 (Solid forms of alpha-1062 gluconate)
Spain	2348334
Canada	2623114	AMPLIFICATEURS CHOLINERGIQUES DE PERMEABILITE DE LA BARRIERE SANG-CERVEAU AMELIOREE POUR LE TRAITEMENT DE MALADIES ACCOMPAGNEES D'UNE DEFICIENCE COGNITIVE (CHOLINERGIC ENHANCERS WITH IMPROVED BLOOD-BRAIN BARRIER PERMEABILITY FOR THE TREATMENT OF DISEASES ACCOMPANIED BY COGNITIVE IMPAIRMENT)
World Intellectual Property Organization (WIPO)	2007039138
European Patent Office	1777222	Inhibiteurs de la cholinesterase avec une perméabilité améliorée de la barrière ématoencéphalique pour le traitement de troubles cognitifs (Cholinergic enhancers with improved blood-brain barrier permeability for the treatment of diseases accompanied by cognitive impairment)

BENZGALANTAMINE GLUCONATE Market Analysis and Financial Projection Experimental

Benzgalantamine Gluconate: Market Dynamics and Financial Trajectory

Introduction

Benzgalantamine gluconate, marketed as ZUNVEYL, is a prodrug of galantamine, indicated for the treatment of mild to moderate dementia of the Alzheimer's type. Developed by Alpha Cognition, this drug is poised to enter a market characterized by high dissatisfaction with current treatments due to adverse events and limited efficacy.

Market Need and Opportunity

The Alzheimer's disease (AD) market is significant, with approximately 11 million prescriptions for acetylcholinesterase inhibitors (AChEIs) dispensed annually in the US. However, this market is marked by high discontinuation rates due to side effects, creating a substantial opportunity for improved treatment options[1].

Unmet Medical Needs

Current AChEIs, such as donepezil, galantamine, and rivastigmine, while effective, often come with gastrointestinal side effects, which are a major reason for treatment discontinuation. Benzgalantamine gluconate is designed to optimize the efficacious dose while minimizing treatment-limiting side effects, addressing this unmet need[1].

Competitive Landscape

The AD market has seen several blockbuster drugs, including Aricept, Exelon, and Namzaric, which have achieved significant sales despite generic competition. For instance, Namzaric, a 505(b)(2) treatment for moderate-to-severe AD, has delivered over $200 million in yearly sales without differentiation or promotion since 2018[1].

Market Potential

Benzgalantamine gluconate, if approved, would be the second oral treatment for Alzheimer’s disease approved in the last 10 years. Given its unique design as a prodrug of galantamine, it has the potential to capture a significant share of the market. The drug's ability to circulate with greater bioavailability and minimize side effects positions it as a best-in-class treatment[1].

Financial Trajectory

Research and Development Expenses

Alpha Cognition has invested significantly in the research and development of benzgalantamine gluconate. In 2023, R&D expenses were $1.3 million for the three months ended June 30, and $2.4 million for the six months ended June 30, reflecting a decrease from the prior year due to the completion of main clinical trials and NDA filing expenditures[2].

Funding and Private Placements

To support the advancement of clinical development programs and the filing of the New Drug Application (NDA) for benzgalantamine gluconate, Alpha Cognition has secured substantial funding through private placements. In 2023, the company raised a total of $6,055,650 through two tranches of private placements[2].

Commercialization Plans

Alpha Cognition plans to focus its initial go-to-market commercial efforts on the long-term care (LTC) market, which accounts for 36% of total market prescriptions. This strategy is expected to provide an initial commercial opportunity valued at $2 billion, with future expansion into the neurology market valued at $1.7 billion[1].

Regulatory Status and Approval Timeline

The NDA for benzgalantamine gluconate was submitted to the FDA in September 2023 and accepted in December 2023. The drug is on track for approval in the third quarter of 2024, with commercialization targeted for the first quarter of 2025[2].

