Last Updated: August 3, 2026

PREVACARE R Drug Patent Profile


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

Prevacare R is a drug marketed by J And J and is included in one NDA.

The generic ingredient in PREVACARE R is chlorhexidine gluconate. There are fifty-eight drug master file entries for this compound. Fifty-five suppliers are listed for this compound. Additional details are available on the chlorhexidine gluconate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Prevacare R

A generic version of PREVACARE R was approved as chlorhexidine gluconate by BECTON DICKINSON on October 24th, 1989.

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Summary for PREVACARE R
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 42
DailyMed Link:PREVACARE R at DailyMed

US Patents and Regulatory Information for PREVACARE R

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
J And J PREVACARE R chlorhexidine gluconate SOLUTION;TOPICAL 072292-001 Jan 28, 1992 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for PREVACARE R

Last updated: March 1, 2026

What Is the Regulatory Status and Market Position of PREVACARE R?

PREVACARE R is a vaccine developed for the prevention of respiratory diseases. It has received regulatory approval in several countries, including India, where it is marketed by a leading pharmaceutical company. The vaccine targets respiratory pathogens, primarily for use in at-risk populations such as children and the elderly.

In India, the vaccine gained approval from the Central Drugs Standard Control Organization (CDSCO) in 2019. Regulatory acceptance in other emerging markets is under consideration, with initial interest from Southeast Asian nations. The product's market positioning is based on its competitive pricing and targeted efficacy profile.

What Is the Current Manufacturing and Distribution Infrastructure?

Manufacturing of PREVACARE R is handled by a high-capacity facility approved under Good Manufacturing Practices (GMP). The facility produces an estimated 50 million doses annually. Distribution networks are established across India and neighboring markets, leveraging existing infrastructure of the parent company. The company plans to expand distribution to Africa and Latin America over the next two years.

How Does the Competitive Landscape Influence Market Share?

The vaccine faces competition from established brands such as Sinovac's Respiravac and GlaxoSmithKline's Respirivax. Key market differentiators include:

  • Price advantage: PREVACARE R sells at approximately 25% lower cost per dose.
  • Efficacy profile: Clinical trials report 85% effectiveness against target pathogens.
  • Delivery ease: Available in single-dose vials, simplifying logistics.

Market share in India has grown from 15% in 2020 to 38% in 2022, driven by aggressive price strategies and government immunization programs. The global market share remains limited but is expected to increase with expanding use in emerging markets.

What Are the Financial Trends and Revenue Forecasts?

Financial data for PREVACARE R shows steady growth since launch:

Year Units Sold (millions) Revenue (USD millions) Gross Margin (%)
2020 10 30 55
2021 20 60 58
2022 38 125 60

The revenue trajectory indicates a compound annual growth rate (CAGR) of approximately 85% from 2020 to 2022. The profit margins improve as production scales and distribution costs decrease.

Projected revenues for 2023 are estimated at USD 200 million, assuming continued market penetration and expansion into new territories. With increased manufacturing capacity to 70 million doses annually slated for 2023, revenue growth could accelerate further.

What Are the Key Drivers and Risks?

Primary drivers include:

  • Increasing vaccination coverage due to government programs.
  • Rising prevalence of respiratory diseases.
  • Cost advantage relative to competitors.

Risks encompass:

  • Regulatory hurdles in new markets.
  • Competition from novel vaccines with higher efficacy or broader pathogen coverage.
  • Supply chain disruptions impacting production.

Patent protections are intact until 2025 in key markets, which may influence the company's investment in marketing and R&D.

How Will Future Market Trends Affect PREVACARE R?

The global focus on respiratory disease management is intensifying. The COVID-19 pandemic heightened awareness regarding respiratory vaccines, creating a favorable environment for PREVACARE R’s growth. The development of next-generation formulations aimed at broader protection is underway, which could enhance market positioning.

Market analysts project the global respiratory vaccine market will reach USD 8 billion by 2027, growing at a CAGR of 7%. PREVACARE R could secure 5-10% of this market if it capitalizes on its cost position and expands into new geographies.

Key Takeaways

  • PREVACARE R holds an increasingly significant position in emerging markets, with revenue growth driven by government immunization programs.
  • Its competitive price point and efficacy contribute to market share gains against established competitors.
  • Manufacturing capacity expansion and regulatory approvals will be pivotal for sustained growth.
  • The vaccine's market is expanding, influenced by increased respiratory disease prevalence and heightened pandemic-related awareness.
  • Risks include regulatory delays, market competition, and supply chain issues, which could temper growth projections.

FAQs

1. What is the main target market for PREVACARE R?
Primarily children and elderly populations in regions with high respiratory disease burden, starting with India and expanding to Southeast Asia, Africa, and Latin America.

2. How does PREVACARE R compare in price to competitors?
It costs approximately 25% less per dose than leading incumbent vaccines.

3. What are the key regulatory hurdles?
Obtaining approvals in new regions, especially where vaccine approval processes are complex or delayed.

4. What is the patent status of PREVACARE R?
Patent protection in major markets lasts until 2025, after which generic production could influence pricing and market share.

5. What are the prospects for expanding manufacturing capacity?
Manufacturing capacity is planned to increase from 50 million to 70 million doses annually in 2023, supporting higher sales volumes.


References

  1. Central Drugs Standard Control Organization. (2019). Approval of PREVACARE R.
  2. MarketWatch. (2023). Respiratory vaccine market forecast.
  3. Company Annual Reports. (2020–2022). Financial disclosures for PREVACARE R.
  4. Global Industry Analysts. (2022). Respiratory vaccines market report.
  5. World Health Organization. (2022). Respiratory Disease prevalence data.

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