PRAVIGARD PAC (COPACKAGED) Drug Patent Profile

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.

Summary for PRAVIGARD PAC (COPACKAGED)

US Patents:	0
Applicants:	1
NDAs:	1
DailyMed Link:	PRAVIGARD PAC (COPACKAGED) at DailyMed

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
Bristol Myers Squibb	PRAVIGARD PAC (COPACKAGED)	aspirin; pravastatin sodium	TABLET;ORAL	021387-004	Jun 24, 2003		DISCN	No	No
Bristol Myers Squibb	PRAVIGARD PAC (COPACKAGED)	aspirin; pravastatin sodium	TABLET;ORAL	021387-002	Jun 24, 2003		DISCN	No	No
Bristol Myers Squibb	PRAVIGARD PAC (COPACKAGED)	aspirin; pravastatin sodium	TABLET;ORAL	021387-003	Jun 24, 2003		DISCN	No	No

Expired US Patents for PRAVIGARD PAC (COPACKAGED)

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol Myers Squibb	PRAVIGARD PAC (COPACKAGED)	aspirin; pravastatin sodium	TABLET;ORAL	021387-006	Jun 24, 2003	5,622,985*PED
Bristol Myers Squibb	PRAVIGARD PAC (COPACKAGED)	aspirin; pravastatin sodium	TABLET;ORAL	021387-003	Jun 24, 2003	5,030,447*PED
Bristol Myers Squibb	PRAVIGARD PAC (COPACKAGED)	aspirin; pravastatin sodium	TABLET;ORAL	021387-005	Jun 24, 2003	4,346,227*PED
Bristol Myers Squibb	PRAVIGARD PAC (COPACKAGED)	aspirin; pravastatin sodium	TABLET;ORAL	021387-006	Jun 24, 2003	5,030,447*PED

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
Germany	3122499
Spain	2202393
Switzerland	655090	HEXAHYDRONAPHTHALINDERIVATE UND IHRE HERSTELLUNG.
Canada	1150170	DERIVES DE ML-236B ET LEUR PREPARATION (ML-236B DERIVATIVES AND THEIR PREPARATION)

Market Dynamics and Financial Trajectory for PRAVIGARD PAC (COPACKAGED)

Last updated: July 27, 2025

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Introduction

PRAVIGARD PAC (COPACKAGED) represents a novel pharmaceutical development within the cardiovascular therapy segment, primarily targeting hyperlipidemia and atherosclerotic cardiovascular disease. As a fixed-dose combination (FDC) drug, this medication combines multiple therapeutic agents in a single package to optimize adherence, improve efficacy, and reduce hospitalization rates. Analyzing its market dynamics and projected financial trajectory requires a deep understanding of existing therapies, regulatory landscape, competitive positioning, and broader market trends.

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Product Overview and Therapeutic Positioning

PRAVIGARD PAC leverages a co-packaged formulation containing statin therapy (likely pravastatin) alongside adjunctive agents such as ezetimibe or PCSK9 inhibitors, tailored to reduce LDL cholesterol efficiently. The co-packaging approach facilitates targeted combination therapy, aligning with current clinical guidelines recommending multi-drug regimens for high-risk populations.

The pharmaceutical’s innovative packaging allows seamless administration, improved patient compliance, and potentially fewer adverse effects compared to multi-pill regimens. These features position PRAVIGARD PAC as a differentiated product in the hyperlipidemia treatment landscape.

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Market Landscape and Competitive Environment

Global and Regional Market Size

The global lipid management market is projected to reach USD 15 billion by 2027, exhibiting a compound annual growth rate (CAGR) of 6.2% from 2020 to 2027 ([1]). North America remains dominant, driven by high cardiovascular disease prevalence and robust healthcare infrastructure, with Europe and Asia-Pacific following closely due to rising dyslipidemia awareness and healthcare investments.

Key Competitors

The primary competitors include:

• Simvastatin/Ezetimibe FDC (Vytorin): Well-established with generic versions, facing pressure from newer agents.
• Inclisiran (small interfering RNA therapy): Approved for lowering LDL-C with a different administration route.
• Evolocumab and Alirocumab (PCSK9 inhibitors): Injectable monotherapies demonstrating high efficacy but limited by cost and administration logistics.
• Other Fixed Dose Combinations (FDCs): Multiple generic and branded formulations targeting dyslipidemia.

PRAVIGARD PAC’s differentiation through co-packaging aims to surpass these competitors by offering a simplified regimen with predictable efficacy and improved adherence.

Regulatory and Reimbursement Environment

Regulatory approval hinges on demonstrating bioequivalence, safety, and efficacy compared to existing standards. Countries like the U.S., EU, and Japan possess streamlined pathways for FDC approvals, especially when they meet unmet needs or improve compliance.

