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Last Updated: December 22, 2024

PROCANBID Drug Patent Profile


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

Procanbid is a drug marketed by King Pharms and is included in one NDA.

The generic ingredient in PROCANBID is procainamide hydrochloride. There are nine drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the procainamide hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Procanbid

A generic version of PROCANBID was approved as procainamide hydrochloride by INTL MEDICATION on July 31st, 1984.

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Summary for PROCANBID
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 119
Patent Applications: 1,306
DailyMed Link:PROCANBID at DailyMed
Drug patent expirations by year for PROCANBID

US Patents and Regulatory Information for PROCANBID

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
King Pharms PROCANBID procainamide hydrochloride TABLET, EXTENDED RELEASE;ORAL 020545-002 Jan 31, 1996 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
King Pharms PROCANBID procainamide hydrochloride TABLET, EXTENDED RELEASE;ORAL 020545-001 Jan 31, 1996 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for PROCANBID

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
King Pharms PROCANBID procainamide hydrochloride TABLET, EXTENDED RELEASE;ORAL 020545-002 Jan 31, 1996 5,656,296 ⤷  Subscribe
King Pharms PROCANBID procainamide hydrochloride TABLET, EXTENDED RELEASE;ORAL 020545-001 Jan 31, 1996 5,656,296 ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

PROCANBID Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Procanbid

Introduction

Procanbid, a sustained-release formulation of procainamide hydrochloride, is a Class 1A antiarrhythmic agent used to treat various cardiac arrhythmias. To understand the market dynamics and financial trajectory of Procanbid, it is essential to delve into its pharmacological profile, market trends, and the financial health of the companies involved in its production and distribution.

Pharmacological Profile of Procanbid

Mechanism of Action

Procanbid works as a sodium channel blocker in cardiomyocytes, which helps in treating symptomatic ventricular premature depolarizations (VPD), nonsustained ventricular tachycardia, and life-threatening ventricular arrhythmias[1][4].

Administration and Pharmacokinetics

Procanbid is administered orally and has a bioavailability of 85%. It is metabolized in the liver, primarily by the CYP2D6 enzyme, and its major metabolite is N-acetylprocainamide (NAPA). The elimination half-life of procainamide is approximately 2.5 to 4.5 hours[4].

Market Trends for Antiarrhythmic Drugs

Global Market Outlook

The broader market for antiarrhythmic drugs is part of the larger cardiovascular therapeutic market. While specific data on Procanbid's market share is limited, the overall market for cardiovascular drugs is significant and growing. For instance, the global market for therapeutic monoclonal antibodies, which includes some antiarrhythmic treatments, is expected to grow substantially, though Procanbid itself is not an antibody-based drug[3].

Competitive Landscape

Procanbid competes with other antiarrhythmic agents such as quinidine, propranolol, lidocaine, and diphenylhydantoin. The approval of extended-release formulations like Procanbid has improved patient compliance by reducing the frequency of dosing, which can be a competitive advantage[1][4].

Financial Trajectory of Procaps Group

Company Overview

Procaps Group (NASDAQ: PROC), a company involved in the production and distribution of Procanbid, has been undergoing significant financial and governance changes.

Recent Financial Developments

  • Financing and Debt Restructuring: Procaps Group has secured up to $40 million in convertible notes financing from Hoche Partners Pharma Holdings, with an initial $20 million note issued at an 8.50% annual interest rate. This move is part of a broader effort to restructure the company's debt, including the cancellation of a $5 million junior unsecured subordinated note and a reduction of $2.2 million in accounts payable[2].
  • Forbearance Agreements: The company has extended forbearance agreements covering approximately $209 million of financial indebtedness until January 31, 2025. This extension is crucial for the company's financial stability during its restructuring phase[2].

Governance Changes

  • Board Updates: Procaps Group has announced significant governance changes, including the appointment of Alejandro Weinstein as Chairman and the addition of four new directors following the December 16, 2024 Annual General Meeting. These changes reflect a major overhaul of corporate oversight aimed at improving strategic direction and financial management[2].

Financial Stability

Despite the efforts to secure financing and restructure debt, Procaps Group faces significant financial challenges. The company's ability to pay its suppliers is in question, and the risk of default under its loan obligations is a pressing concern. The withdrawal of Hoche's financing offer due to unrealistic counter-offers from majority shareholders has further complicated the situation[5].

Impact on Procanbid's Market Dynamics

Supply Chain Stability

The financial instability of Procaps Group could impact the supply chain and availability of Procanbid. If the company is unable to pay its suppliers, it may lead to production delays or shortages, affecting patient access to the medication.

Market Perception

The governance changes and financial restructuring efforts may influence market perception of Procaps Group and its products, including Procanbid. A stable and well-governed company is more likely to maintain market trust and attract investors.

Competitive Advantage

Despite these challenges, the unique formulation of Procanbid, allowing for twice-daily dosing, remains a competitive advantage. This convenience can continue to attract patients and healthcare providers, provided the supply chain remains intact.

Key Takeaways

  • Pharmacological Profile: Procanbid is an effective antiarrhythmic agent with a sustained-release formulation.
  • Market Trends: The broader market for antiarrhythmic drugs is competitive but growing.
  • Financial Trajectory: Procaps Group faces significant financial challenges but is undergoing restructuring efforts to improve stability.
  • Governance Changes: The company has made substantial governance changes to enhance oversight and strategic direction.
  • Supply Chain Risks: Financial instability could impact the supply chain and availability of Procanbid.

FAQs

What is Procanbid used for?

Procanbid is used to treat symptomatic ventricular premature depolarizations (VPD), nonsustained ventricular tachycardia, and life-threatening ventricular arrhythmias.

How is Procanbid administered?

Procanbid is administered orally, typically in a sustained-release formulation allowing for twice-daily dosing.

What are the key financial challenges facing Procaps Group?

Procaps Group is dealing with significant debt, including $209 million under forbearance agreements, and has struggled to secure stable financing to avoid default on its loan obligations.

How do governance changes affect Procanbid's market dynamics?

The appointment of new directors and a new Chairman at Procaps Group aims to improve corporate governance and strategic direction, which can positively impact market trust and stability for Procanbid.

What are the potential risks to Procanbid's supply chain?

The financial instability of Procaps Group could lead to production delays or shortages if the company is unable to pay its suppliers.

Sources

  1. Effect of age, gender, and race on steady state procainamide... - PubMed
  2. Procaps Group Announces Financing, Shareholders Agreement and Board Updates - Stock Titan
  3. Antibody Drugs: Technologies and Global Markets - BCC Research
  4. Procainamide - Wikipedia
  5. Form SC 13D/A for Procaps Group SA filed 10/28/2024 - Procaps Group Investor Relations

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