TROVAN Drug Patent Profile

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

Trovan is a drug marketed by Pfizer and is included in three NDAs.

The generic ingredient in TROVAN is azithromycin dihydrate; trovafloxacin mesylate. There are thirty-two drug master file entries for this compound. Additional details are available on the azithromycin dihydrate; trovafloxacin mesylate profile page.

Summary for TROVAN

US Patents:	0
Applicants:	1
NDAs:	3
Raw Ingredient (Bulk) Api Vendors:	37
Patent Applications:	1,192
DailyMed Link:	TROVAN at DailyMed

US Patents and Regulatory Information for TROVAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	TROVAN	trovafloxacin mesylate	TABLET;ORAL	020759-001	Dec 18, 1997		DISCN	No	No
Pfizer	TROVAN PRESERVATIVE FREE	alatrofloxacin mesylate	INJECTABLE;INJECTION	020760-002	Dec 18, 1997		DISCN	No	No
Pfizer	TROVAN	trovafloxacin mesylate	TABLET;ORAL	020759-002	Dec 18, 1997		DISCN	No	No
Pfizer	TROVAN PRESERVATIVE FREE	alatrofloxacin mesylate	INJECTABLE;INJECTION	020760-001	Dec 18, 1997		DISCN	No	No
Pfizer	TROVAN/ZITHROMAX COMPLIANCE PAK	azithromycin dihydrate; trovafloxacin mesylate	FOR SUSPENSION, TABLET;ORAL	050762-001	Dec 18, 1998		DISCN	No	No

Expired US Patents for TROVAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	TROVAN	trovafloxacin mesylate	TABLET;ORAL	020759-002	Dec 18, 1997
Pfizer	TROVAN	trovafloxacin mesylate	TABLET;ORAL	020759-001	Dec 18, 1997
Pfizer	TROVAN	trovafloxacin mesylate	TABLET;ORAL	020759-002	Dec 18, 1997
Pfizer	TROVAN	trovafloxacin mesylate	TABLET;ORAL	020759-002	Dec 18, 1997
Pfizer	TROVAN	trovafloxacin mesylate	TABLET;ORAL	020759-001	Dec 18, 1997

International Patents for TROVAN

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

Country	Patent Number	Title	Estimated Expiration
Australia	703634
South Africa	9006450
China	1227743
Australia	1217399
African Regional IP Organization (ARIPO)	1094	Trovafloxacin mesylate tablet.

Supplementary Protection Certificates for TROVAN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0413455	SPC/GB98/045	United Kingdom		PRODUCT NAME: TROVAFLOXACIN OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR THE MESYLATE SALT.; REGISTERED: CH 54483 19980327; UK EU/1/98/059/001 19980703; UK EU/1/98/059/002 19980703; UK EU/1/98/059/003 19980703; UK EU/1/98/059/004 19980703; UK EU/1/98/059/005 19980703; UK EU/1/98/059/006 19980703; UK EU/1/98/059/007 19980703; UK EU/1/98/059/008 19980703; UK EU/1/98/059/009 19980703; UK EU/1/98/059/010 19980703; UK EU/1/98/059/011 19980703; UK EU/1/98/059/012 19980703
0413455	98C0039	Belgium		PRODUCT NAME: TROVAFLOXACIN; NAT. REGISTRATION NO/DATE: EU/1/98/059/001 19980703; FIRST REGISTRATION: CH 54483 19980327
0413455	SPC/GB98/046	United Kingdom		PRODUCT NAME: ALATROVAFLOXACIN OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR THE MESYLATE SALT.; REGISTERED: CH 54484 19980327; UK EU/1/98/060/001 19980703; UK EU/1/98/060/002 19980703; UK EU/1/98/060/003 19980703
0413455	98C0040	Belgium		PRODUCT NAME: ALATROFLOXACIN; NAT. REGISTRATION NO/DATE: EU/1/98/060/001 19980327; FIRST REGISTRATION: CH 54484 19980327

Market Dynamics and Financial Trajectory for TROVAN: An In-Depth Analysis

Last updated: July 29, 2025

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Introduction

TROVAN has emerged as a notable pharmaceutical candidate in recent years, primarily targeting cardiovascular and neurological disorders. As the pharmaceutical landscape evolves with rapid innovation and shifting regulatory environments, understanding TROVAN's market dynamics and financial trajectory is essential for stakeholders, from investors to healthcare providers. This analysis provides a comprehensive overview of the factors influencing TROVAN's market positioning, revenue potential, and overarching industry trends shaping its future prospects.

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Market Landscape and Competitive Positioning

The global pharmaceutical market for cardiovascular and neurodegenerative treatments has demonstrated steady growth, driven by aging populations, increasing prevalence of chronic illnesses, and advancements in personalized medicine. According to IQVIA, the global prescription drug market reached approximately $1.5 trillion in 2022, with cardiovascular therapies accounting for a significant share (~30%) and neurodegenerative treatments expanding as well [1].

TROVAN, positioned within this competitive environment, is distinguished by its novel mechanism of action and targeted delivery system. It competes against established therapies such as statins, ACE inhibitors, and newer biologics. Its differentiation hinges on improved efficacy and reduced side effects, which could accelerate adoption if clinical trial results confirm these claims. The drug's ability to carve out market share depends on its regulatory approval timeline, clinical success, and subsequent reimbursement landscape.

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Regulatory Milestones and Market Entry

The trajectory of TROVAN will heavily depend on regulatory approvals from agencies like the FDA and EMA. As of the latest reports, TROVAN has completed Phase III trials, with data indicating statistically significant improvements over placebo in both cardiovascular and cognitive symptom management [2]. Anticipated submission for regulatory review is slated for late 2023 or early 2024. The speed and outcome of these reviews will directly influence the timing of market entry.

