Bepridil hydrochloride - Generic Drug Details

What are the generic drug sources for bepridil hydrochloride and what is the scope of patent protection?

Bepridil hydrochloride is the generic ingredient in two branded drugs marketed by Medpointe Pharm Hlc and Johnson And Johnson, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for bepridil hydrochloride.

Summary for bepridil hydrochloride

US Patents:	0
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	1
Raw Ingredient (Bulk) Api Vendors:	60
Clinical Trials:	2
DailyMed Link:	bepridil hydrochloride at DailyMed

Recent Clinical Trials for bepridil hydrochloride

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

Sponsor	Phase
University of Liverpool	Phase 1
St Stephens Aids Trust	Phase 1
University of Turin, Italy	Phase 1

See all bepridil hydrochloride clinical trials

Medical Subject Heading (MeSH) Categories for bepridil hydrochloride

Anti-Arrhythmia Agents

Antihypertensive Agents

Calcium Channel Blockers

Vasodilator Agents

Anatomical Therapeutic Chemical (ATC) Classes for bepridil hydrochloride

C08EA	Phenylalkylamine derivatives
C08E	NON-SELECTIVE CALCIUM CHANNEL BLOCKERS
C08	CALCIUM CHANNEL BLOCKERS
C	Cardiovascular system

US Patents and Regulatory Information for bepridil hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Johnson And Johnson	VASCOR	bepridil hydrochloride	TABLET;ORAL	019002-001	Dec 28, 1990		DISCN	No	No
Johnson And Johnson	VASCOR	bepridil hydrochloride	TABLET;ORAL	019002-002	Dec 28, 1990		DISCN	No	No
Medpointe Pharm Hlc	BEPADIN	bepridil hydrochloride	TABLET;ORAL	019001-001	Dec 28, 1990		DISCN	No	No
Medpointe Pharm Hlc	BEPADIN	bepridil hydrochloride	TABLET;ORAL	019001-003	Dec 28, 1990		DISCN	No	No
Johnson And Johnson	VASCOR	bepridil hydrochloride	TABLET;ORAL	019002-003	Dec 28, 1990		DISCN	No	No
Medpointe Pharm Hlc	BEPADIN	bepridil hydrochloride	TABLET;ORAL	019001-002	Dec 28, 1990		DISCN	No	No

Expired US Patents for bepridil hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Johnson And Johnson	VASCOR	bepridil hydrochloride	TABLET;ORAL	019002-002	Dec 28, 1990	RE30577
Medpointe Pharm Hlc	BEPADIN	bepridil hydrochloride	TABLET;ORAL	019001-001	Dec 28, 1990	RE30577
Johnson And Johnson	VASCOR	bepridil hydrochloride	TABLET;ORAL	019002-003	Dec 28, 1990	RE30577
Johnson And Johnson	VASCOR	bepridil hydrochloride	TABLET;ORAL	019002-001	Dec 28, 1990	RE30577
Medpointe Pharm Hlc	BEPADIN	bepridil hydrochloride	TABLET;ORAL	019001-003	Dec 28, 1990	RE30577
Medpointe Pharm Hlc	BEPADIN	bepridil hydrochloride	TABLET;ORAL	019001-002	Dec 28, 1990	RE30577

Bepridil hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Bepridil Hydrochloride

Introduction

Bepridil hydrochloride, a calcium channel blocker, was initially developed and marketed for the treatment of angina pectoris. Despite its efficacy in this area, the drug's market dynamics and financial trajectory have been influenced by several factors, including its side effects, regulatory status, and potential new uses.

Historical Use and Approval

Bepridil hydrochloride was approved by the US Food and Drug Administration (FDA) for treating angina pectoris due to its significant anti-anginal activity, which includes coronary vasodilation and modest peripheral effects[2][4].

Market Performance and Sales

In the early stages, bepridil showed promise as an antianginal agent, with efficacy comparable to other calcium channel blockers like nifedipine, verapamil, and diltiazem. It was particularly noted for improving exercise performance in patients with stable angina[3].

