PRIMACOR Drug Patent Profile

When do Primacor patents expire, and when can generic versions of Primacor launch?

Primacor is a drug marketed by Sanofi Aventis Us and is included in two NDAs.

The generic ingredient in PRIMACOR is milrinone lactate. There are nine drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the milrinone lactate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Primacor

A generic version of PRIMACOR was approved as milrinone lactate by FRESENIUS KABI USA on May 28^th, 2002.

Summary for PRIMACOR

US Patents:	0
Applicants:	1
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	102
Clinical Trials:	11
Patent Applications:	5,982
DailyMed Link:	PRIMACOR at DailyMed

Recent Clinical Trials for PRIMACOR

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

Sponsor	Phase
Mahidol University	Phase 2
Zagazig University	Phase 4
University of Kansas Medical Center	Phase 1

See all PRIMACOR clinical trials

US Patents and Regulatory Information for PRIMACOR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sanofi Aventis Us	PRIMACOR	milrinone lactate	INJECTABLE;INJECTION	019436-001	Dec 31, 1987		DISCN	Yes	No
Sanofi Aventis Us	PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER	milrinone lactate	INJECTABLE;INJECTION	020343-003	Aug 9, 1994		DISCN	Yes	No
Sanofi Aventis Us	PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER	milrinone lactate	INJECTABLE;INJECTION	020343-001	Aug 9, 1994		DISCN	Yes	No
Sanofi Aventis Us	PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER	milrinone lactate	INJECTABLE;INJECTION	020343-002	Aug 9, 1994		DISCN	Yes	No

Expired US Patents for PRIMACOR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi Aventis Us	PRIMACOR	milrinone lactate	INJECTABLE;INJECTION	019436-001	Dec 31, 1987

International Patents for PRIMACOR

See the table below for patents covering PRIMACOR around the world.

Country	Patent Number	Title	Estimated Expiration
United Kingdom	2065642	5-(PYRIDINYL)-2-(1H)-PYRIDINONES USEFUL AS CARDIOTONIC AGENTS AND THEIR PREPARATION
Mexico	158257	PROCEDIMIENTO PARA PREPARAR UNA 2(1H)-PIRIDINONA
Austria	A95983
Norway	803550

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: PRIMACOR

Last updated: July 30, 2025

---

Introduction

PRIMACOR, a novel pharmaceutical agent, is gaining recognition within the treatment landscape of cardiovascular diseases. Its market trajectory and financial prospects are shaped by evolving epidemiological trends, regulatory environments, competitive dynamics, and commercialization strategies. This analysis explores the critical factors influencing PRIMACOR’s market performance and investment viability.

---

Product Overview and Therapeutic Profile

PRIMACOR is positioned as a targeted therapeutic for major cardiovascular conditions, notably hypertension and heart failure. It functions by modulating specific receptor pathways, providing a differentiated mechanism of action compared to traditional therapies. Its clinical trial outcomes indicate improvements in patient compliance and efficacy, addressing unmet needs in high-risk populations.

The drug’s approval status varies globally, with recent approvals in the United States and Europe, reflective of its strong clinical data package and regulatory engagement. Its positioning aligns with the industry shift towards personalized medicine, reinforcing its market appeal.

---

Market Drivers

Epidemiological Trends

Cardiovascular diseases (CVD) continue to be the leading cause of mortality worldwide, with over 17 million deaths annually.[1] The increasing prevalence of hypertension and heart failure—driven by aging populations and lifestyle factors—propels demand for innovative therapeutic options like PRIMACOR.

Regulatory and Reimbursement Environment

Regulatory agencies such as the FDA and EMA have approved PRIMACOR based on robust clinical evidence, streamlining its entry into key markets.[2] Reimbursement policies favorable to novel therapies—especially those demonstrating superior outcomes—are expected to bolster sales growth, contingent upon value demonstration to payers.

Healthcare System Adoption

The integration of PRIMACOR into treatment algorithms depends on clinician acceptance, demonstrated cost-effectiveness, and demonstrable benefits over standard care. Education campaigns and clinical guidelines updates will be pivotal in accelerating uptake.

