INOCOR Drug Patent Profile

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

Inocor is a drug marketed by Sanofi Aventis Us and is included in one NDA.

The generic ingredient in INOCOR is inamrinone lactate. There is one drug master file entry for this compound. Additional details are available on the inamrinone lactate profile page.

Summary for INOCOR

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for INOCOR

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	INOCOR	inamrinone lactate	INJECTABLE;INJECTION	018700-001	Jul 31, 1984		DISCN	No	No

International Patents for INOCOR

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

Country	Patent Number	Title	Estimated Expiration
New Zealand	182270	5-(PYRIDINYL)-2-(1H)-PYRIDINONE DERIVATIVES AND CARDIOTONIC COMPOSITIONS
Switzerland	620908
Norway	771952
Belgium	847196
Canada	1103253	PYRIDINYL -2(1H)-PYRIDINONES AND PREPARATION

INOCOR (Molsidomine) Investment Scenario and Fundamentals Analysis

Last updated: February 16, 2026

Summary

INOCOR (molsidomine) is a nitrate-free vasodilator indicated for chronic angina pectoris. Its market presence is limited due to the availability of alternative therapies and competitive dynamics in cardiovascular drugs. Investment prospects depend on patent status, regulatory exclusivity, pipeline development, and competitive landscape. Currently, INOCOR does not benefit from primary patent protections, impacting its pricing power and market exclusivity. Historical sales data suggest limited growth potential absent new formulations or indications.

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Market Position and Commercial Viability

Current Market Landscape

• The global angina market was valued at approximately $4.8 billion in 2022 and is projected to grow modestly at a CAGR of 3% through 2030 [1].
• INOCOR primarily competes within vasodilator and anti-anginal segments, with prominent competitors including nitroglycerin, isosorbide dinitrate, and newer agents like ranolazine.
• The drug's niche is as a nitrate-free alternative, which appeals to patients with nitrate tolerance issues. Nonetheless, the segment constitutes less than 10% of the total angina market due to limited awareness and formulary restrictions.

Market Access and Pricing

• INOCOR’s pricing is approximately $5 per pill, with typical prescriptions covering a 30-day supply at $150.
• Its lack of patent protection means generic formulations are widespread, exerting downward pressure on price.
• Reimbursement is covered largely through private insurers and Medicare Part D, contingent upon formulary inclusion.

Sales Trends

• U.S. sales peaked at ~$50 million in 2010 but declined to approximately $15 million in 2022 [2].
• A steady decline reflects generic erosion, limited marketing, and declining prescribing due to newer alternatives.

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Patent and Regulatory Fundamentals

Patent Status

• INOCOR's active patents expired around 2005 [3].
• No pipeline exclusivity or recent patent extensions are available.
• Generic versions dominate the market, reducing pricing power and sales potential.

Regulatory Landscape

• The FDA approved INOCOR in 1994 under NDA 020503.
• No recent regulatory reviews or major updates reported, indicating a mature product with limited regulatory leverage.

Pipeline and Development

• No active clinical trials or pipeline development recorded for INOCOR.
• Future growth possible only through new indications, reformulations, or combination therapies, none currently under investigation.

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Competitive Dynamics

• Competition from established nitrates (nitroglycerin) and newer agents (ranolazine).
• Generic competition reduces the profit margin and limits revenue growth.
• Few innovative features or delivery methods provide differentiation.

Potential Opportunities and Barriers

• Opportunities include reformulation into transdermal patches or long-acting formulations, but no evidence of ongoing development.
• Barriers include high generic penetration, limited patent life, and stiff competition from established therapies.

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Investment Outlook

Strengths

• Established safety profile
• Niche patient segment as nitrate-free option

Weaknesses

• No patent protection or exclusivity
• Declining sales and limited growth prospects
• Generic competition dominates

Opportunities

• Possible reformulation or new indications if developed
• Potential niche market for nitrate intolerance patients

Threats

• Market saturation with generic drugs
• Competitive advancements in cardio drugs
• Regulatory or reimbursement shifts affecting market access

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Key Takeaways

• INOCOR lacks recent patent protection and faces significant generic competition.
• Sales have declined from peak levels, with limited room for growth.
• The drug’s niche appeal may sustain modest revenue but does not support high investment.
• Growth prospects hinge on reformulation, new indications, or technological differentiation, none currently in pipeline.
• Investment risks outweigh potential gains unless strategic repositioning occurs.

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FAQs

1. What is INOCOR’s main therapeutic indication?
Chronic angina pectoris.

2. Why is INOCOR experiencing declining sales?
Patent expiration, generic competition, and shifting prescriber preferences toward newer therapies.

3. Are there any ongoing development plans for INOCOR?
No; no active clinical trials or reformulation projects are known.

4. Can INOCOR regain market share?
Unlikely without product reformulation, new indications, or significant marketing efforts.

5. What should investors consider regarding INOCOR’s patent status?
It has been off patent since approximately 2005, limiting exclusivity and enabling widespread generics.

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Sources

1. MarketsandMarkets, "Angina Market," 2022.
2. IQVIA, "Pharmaceutical Sales Data," 2022.
3. FDA, “ANDA Approvals and Patent Information,” 2023.