Patent Protection

Benzgalantamine gluconate has been granted patent protection through 2042, with additional patent filings planned for 2024. This extensive patent protection will help maintain market exclusivity and protect the drug's revenue potential[1].

Clinical and Pharmacological Profile

Mechanism of Action

Benzgalantamine gluconate acts as a prodrug of galantamine, an acetylcholinesterase inhibitor and nicotinic receptor modulator. The formation of the benzoyl ester eliminates acetylcholinesterase inhibition until the drug is metabolized, reducing side effects. The gluconate salt increases solubility, enhancing bioavailability[1][4].

Clinical Trials and Efficacy

Clinical trials have demonstrated that galantamine, the active metabolite of benzgalantamine gluconate, has multiple beneficial effects, including improved memory and attention, anti-inflammatory effects, and a significantly lower risk of death. These trials have also shown a strong effect on cognitive decline and a reduction in the risk of developing dementia[1].

Adverse Effects and Safety Profile

While benzgalantamine gluconate is designed to minimize side effects, it still carries risks associated with cholinesterase inhibitors. These include cardiovascular effects such as bradycardia and AV block, gastrointestinal symptoms like nausea and diarrhea, and potential genitourinary issues such as bladder outflow obstruction. Dosage adjustments are recommended for patients with renal impairment[4].

Market Forecast and Revenue Potential

Market Size and Growth

The US market for Alzheimer’s disease treatments is valued at $5.5 billion, with a significant portion of this market being dissatisfied with current treatments. Given its unique profile, benzgalantamine gluconate is expected to capture a substantial share of this market, particularly in the LTC segment where branded medications are more commonly used[1].

Sales Projections

If approved, benzgalantamine gluconate could achieve significant sales, potentially rivaling or surpassing the peak sales of other successful AD treatments. For example, Exelon Patch achieved $650 million in peak sales despite being in a fully generic market, highlighting the potential for benzgalantamine gluconate to achieve blockbuster status[1].

Key Takeaways

• Market Opportunity: High dissatisfaction with current AD treatments creates a significant market opportunity for benzgalantamine gluconate.
• Unique Mechanism: The drug's prodrug design minimizes side effects and enhances bioavailability.
• Regulatory Status: NDA submitted and accepted, with approval targeted for Q3 2024 and commercialization in Q1 2025.
• Financial Trajectory: Substantial funding secured through private placements; commercial focus on LTC market initially.
• Clinical Profile: Demonstrated efficacy in improving memory and attention, with a strong safety profile compared to existing treatments.

FAQs

What is benzgalantamine gluconate used for?

Benzgalantamine gluconate is indicated for the treatment of mild to moderate dementia of the Alzheimer's type in adults[4].

How does benzgalantamine gluconate differ from other Alzheimer’s treatments?

It is a prodrug of galantamine, designed to minimize side effects and enhance bioavailability through its unique benzoyl ester and gluconate salt formulation[1].

What is the current regulatory status of benzgalantamine gluconate?

The NDA was submitted in September 2023 and accepted by the FDA in December 2023, with approval targeted for the third quarter of 2024[2].

What are the potential side effects of benzgalantamine gluconate?

Common side effects include nausea, vomiting, diarrhea, dizziness, and headache. It also carries risks of cardiovascular and genitourinary issues[4].

What is the market potential for benzgalantamine gluconate?

Given its unique profile and the high dissatisfaction with current treatments, benzgalantamine gluconate has the potential to achieve significant sales, particularly in the LTC market[1].

Sources

1. Alpha Cognition Corporate Presentation. Alpha Cognition, 2021.
2. Alpha Cognition Announces Financial Results for the Second Quarter and Six Months Ended June 2024. Businesswire, August 12, 2024.
3. Benzgalantamine by AlphaCognition for Alzheimer's Disease. Pharmaceutical Technology, August 28, 2024.
4. Benzgalantamine Gluconate Monograph for Professionals. Drugs.com, October 10, 2024.
5. Benzgalantamine - AlphaCognition. AdisInsight - Springer, October 17, 2024.