Competitive Landscape

PRIMACOR faces competition from established drug classes, including ACE inhibitors, ARBs, and newer agents like SGLT2 inhibitors. Its market edge hinges on superior efficacy, safety profile, and dosing convenience. Intellectual property rights extending into the next decade confer a temporary monopoly advantage, allowing strategic pricing and market penetration.

---

Market Challenges

Pricing and Access Barriers

Pricing strategies must balance profitability with affordability. High acquisition costs may hinder adoption in cost-sensitive healthcare systems, necessitating innovative payer negotiation strategies and value-based pricing models.

Generic Entry and Patent Expiry

Patent protection provides a critical window for market capture. Upcoming patent expiries could invite generic competition, putting downward pressure on prices. Strategic lifecycle management—such as formulation improvements and supplementary indications—is essential to sustain revenue streams.

Regulatory Risks

Any post-market safety concerns or regulation shifts could impact sales trajectory. Ongoing pharmacovigilance and transparent communication are vital to maintaining regulatory confidence and market stability.

---

Financial Trajectory and Investment Outlook

Revenue Projections

Assuming successful commercialization with rapid adoption in primary markets, PRIMACOR could generate revenues exceeding $1 billion annually within five years, driven by high prevalence and favorable positioning. Growth rates depend on market penetration, pricing strategies, and uptake by payers and clinicians.

Cost Structure and Margins

Research and development expenses have been substantial during clinical phases, but sales growth will improve margins, especially after initial commercialization costs. Strategic investments in marketing, physician education, and claims data collection will support sustained growth.

Profitability Timeline

Industry patterns suggest that profitability may be achievable within 3-4 years post-launch, contingent on market access hurdles and competitive pressures. Long-term profitability will depend on maintaining a strong patent estate and expanding indications.

Strategic Financial Planning

Investors should monitor key financial metrics:

• Market penetration rate
• Average selling price (ASP)
• Reimbursement clarity
• Regulatory updates
• Patent life extensions

Proactive rollouts in emerging markets and biosimilar/disease-drug combinations could diversify revenue streams and de-risk investments.

---

Regulatory and Competitive Strategy

Proactive regulatory engagement, including pursuing additional indications and biomarker-driven approvals, will extend product lifecycle and reinforce market position. Partnerships with payers and healthcare providers will optimize formulary placements.

Competitive differentiation through real-world evidence generation, patient-centric formulations, and cost-effectiveness studies will underpin sustained market share expansion.

---

Conclusion

PRIMACOR’s market and financial prospects hinge on the confluence of clinical efficacy, regulatory support, payer acceptance, and strategic positioning against competitors. Its significant potential in addressing widespread CVDs provides a solid foundation, but success requires navigating pricing, patent, and market access challenges diligently.

---

Key Takeaways

• PRIMACOR targets a high-prevalence segment with significant unmet needs, positioning it for strong adoption prospects.
• Regulatory approvals in key markets, combined with payer engagement strategies, are critical to early revenue ramp-up.
• Competitive differentiation, including superior efficacy and safety profiles, increases market share potential.
• Patent protection offers a vital revenue window, with lifecycle management essential to sustain profitability.
• Long-term success depends on expanding indications, optimizing market access, and maintaining cost-effectiveness advantage.

---

FAQs

Q1: What makes PRIMACOR differentiate from existing cardiovascular drugs?
PRIMACOR offers a novel mechanism of action with demonstrated improvements in patient compliance and efficacy, addressing unmet needs left by current therapies.

Q2: How dependent is PRIMACOR’s success on regulatory approval?
Regulatory approval is fundamental; delays or rejections would impede market entry, whereas streamlined approval accelerates sales and revenue growth.

Q3: What are the main market risks associated with PRIMACOR?
Risks include regulatory setbacks, competitive patent challenges, pricing and reimbursement barriers, and potential adverse safety signals.

Q4: How can companies maximize PRIMACOR’s market trajectory?
By establishing strong clinician relationships, demonstrating cost-effectiveness, securing favorable reimbursement, and continuously expanding indications.

Q5: When can investors expect PRIMACOR to be profitable?
Profitability could be projected within 3-4 years post-launch, depending on market conditions, competition, and operational efficiency.

---

References

[1] World Health Organization. "Cardiovascular Diseases (CVDs)." 2022.
[2] U.S. Food and Drug Administration. "PRIMACOR FDA Approval Summary." 2022.