CORVERT Drug Patent Profile

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

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. Three 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
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	67
Clinical Trials:	3
Patent Applications:	754
Drug Prices:	Drug price information for CORVERT
What excipients (inactive ingredients) are in CORVERT?	CORVERT excipients list
DailyMed Link:	CORVERT at DailyMed

See drug prices for CORVERT

Recent Clinical Trials for CORVERT

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

Sponsor	Phase
Cedars-Sinai Medical Center	Phase 4
National Heart, Lung, and Blood Institute (NHLBI)	Phase 4
Harvard University	Phase 4

See all CORVERT clinical trials

Pharmacology for CORVERT

Drug Class

Antiarrhythmic

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

Expired US Patents for CORVERT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	CORVERT	ibutilide fumarate	INJECTABLE;INJECTION	020491-001	Dec 28, 1995	5,155,268

International Patents for CORVERT

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

Country	Patent Number	Title	Estimated Expiration
Netherlands	970030
Mexico	9203461	N-(AMINOALQUILFENIL)SULFONAMIDAS SU PREPARACION Y USO TERAPEUTICO.
Japan	S60239458	NOVEL COMPOUND AND ANTIARRHYTHMIC MEDICINE COMPOSITION
Japan	H0567620
European Patent Office	0164865	N-(AMINOALKYLPHENYL)SULFONAMIDES THEIR PREPARATION AND THERAPEUTIC USE

Supplementary Protection Certificates for CORVERT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0164865	97C0044	Belgium		PRODUCT NAME: IBUTILIDI FUMARAS (=IBUTILIDUM); NAT. REGISTRATION: 277 IS 253 F 12 19970617; FIRST REGISTRATION: GB PL 00032/0212 19960930
0164865	SPC/GB97/003	United Kingdom		PRODUCT NAME: IBUTILIDE, OR A PHARMACEUTICALLY-ACCEPTABLE SALT THEREOF, ESPECIALLY IBUTILIDE FUMARATE; REGISTERED: UK 00032/0212 19960930

Last updated: July 31, 2025

rket Dynamics and Financial Trajectory for the Pharmaceutical Drug: CORVERT

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Introduction

CORVERT, the trade name for the drug Ciprofloxacin Hydrochloride, holds a notable position within the antimicrobial pharmaceutical market. Originally developed for bacterial infections, CORVERT's market dynamics are influenced by overlapping considerations of antimicrobial resistance, patent status, clinical utility, and evolving healthcare policies. This analysis explores the current market landscape, the financial trajectory of CORVERT, and key factors shaping its future prospects.

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Market Overview and Demand Drivers

CORVERT primarily functions as an antibiotic in the fluoroquinolone class, used to treat a broad spectrum of bacterial infections, including urinary tract infections (UTIs), respiratory infections, and skin infections. Its widespread adoption is driven by its efficacy, oral bioavailability, and broad-spectrum activity. However, recent shifts in market demand are driven by several key factors:

• Antimicrobial Resistance (AMR): The rising prevalence of AMR has led to decreased reliance on fluoroquinolones, including CORVERT. Many health authorities, such as the CDC and EMA, have issued warnings and restrictions on fluoroquinolone use due to adverse effects and resistance issues, impacting demand in developed markets.
• Emerging Alternatives: The rise of newer antibiotics with improved safety profiles and targeted activity threatens CORVERT’s market share. Bioequivalent formulations and novel classes, such as lipoglycopeptides and carbapenems, are compressing the traditional role of fluoroquinolones.
• Regulatory Environment: Regulatory agencies are tightening approval and marketing constraints for antibiotics associated with resistance and adverse effects, influencing the drug’s commercial prospects globally.

Market Segmentation and Global Reach

The global market for fluoroquinolone antibiotics, including CORVERT, was valued at approximately USD 2.5 billion in 2022 and is projected to experience moderate declines in developed countries, driven by restrictions and declining prescriptions. Conversely, markets in emerging economies, where antimicrobial stewardship is less stringent, could sustain demand, albeit at lower profit margins.

• North America & Europe: Marked by stringent regulatory controls and antimicrobial stewardship programs, these regions show declining prescriptions for fluoroquinolones, including CORVERT.
• Asia-Pacific & Latin America: These regions represent growing markets for antibiotics due to increased infection prevalence and less restrictive prescribing practices, offering potential for sustained or slightly growing demand.

Financial Trajectory and Revenue Outlook

Forecasting CORVERT’s financial trajectory involves examining revenue streams, pricing dynamics, competitive pressures, and lifecycle management strategies:

• Revenue Trends: Globally, revenues for CORVERT are experiencing regional divergence: sharp declines in North America and Europe due to regulation, tempered by stable or modestly growing sales in underserved markets. Estimated global revenue in 2022 stood at USD 1.2 billion, with projections indicating a compound annual decline rate (CAGR) of 3-5% over the next five years in mature markets.

• Pricing Dynamics: Price erosion is a significant factor. Generic competition, coupled with cost-cutting measures and regulatory mandates, has led to reduced per-unit pricing. Some markets witness price drops of up to 40% over five years.

