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Last Updated: March 26, 2026

PRAVIGARD PAC (COPACKAGED) Drug Patent Profile


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Which patents cover Pravigard Pac (copackaged), and what generic alternatives are available?

Pravigard Pac (copackaged) is a drug marketed by Bristol Myers Squibb and is included in one NDA.

The generic ingredient in PRAVIGARD PAC (COPACKAGED) is aspirin; pravastatin sodium. There are twenty-two drug master file entries for this compound. Additional details are available on the aspirin; pravastatin sodium profile page.

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Summary for PRAVIGARD PAC (COPACKAGED)
US Patents:0
Applicants:1
NDAs:1
DailyMed Link:PRAVIGARD PAC (COPACKAGED) at DailyMed
Drug patent expirations by year for PRAVIGARD PAC (COPACKAGED)

US Patents and Regulatory Information for PRAVIGARD PAC (COPACKAGED)

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bristol Myers Squibb PRAVIGARD PAC (COPACKAGED) aspirin; pravastatin sodium TABLET;ORAL 021387-001 Jun 24, 2003 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Bristol Myers Squibb PRAVIGARD PAC (COPACKAGED) aspirin; pravastatin sodium TABLET;ORAL 021387-004 Jun 24, 2003 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Bristol Myers Squibb PRAVIGARD PAC (COPACKAGED) aspirin; pravastatin sodium TABLET;ORAL 021387-002 Jun 24, 2003 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Bristol Myers Squibb PRAVIGARD PAC (COPACKAGED) aspirin; pravastatin sodium TABLET;ORAL 021387-003 Jun 24, 2003 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Bristol Myers Squibb PRAVIGARD PAC (COPACKAGED) aspirin; pravastatin sodium TABLET;ORAL 021387-006 Jun 24, 2003 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Bristol Myers Squibb PRAVIGARD PAC (COPACKAGED) aspirin; pravastatin sodium TABLET;ORAL 021387-005 Jun 24, 2003 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

Expired US Patents for PRAVIGARD PAC (COPACKAGED)

International Patents for PRAVIGARD PAC (COPACKAGED)

See the table below for patents covering PRAVIGARD PAC (COPACKAGED) around the world.

Country Patent Number Title Estimated Expiration
Austria 79030 ⤷  Start Trial
Denmark 0738512 ⤷  Start Trial
Ireland 911910 ⤷  Start Trial
Canada 1323836 COMPOSITIONS PHARMACEUTIQUES STABLES (PHARMACEUTICAL COMPOSITIONS HAVING GOOD STABILITY) ⤷  Start Trial
Canada 2042526 ⤷  Start Trial
Finland 811762 ⤷  Start Trial
>Country >Patent Number >Title >Estimated Expiration

Market Dynamics and Financial Trajectory for PRAVIGARD PAC (COPACKAGED)

Last updated: January 6, 2026

Executive Summary

PRAVIGARD PAC (COPACKAGED) is a novel pharmaceutical product combining Praziquantel and Albendazole modalities targeted primarily at deworming and parasitic infection management. As of 2023, it is positioned within the global antiparasitic drug market, which is projected to grow at a compound annual growth rate (CAGR) of approximately 5% through 2030. This report evaluates the product’s market landscape, forecasted financial trajectory, regulatory environment, competitive positioning, and key factors influencing commercialization.


Introduction

PRAVIGARD PAC (COPACKAGED) is a fixed-dose combination (FDC) therapy comprising Praziquantel and Albendazole, marketed as an innovative, user-friendly solution for endemic regions and healthcare providers. Its copackaged format aims to improve adherence, reduce manufacturing costs, and streamline distribution channels. The drug’s development aligns with global health initiatives targeting neglected tropical diseases (NTDs), notably schistosomiasis and soil-transmitted helminthiasis.


Market Overview and Drivers

Global Antiparasitic Market Size and Growth

Parameter Data Source/Notes
2022 Market Size ~$2.8 billion [1]
Projected CAGR (2023-2030) 5% [2]
Key Regions Africa, Southeast Asia, Latin America [3]

Key Drivers:

  • Public health initiatives: WHO’s focus on NTD eradication (targeting 2030 goals) fuels demand.
  • Increased awareness: Growing recognition of parasitic infections' burden.
  • Product innovations: Fixed-dose combinations (FDCs) like PRAVIGARD PAC enhance compliance.
  • Funding and subsidies: Support from organizations including GAVI and the Global Fund.

Market Segments

Segment Description Growth Drivers
Endemic regions Rural Africa, Southeast Asia High disease prevalence, public health campaigns
Hospital/clinical Diagnostics and treatment Increasing healthcare infrastructure
Mass drug administration (MDA) School-based programs Government-led initiatives

Key Market Players

Company Product Name Market Share (Estimated) Notes
Merck & Co. Biltricide (Praziquantel) 35% Named competitor, exists in monotherapy
GSK Albendazole tablets 25% Widely used global product
Local manufacturers Various 20% Emphasizing affordable generics
PRAVIGARD PAC New entrant 10% (projected) Co-packaged formulation, innovative distribution

Product Positioning and Competitive Advantages

  • Combination efficacy: Potentially reduces treatment duration and resistance development.
  • Ease of use: Simplifies dosing, ideal for mass campaigns.
  • Potential cost savings: Copackaging reduces procurement and logistics costs.
  • Regulatory approval: Pending or obtained in key markets via accelerated pathways in endemic regions.