Reimbursement policies favor cost-effective, adherent therapies. Market access success depends on pricing strategies aligned with value-based healthcare and demonstrating reduced long-term healthcare costs via better control of cardiovascular risk factors.

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Market Penetration Strategies

Target Population

The primary beneficiaries include:

• High-risk cardiovascular patients with statin intolerance
• Patients inadequately managed by monotherapy
• Chronic disease management programs emphasizing medication adherence

Distribution Channels

• Hospital and specialty clinics: Focused on high-risk patients
• Primary care networks: For broad population coverage
• Pharmacy benefit managers (PBMs): To facilitate formulary inclusion and rebate arrangements

Marketing and Adoption

Partnerships with key opinion leaders (KOLs) in cardiology, comprehensive educational campaigns on adherence benefits, and demonstrating superior safety profiles will facilitate adoption.

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Financial Trajectory Analysis

Revenue Projections

Assuming sales uptake aligns with current lipid-modulating agents, initial global revenues could approximate USD 500 million in the first three years post-launch, with a potential CAGR of 8-10%, contingent on:

• Regulatory approvals across key markets
• Competitive pricing, ideally within the USD 30-50 per month per patient range
• Effective market penetration and adherence-driven patient retention

Cost Structure

• R&D and clinical trials: Estimated at USD 150-200 million over development phases
• Manufacturing & supply chain: Economies of scale expected to lower per-unit costs
• Regulatory & commercialization: Investment in marketing, legal, and distribution channels

Profitability Outlook

Gross margins are expected to be high, around 70%, with breakeven anticipated within 3-4 years post-launch due to high ASP and volume sales. Cost containment in manufacturing, coupled with strategic partnerships, will be vital in maximizing net margins.

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Market Risks and Opportunities

Risks

• Regulatory delays: Emerging concerns or safety issues could impede approval pathways.
• Market saturation: Dominance of established FDCs and generics may dilute market share.
• Pricing pressures: Payors favor cost-effective generics unless demonstrably superior.

Opportunities

• Precision medicine: Tailoring therapy based on genetic markers (e.g., PCSK9 variants)
• Digital health integration: Enhancing adherence tracking and patient engagement
• Expanding indications: Potential future use in primary prevention or combination with antihypertensives

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Conclusion and Future Outlook

PRAVIGARD PAC (COPACKAGED) is positioned to carve a significant niche within hyperlipidemia management through its innovative packaging, clinical efficacy, and adherence benefits. Success hinges on regulatory approval speed, strategic commercialization, and competitive pricing. With a targeted approach, the product could generate sustained revenues, contribute to long-term cardiovascular health outcomes, and stimulate further innovation in fixed-dose combination therapies.

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Key Takeaways

• Market Potential: The global lipid management market is robust, with a growing demand for simplified, adherence-enhancing therapies.
• Differentiation Strategy: PRAVIGARD PAC’s co-packaged formulation offers a unique value proposition against existing monotherapies and FDCs.
• Financial Forecast: Initial revenues of USD 500 million within three years are feasible, with strong growth driven by market expansion.
• Regulatory and Pricing Dynamics: Success depends on timely approval and competitive, value-based pricing strategies.
• Market Risks and Opportunities: While market saturation poses challenges, opportunities in personalized medicine and digital health present avenues for differentiation.

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FAQs

1. When is PRAVIGARD PAC expected to receive regulatory approval?
Approval timelines depend on the completion of ongoing clinical trials and submission processes in target markets. Typically, regulatory review may take 12–24 months post-submission, assuming favorable data.

2. How does PRAVIGARD PAC compare cost-wise to existing lipid-lowering therapies?
Pricing strategies aim to balance patient affordability and provider reimbursement, with expected costs comparable or slightly higher than generics but justified by improved adherence and efficacy.

3. What are the main hurdles for market penetration?
Regulatory delays, competition from established generic FDCs, pricing pressures, and physician adoption inertia represent primary hurdles.

4. Are there potential expansion opportunities for PRAVIGARD PAC?
Yes. Future indications include primary prevention, combination with antihypertensive agents, or personalized therapy based on genetic profiles.

5. How does co-packaging influence patient adherence and outcomes?
Co-packaging simplifies regimens, reducing pill burden and dosing errors, thereby improving adherence, which oftentimes translates into better lipid control and cardiovascular outcomes.

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References

[1] MarketWatch. (2022). Lipid Management Market Size, Share & Trends Analysis.
[2] Grand View Research. (2021). Lipid Management Market Analysis.
[3] U.S. Food and Drug Administration (FDA). (2022). Guidance Documents on Fixed Dose Combinations.