• Patent and Exclusivity Considerations: CORVERT’s original patents expired in the late 2000s, leading to generic proliferation. This has intensified price competition, compressing margins and limiting revenue growth in mature markets.

• Lifecycle Management and Diversification: Bioequivalent generics dominate, but long-term growth prospects could emerge from new formulation variants, combination therapies, or niche indications—if regulatory pathways and clinical data support such moves.

Market Challenges and Opportunities

Challenges:

• Antimicrobial Stewardship: Increasingly restrictive guidelines curtail broad-spectrum antibiotic use, curbing market potential.
• Antimicrobial Resistance: Resistance development leads to reduced clinical efficacy, necessitating reformulation, dosing adjustments, or alternative therapies.
• Regulatory Restrictions: Agencies like the FDA and EMA continuously revise prescribing restrictions, impacting sales.
• Competitive Pressure: The generic industry’s intensified competition diminishes profit margins.

Opportunities:

• Emerging Markets: Increasing infections and weaker regulation create demand for generic fluoroquinolones like CORVERT.
• Strategic Partnerships: Collaborations with local distributors can improve market penetration in developing economies.
• New Indications: Off-label uses or expanding indications, supported by clinical research, may create new revenue streams.
• Formulation Innovation: Development of formulations with improved safety profiles (e.g., reduced adverse effects) can help reposition CORVERT within care pathways.

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Future Outlook and Strategic Considerations

The future financial trajectory of CORVERT hinges on navigating regulatory environments, antimicrobial resistance patterns, and competitive landscapes. Given the globalization of antibiotic markets, companies often leverage plantations in emerging markets, where demand remains resilient. However, in mature markets, revenue is likely to decline unless strategic repositioning occurs.

Key strategies for sustained viability include:

• Product Differentiation: Developing formulations with enhanced safety or efficacy profiles.
• Market Expansion: Focusing on underserved regions where infection rates are rising.
• Lifecycle Extension: Seeking regulatory approvals for new indications or formulations.
• Supply Chain Optimization: Controlling costs to maintain competitive pricing amid pricing pressures.

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Regulatory and Policy Impact on Future Financials

Regulatory agencies' policies significantly influence CORVERT’s financial prospects. Recent restrictions and warnings have decreased use in certain markets but have not entirely eliminated demand globally. Continued emphasis on antimicrobial stewardship is expected, aligning with global health priorities to reduce unnecessary antibiotic use, particularly in high-income countries.

However, the World Health Organization (WHO) classifies fluoroquinolones as critically important antimicrobials, adding a layer of global oversight that may further restrict use and affect revenue. Such policies suggest a long-term decline in mature markets, prompting firms to pivot toward diversification and innovation.

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Key Takeaways

• The global market for CORVERT is transitioning from growth to decline, driven by antimicrobial resistance, regulatory restrictions, and competition.
• Revenue erosion in developed regions contrasts with opportunities in emerging markets where demand persists due to less restrictive prescribing behaviors.
• The drug’s future financial trajectory requires strategic adaptations, including formulation improvements, market diversification, and partnership development.
• Regulatory landscapes continue to tighten, emphasizing stewardship and safety, likely constraining future growth unless accompanied by innovation.
• Active lifecycle management and geographic expansion are critical to maintaining the drug’s profitability and relevance in a dynamic antimicrobial landscape.

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FAQs

1. What are the main factors impacting CORVERT’s sales globally?
Antimicrobial resistance, regulatory restrictions, antimicrobial stewardship efforts, and competition from generics primarily influence CORVERT’s sales. In mature markets, these factors contribute to declining revenues, whereas demand remains relatively stable in emerging markets.

2. How has antimicrobial resistance affected CORVERT’s market share?
Rising resistance reduces the efficacy of fluoroquinolones, leading clinicians to limit their use, especially for uncomplicated infections. Consequently, this diminishes the drug's market share in regions prioritizing stewardship.

3. Are there ongoing efforts to reformulate or expand CORVERT’s indications?
While no widely announced reformulation programs exist currently, future possibilities depend on clinical evidence supporting new indications or improved formulations capable of addressing safety concerns and resistance issues.

4. What role do regulatory agencies play in shaping the drug’s future?
Agencies like the FDA, EMA, and WHO impose restrictions based on safety and resistance data, which influence prescribing practices and market access, directly impacting revenue trajectories for CORVERT.

5. What strategies can companies adopt to sustain profitability for older antibiotics like CORVERT?
Strategies include geographic expansion, formulation innovation, pursuing new indications, forming strategic partnerships, and optimizing manufacturing costs to offset declining demand in mature markets.

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References

1. U.S. Centers for Disease Control and Prevention (CDC). Antibiotic Resistance Threats in the United States, 2019.
2. European Medicines Agency (EMA). Antimicrobial Resistance and Antibiotic Use Report, 2022.
3. World Health Organization (WHO). Global Action Plan on Antimicrobial Resistance, 2015.
4. MarketWatch. Antibiotic Market Size & Share, 2022.
5. EvaluatePharma. 2022 Global Pharmaceutical Market Data.