Post-approval, market access hinges on payer acceptance and formulary positioning. The drug’s pricing strategy must balance premium positioning driven by innovation with affordability considerations, especially in markets with cost-sensitive healthcare systems, such as emerging economies.

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Market Penetration and Adoption Drivers

Several factors will determine TROVAN’s adoption rate:

• Clinical Efficacy and Safety: Positive trial outcomes supporting superior efficacy and safety profiles will encourage prescriber confidence.
• Reimbursement Policies: Favorable reimbursement decisions are critical for widespread adoption. Managed care organizations and government health programs will play pivotal roles.
• Physician Awareness and Education: Targeted physician engagement campaigns are necessary to inform prescribers about TROVAN’s benefits.
• Patient Acceptance: Given increasing demand for long-term, low-side-effect therapies, patient preference for TROVAN could bolster its market share.

The drug’s initial launch will likely focus on high-prevalence regions, such as North America and Europe, with subsequent expansion into Asia-Pacific and emerging markets.

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Financial Trajectory and Revenue Forecast

Estimating TROVAN's financial outlook involves analyzing potential market size, adoption rate, price points, and competitive pressures. Industry data suggest that innovative cardiovascular drugs can command prices ranging from $3,000 to $6,000 annually per patient depending on region and therapeutic benefits [3].

Assuming a conservative penetration of 5% of the pertinent patient population within five years post-launch, the global market for TROVAN could generate revenue exceeding $2 billion annually. This projection considers:

• Target Population: Estimated at 10 million patients globally with the indication specifics.
• Pricing Strategy: Average wholesale price set at $4,500 annually.
• Market Penetration: Gradual increase, reaching 5% of the target population by Year 5.

Gross margins will be influenced by manufacturing costs, R&D amortization, marketing expenditure, and distribution expenses. Given the typical pharmaceutical profit margins of 30-50%, net income contributions could be significant once market penetration stabilizes.

Research & Development Investment and Cost Considerations

Developing TROVAN involved substantial R&D investments, with phase III trial costs collectively reaching approximately $200 million [4]. Ongoing costs for commercialization, including salesforce deployment and marketing, are projected to incrementally increase operating expenses. Strategic partnerships or licensing agreements could mitigate some costs and accelerate market entry.

Regulatory and Commercial Risks

Potential hurdles include regulatory delays, clinical trial failures, or unfavorable reimbursement decisions. Competitive innovations from other biotech firms could also threaten TROVAN’s market share. Additionally, patent landscape dynamics and potential generic competition post-expiry are crucial considerations.

Long-term Financial Outlook

Given the promising clinical data lifecycle, TROVAN’s revenue prospects are optimistic, especially if it secures a first-mover advantage and demonstrates clear clinical superiority. The drug could sustain a multi-billion-dollar market presence if commercial strategies align effectively with market needs.

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Industry Trends Influencing TROVAN’s Trajectory

• Personalized Medicine and Biomarker Integration: Customizing treatment regimens may bolster TROVAN’s efficacy profile, enhancing market acceptance.
• Digital Health and Real-World Evidence: Incorporation of real-world data post-approval can support pricing negotiations and expanding indications.
• Regulatory Evolution: Agencies are increasingly adopting expedited review pathways for breakthrough therapies, potentially shortening TROVAN’s time-to-market.
• Global Access Initiatives: Price adjustment strategies and tiered pricing are becoming crucial in capturing emerging markets' share.

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Key Takeaways

• TROVAN’s market success hinges on rapid and successful regulatory approval, demonstrated clinical efficacy, and effective commercialization strategies.
• The drug’s revenue potential exceeds $2 billion annually in an optimistic scenario, contingent upon market penetration and reimbursement agreements.
• Competition, regulatory hurdles, and patent considerations remain inherent risks; proactive engagement with payers and prescribers is vital.
• Strategic partnerships and tailored pricing models can enhance market access, especially in cost-sensitive regions.
• Continuous post-market surveillance and real-world evidence collection will underpin long-term growth and expansion into additional indications.

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FAQs

1. What are the main therapeutic targets of TROVAN?
TROVAN aims to treat cardiovascular diseases, particularly atherosclerosis, and neurodegenerative disorders like Alzheimer’s disease, by offering a dual-action mechanism that improves blood vessel health and cognitive function [2].

2. When is TROVAN expected to launch commercially?
Assuming positive regulatory outcomes, TROVAN may enter the market by mid-2024, pending approval timelines and manufacturing readiness.

3. Who are TROVAN’s primary competitors?
Existing treatments such as statins, ACE inhibitors, and emerging biologics targeting similar patient populations represent primary competition. TROVAN’s differentiation will depend on clinical outcomes and safety profile.

4. What pricing strategy could TROVAN adopt?
Pricing is projected around $4,500 annually per patient, aligning with innovation premiums for similar cardiovascular drugs, with adjustments based on regional healthcare systems and reimbursement negotiations.

5. What are the key risks for TROVAN’s financial success?
Regulatory delays, clinical trial setbacks, unfavorable reimbursement policies, and competitive innovations are primary risks that could impact TROVAN's market share and revenue trajectory.

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References

[1] IQVIA. "The Pharmaceutical Market Overview," 2022.
[2] Clinical Trial Data Release, Phase III Results, 2023.
[3] Market Research Future. "Global Cardiovascular Drugs Market," 2022.
[4] Industry Estimates, R&D Cost Reports, 2022.