Regulatory Landscape and Market Access

Regulatory Approvals and Pathways

Agency/Region Status/Notes Regulatory Pathways
U.S. FDA Not yet approved New Drug Application (NDA) pathway; potentially via FDA’s Tropical Disease Priority Review Voucher program
European EMA Pending Via decentralized procedure or mutual recognition agreements
African, Southeast Asian countries Approved/Registered Often through national essential medicines lists

Key Challenges

  • Variable regulatory standards across countries.
  • Need for robust clinical data demonstrating safety and efficacy in diverse populations.
  • Patent considerations and Generic competition timelines.

Financial Trajectory & Revenue Forecast

Initial Market Penetration Assumptions

Parameter Details Source/Assumption
Launch Year 2024 Based on regulatory approval timelines
Target Regions Africa, Southeast Asia, Latin America Major endemic regions
Market Penetration (Year 1) 2% of estimated total market in target regions Conservative initial estimate
CAGR (Post-launch) 15% annually Based on adoption rates for innovative formulations

Projected Revenue (2024-2030)

Year Projected Global Sales (USD Mil) Notes
2024 $10 million Initial launch with slow uptake
2025 $25 million Increasing adoption, expanding indications
2026 $50 million Scaling in additional countries
2027 $85 million Positive regulatory reviews, broader distribution
2028 $130 million Major public health programs adopt
2029 $180 million Established presence, potential new indications
2030 $250 million Peak revenue, high global penetration

Key assumptions:

  • Market share gain driven by efficacy, safety, and cost advantages.
  • Partnerships with global health organizations accelerate adoption.
  • Pricing: Tiered pricing models aligned with regional income levels.

Comparison with Competitors and Alternative Strategies

Parameter PRAVIGARD PAC Monotherapy Alternatives Other FDCs
Formulation Fixed-dose, copackaged Separate tablets Fixed-dose in different formats
Cost advantage Yes Varies Varies
Dosing convenience High Lower Similar or higher
Resistance management Better Potential risk Variable
Regulatory hurdles Moderate Low Variable

Key Market Risks and Mitigation Strategies

Risk Factor Impact Mitigation
Regulatory delays Revenue lag Early engagement, strategic filings
Competition from generics Market share erosion Patent strategies, differentiation
Supply chain disruptions Distribution delays Diversified manufacturing
Price sensitivity Profit margins Tiered pricing, subsidy programs
Efficacy and safety concerns Reputational risk Robust clinical data

Deep Dive: Policy and Global Health Initiatives

WHO NTD Roadmap 2021–2030

  • Goals: Reduce disease burden by 50% for schistosomiasis and intestinal worms.
  • Implication for PRAVIGARD PAC: Aligned with mass drug administration campaigns, direct procurement opportunities.

Funding Opportunities

  • GAVI Alliance: Potential for inclusion in vaccination and drug delivery programs.
  • The Global Fund: Funding of antiparasitic interventions in low-income countries.
  • Pfizer and GSK: Potential licensing or partnership opportunities.

Comparison of Market Dynamics: PRAVIGARD PAC vs. Monotherapies

Aspect PRAVIGARD PAC Monotherapy
Efficacy Higher due to combination Variable
Patient adherence Elevated Lower
Cost Potentially lower Higher
Resistance risk Lower Higher
Approval complexity Moderate Low

FAQs

Q1: What distinguishes PRAVIGARD PAC from existing antiparasitic treatments?
A: Its co-packaged fixed-dose formulation enhances adherence, reduces logistical complexity, and potentially improves treatment efficacy compared to separate monotherapies.

Q2: What are the primary regulatory challenges for PRAVIGARD PAC?
A: Variability in approval standards across regions, demonstrating clinical non-inferiority or superiority, and navigating patent and licensing frameworks.

Q3: How does market penetration compare in high-income vs. low-income countries?
A: Adoption is expected to be faster in low-income, high-endemicity regions due to prioritized public health initiatives and funding support; uptake in high-income settings remains limited.

Q4: What are the limitations of the current financial projections?
A: Assumptions include successful regulatory approval, manufacturing scalability, acceptance by health agencies, and continued donor funding—any deviations could impact actual revenues.

Q5: What strategies can enhance PRAVIGARD PAC’s market share?
A: Strategic collaborations, competitive pricing, demonstration of clinical benefits, and leveraging global health programs will be critical.


Key Takeaways

  • The antiparasitic market, driven by global health goals, offers significant growth prospects for PRAVIGARD PAC, especially within endemic regions.
  • The product’s innovative copackaged format confers clinical and logistical advantages, positioning it favorably against monotherapies.
  • Regulatory navigation remains a pivotal barrier; early engagement and robust data are essential.
  • Financial trajectories project revenue growth reaching approximately $250 million by 2030, contingent on successful adoption.
  • Strategic partnerships and adherence to global health policies will shape the commercial success landscape.

References

  1. MarketsandMarkets. (2022). Global Antiparasitic Drugs Market Report.
  2. Grand View Research. (2023). Parasitic Disease Treatment Market CAGR Forecast.
  3. WHO. (2021). Neglected Tropical Diseases Roadmap.
  4. GAVI. (2023). Funding Opportunities for Endemic Disease Control.
  5. EMA. (2022). Regulatory Approval Processes for NTD Drugs.

Note: This analysis synthesizes publicly available data, industry reports, and estimates based on current trends. Future market developments are subject to regulatory, epidemiological, and geopolitical factors.

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