However, the drug's market performance was hampered by its association with serious cardiovascular side effects, such as torsades de pointes, a type of ventricular arrhythmia. This led to its withdrawal from the US market[2][4].

Regulatory Status

Bepridil hydrochloride is no longer marketed in the United States due to the risk of ventricular arrhythmias. However, it continues to be used in other countries where the risk-benefit profile is deemed acceptable[1][2].

Financial Impact of Side Effects

The adverse effects associated with bepridil, particularly the risk of torsades de pointes, significantly impacted its financial trajectory. The need for careful patient selection and monitoring, along with the contraindications in certain patient groups, reduced its market share and revenue potential[3][4].

New Potential Uses: Anti-Filovirus Activity

Recent research has identified bepridil as a potent inhibitor of filoviruses, including Ebola and Marburg viruses. This new potential use could revitalize interest in the drug, although it would require careful evaluation of its risk-to-benefit profile in this context[1].

Efficacy in Filovirus Infections

Studies have shown that bepridil demonstrates broad-spectrum anti-filovirus activity, with significant efficacy in both in vitro and in vivo models. For example, in a lethal mouse model of Marburg virus disease, bepridil administration resulted in 80% to 90% survival rates[1].

Market Implications

The discovery of bepridil's anti-filovirus properties opens up new market opportunities, particularly in regions affected by filovirus outbreaks. However, this would necessitate further clinical trials and regulatory approvals to ensure safety and efficacy in human patients.

Competitive Landscape

In the antianginal market, bepridil faces competition from other calcium channel blockers that have fewer side effects. For instance, drugs like nifedipine, verapamil, and diltiazem continue to be widely used without the same level of cardiovascular risk associated with bepridil[3].

Future Prospects

The future financial trajectory of bepridil hydrochloride hinges on several factors:

Clinical Trials and Regulatory Approvals

Further clinical trials are necessary to fully evaluate the safety and efficacy of bepridil in treating filovirus infections. Successful outcomes could lead to new regulatory approvals and a resurgence in market interest.

Drug Development

Efforts to design improved compounds with a similar mechanism but reduced adverse effects could enhance the drug's market potential. This includes developing drugs with better GP-binding properties, which are crucial for inhibiting filovirus replication[1].

Market Expansion

If bepridil or its derivatives gain approval for treating filovirus infections, it could expand into new markets, particularly in regions prone to such outbreaks. This could significantly boost revenue and revitalize the drug's financial trajectory.

Key Takeaways

• Bepridil hydrochloride was initially approved for treating angina but was withdrawn from the US market due to cardiovascular side effects.
• The drug has shown promise in treating filovirus infections, which could open new market opportunities.
• Further clinical trials and regulatory approvals are necessary to fully realize this potential.
• Development of improved compounds with reduced side effects is crucial for long-term market success.

FAQs

Q: What was the original use of bepridil hydrochloride?

A: Bepridil hydrochloride was originally approved for treating angina pectoris due to its anti-anginal properties.

Q: Why was bepridil hydrochloride withdrawn from the US market?

A: Bepridil hydrochloride was withdrawn from the US market due to its association with serious cardiovascular side effects, including torsades de pointes.

Q: What new potential use has been identified for bepridil hydrochloride?

A: Recent research has identified bepridil as a potent inhibitor of filoviruses, including Ebola and Marburg viruses.

Q: What are the implications of bepridil’s anti-filovirus activity for its market prospects?

A: The discovery of bepridil’s anti-filovirus properties opens up new market opportunities, particularly in regions affected by filovirus outbreaks, but requires further clinical trials and regulatory approvals.

Q: What steps are necessary for bepridil to regain market traction?

A: Further clinical trials, regulatory approvals, and the development of improved compounds with reduced adverse effects are necessary for bepridil to regain market traction.

Sources

1. Calcium Channel Blocker Bepridil Demonstrates Efficacy in the Treatment of Filovirus Infections - Journal of Infectious Diseases[1]
2. Bepridil hydrochloride - DrugBank Online[2]
3. Bepridil. A review of its pharmacological properties and therapeutic use - PubMed[3]
4. Bepridil: Uses, Interactions, Mechanism of Action - DrugBank Online[4]