CORVERT Drug Patent Profile

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

Corvert is a drug marketed by Pfizer and is included in one NDA.

The generic ingredient in CORVERT is ibutilide fumarate. There are four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the ibutilide fumarate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Corvert

A generic version of CORVERT was approved as ibutilide fumarate by PHARMOBEDIENT on January 11^th, 2010.

Summary for CORVERT

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for CORVERT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	CORVERT	ibutilide fumarate	INJECTABLE;INJECTION	020491-001	Dec 28, 1995	AP	RX	Yes	Yes

International Patents for CORVERT

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

Country	Patent Number	Title	Estimated Expiration
Mexico	9203461	N-(AMINOALQUILFENIL)SULFONAMIDAS SU PREPARACION Y USO TERAPEUTICO.
Germany	3566886
Japan	S60239458	NOVEL COMPOUND AND ANTIARRHYTHMIC MEDICINE COMPOSITION
Hong Kong	16192	N-(AMINOALKYL-PHENYL)SULFONAMIDES THEIR PREPARATION AND THERAPEUTIC USE
Netherlands	970030
Japan	H0567620

Supplementary Protection Certificates for CORVERT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0164865	SPC/GB97/003	United Kingdom		PRODUCT NAME: IBUTILIDE, OR A PHARMACEUTICALLY-ACCEPTABLE SALT THEREOF, ESPECIALLY IBUTILIDE FUMARATE; REGISTERED: UK 00032/0212 19960930
0164865	97C0044	Belgium		PRODUCT NAME: IBUTILIDI FUMARAS (=IBUTILIDUM); NAT. REGISTRATION: 277 IS 253 F 12 19970617; FIRST REGISTRATION: GB PL 00032/0212 19960930
0164865	C970030	Netherlands		PRODUCT NAME: IBUTILIDE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARD BAAR ZOUT, IN HET BIJZONDER HET FUMARAAT; NAT. REGISTRATION NO/DATE: RVG 21286 19970612; FIRST REGISTRATION: GB PL 0032/0212 19960930

Investment Scenario and Fundamentals Analysis for Corvert (Amiodarone)

Last updated: February 12, 2026

What is Corvert and its Market Position?

Corvert (generic: amiodarone) is an antiarrhythmic medication indicated for the management of severe ventricular arrhythmias and atrial fibrillation. It is administered intravenously in acute care settings. Amiodarone's patent expired years ago, but Corvert remains a key brand in hospitals, especially where brand recognition influences prescribing habits.

Market Size and Growth Potential

The global antiarrhythmic drugs market was valued at approximately $2.4 billion in 2022, with a compound annual growth rate (CAGR) of around 4.2% projected through 2030. Amiodarone accounts for a significant share due to its high efficacy and established use.

Key Market Drivers:

• Increasing prevalence of atrial fibrillation, estimated at 37.6 million globally in 2020.
• Growing outpatient and inpatient management of cardiac arrhythmias.
• Expanding use in emergency and critical care settings.

Competitive Landscape:

• Other antiarrhythmic agents include lidocaine, sotalol, and dofetilide.
• Amiodarone’s long-standing clinical acceptance sustains its market position despite its adverse effect profile.

Patent and Regulatory Status

Amiodarone was first approved in 1961 (for oral) and later for intravenous use. The original patent has long expired, leading to widespread generic manufacturing. No recent regulatory exclusivity or patent protections remain, exposing Corvert to generic competition and affecting pricing strategies.

Regulatory Approvals:

• FDA approval for IV indication in 1983.
• Marketed as a prescription drug with strict usage protocols due to potential toxicity.

Financial and Commercial Fundamentals

Revenue Streams:

• Primarily from hospital settings in the form of branded (Corvert) and generic amiodarone.
• Limited outpatient sales due to administration restrictions and toxicity concerns.
• Pricing varies by region, generally lower for generics but still lucrative due to high-volume hospital use.

Cost of Goods Sold:

• Manufacturing costs are relatively low for generics, improving margins.
• Brand differentiation may involve costs related to labeling, patient safety communications, and regulatory compliance.

Pricing Trends:

• Average wholesale price for IV amiodarone ranges from $10 to $20 per vial (varies by country).
• Price pressure from generic entrants reduces brand premiums.

Patent and Market Risks:

• Absence of patent protection increases price competition.
• Market share depends on hospital formulary acceptance and clinical preference.
• Key to maintaining market share involves positioning Corvert as the preferred formulation in hospitals through medical education and safety programs.

Investment Risks and Opportunities

Risks:

• Price erosion driven by generics diminishes revenue.
• Utilization depends heavily on clinical guidelines and physician preferences.
• Toxicity profile (pulmonary, hepatic, cardiac adverse events) mandates rigorous safety management.
• Competition from newer antiarrhythmics and device-based therapies.

Opportunities:

• Expansion into emerging markets with rising cardiovascular disease burdens.
• Potential for formulation enhancements or combination therapies.
• Growing emphasis on rapid hospital-based drug administration can boost IV antiarrhythmic adoption.

Strategic Considerations

• Focus on hospital partnerships and formulary positioning.
• Investment in educational programs highlighting safety protocols.
• Monitoring regulatory changes influencing usage guidelines.
• Market expansion in regions with increasing cardiovascular disease prevalence.

Conclusions

Corvert remains a stable component within the antiarrhythmic market, driven by its long-established efficacy. While patent protections have expired, its entrenched hospital use sustains revenue but subjects it to intense price competition. Growth prospects hinge on expanding in emerging markets and leveraging clinical positioning.

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Key Takeaways

• Corvert (amiodarone) benefits from a large, aging population with increased arrhythmia incidences.
• Its market is limited by generic competition, with price pressure reducing margins.
• Hospital use dominates sales; outpatient prescriptions are minimal.
• No recent patent protections expose it to competition, but entrenched clinical practice sustains revenue.
• Opportunities exist in emerging markets and clinical positioning to offset pricing pressures.

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FAQs

1. How does Corvert compare to other antiarrhythmic drugs?
Corvert is favored for its efficacy in acute, severe arrhythmias but has a higher toxicity risk profile compared to drugs like sotalol or lidocaine, influencing its clinical use.

2. What are the primary regulatory concerns associated with Corvert?
Safety monitoring is critical due to risks of pulmonary fibrosis, thyroid dysfunction, and hepatic toxicity. Regulatory emphasis on risk mitigation impacts prescribing and administration practices.

3. Can Corvert's market grow significantly?
Growth potential exists in emerging markets with rising cardiovascular disease. However, mature markets face stagnation or decline due to generic competition.

4. How does pricing affect Corvert’s revenue?
Pricing pressure from generics reduces profitability, though high-volume hospital use maintains steady revenue streams.

5. What developments could impact Corvert’s future?
New antiarrhythmic approvals, changes in clinical guidelines favoring alternative therapies, or advances in device-based interventions could influence its market share.

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Citations

[1] MarketsandMarkets, “Antiarrhythmic Drugs Market,” 2023.
[2] World Health Organization, “Atrial Fibrillation Statistics,” 2020.
[3] FDA Drug Database, “Amiodarone Approval History,” 1983.