TROVAN PRESERVATIVE FREE Drug Patent Profile

Which patents cover Trovan Preservative Free, and when can generic versions of Trovan Preservative Free launch?

Trovan Preservative Free is a drug marketed by Pfizer and is included in one NDA.

The generic ingredient in TROVAN PRESERVATIVE FREE is alatrofloxacin mesylate. Additional details are available on the alatrofloxacin mesylate profile page.

Summary for TROVAN PRESERVATIVE FREE

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	29
Patent Applications:	223
DailyMed Link:	TROVAN PRESERVATIVE FREE at DailyMed

US Patents and Regulatory Information for TROVAN PRESERVATIVE FREE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	TROVAN PRESERVATIVE FREE	alatrofloxacin mesylate	INJECTABLE;INJECTION	020760-001	Dec 18, 1997		DISCN	No	No
Pfizer	TROVAN PRESERVATIVE FREE	alatrofloxacin mesylate	INJECTABLE;INJECTION	020760-002	Dec 18, 1997		DISCN	No	No

Expired US Patents for TROVAN PRESERVATIVE FREE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	TROVAN PRESERVATIVE FREE	alatrofloxacin mesylate	INJECTABLE;INJECTION	020760-002	Dec 18, 1997	6,194,429
Pfizer	TROVAN PRESERVATIVE FREE	alatrofloxacin mesylate	INJECTABLE;INJECTION	020760-001	Dec 18, 1997	5,164,402
Pfizer	TROVAN PRESERVATIVE FREE	alatrofloxacin mesylate	INJECTABLE;INJECTION	020760-002	Dec 18, 1997	5,164,402
Pfizer	TROVAN PRESERVATIVE FREE	alatrofloxacin mesylate	INJECTABLE;INJECTION	020760-001	Dec 18, 1997	6,194,429

International Patents for TROVAN PRESERVATIVE FREE

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

Country	Patent Number	Title	Estimated Expiration
Ireland	902950
Czech Republic	9800552
Germany	69503066
Iceland	4351

Supplementary Protection Certificates for TROVAN PRESERVATIVE FREE

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	98C0040	Belgium		PRODUCT NAME: ALATROFLOXACIN; NAT. REGISTRATION NO/DATE: EU/1/98/060/001 19980327; FIRST REGISTRATION: CH 54484 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	98C0039	Belgium		PRODUCT NAME: TROVAFLOXACIN; NAT. REGISTRATION NO/DATE: EU/1/98/059/001 19980703; FIRST REGISTRATION: CH 54483 19980327

TROVAN PRESERVATIVE FREE Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory of Trovan (Trovafloxacin)

Introduction

Trovafloxacin, marketed under the brand name Trovan, is a broad-spectrum antibiotic that was once hailed for its efficacy against a wide range of bacterial infections. However, its market trajectory was drastically altered due to severe adverse reactions, leading to its eventual withdrawal from the market. Here, we delve into the market dynamics and financial implications of Trovan's rise and fall.

Market Entry and Initial Success

Approval and Launch

Trovafloxacin was approved by the U.S. Food and Drug Administration (FDA) in December 1997 for use in patients aged 18 years and older. It was also approved in the European Union in October 1998. Initially, the drug showed promise with better Gram-positive bacterial coverage compared to other fluoroquinolones, although it had less Gram-negative coverage[3].

Revenue Contribution

During its first full year on the market, Trovan contributed significantly to Pfizer's revenue, generating $160 million out of the company's total revenue of $12.6 billion. Investors had high expectations, predicting that the drug could eventually bring in $1 billion per year[3].

Adverse Reactions and Regulatory Actions

Hepatotoxicity Concerns

The drug's market success was short-lived due to reports of severe hepatotoxicity. By June 1999, the FDA advised doctors to limit prescriptions of Trovan due to over 100 cases of acute liver injury. This led to a significant decline in its use and eventual regulatory actions against it[3].

Market Withdrawal

In May 2000, the FDA withdrew the marketing authorization for Trovan. Similarly, in the European Union, the marketing authorization was suspended in August 1999 and later voluntarily withdrawn by Pfizer in October 2000[3].

Financial Impact

Revenue Loss

The withdrawal of Trovan from the market resulted in a substantial loss of potential revenue for Pfizer. The drug had been projected to be a major contributor to the company's income, but its removal meant that these expectations were never realized[3].

Legal and Public Relations Costs

The controversy surrounding Trovan, particularly the illegal clinical trial in Nigeria, added significant legal and public relations costs for Pfizer. The company faced public outcry, legal investigations, and potential lawsuits, all of which impacted its financial health and reputation[3].

Market Dynamics and Competition

Impact on Market Concentration

The withdrawal of Trovan did not significantly alter the overall market concentration in the pharmaceutical industry, as other drugs filled the gap. However, it highlighted the importance of rigorous clinical trials and regulatory oversight to ensure drug safety[3].

Consumer Welfare

The rise and fall of Trovan underscore the importance of consumer welfare in market dynamics. The drug's adverse reactions led to a reduction in consumer welfare, as patients were exposed to unnecessary health risks. This incident reinforced the need for stringent regulatory standards to protect public health[5].

Lessons Learned

Importance of Safety Trials

The Trovan case emphasizes the critical role of thorough safety trials before a drug is approved for market use. The failure to identify severe side effects during the initial trials led to devastating consequences for patients and significant financial losses for Pfizer[3].

Regulatory Vigilance

The incident highlights the importance of regulatory bodies in ensuring drug safety. The FDA's swift action in limiting and eventually withdrawing Trovan from the market saved countless lives and underscored the necessity of vigilant regulatory oversight[3].

Key Takeaways

• Market Entry and Success: Trovan initially showed promise and contributed significantly to Pfizer's revenue.
• Adverse Reactions: Severe hepatotoxicity led to regulatory actions and market withdrawal.
• Financial Impact: Substantial revenue loss and additional legal and public relations costs.
• Market Dynamics: Did not significantly alter market concentration but highlighted the importance of safety trials and regulatory oversight.
• Consumer Welfare: Reduced consumer welfare due to health risks, emphasizing the need for stringent regulatory standards.

FAQs

What was the primary reason for the withdrawal of Trovan from the market?

The primary reason for the withdrawal of Trovan was the risk of severe hepatotoxicity, leading to acute liver injury and death in some cases[3].

How did the FDA respond to the adverse reactions associated with Trovan?

The FDA advised doctors to limit prescriptions of Trovan in June 1999 and later withdrew the marketing authorization in May 2000[3].

What were the financial implications of Trovan's withdrawal for Pfizer?

The withdrawal resulted in a significant loss of potential revenue and added legal and public relations costs due to the controversy surrounding the drug[3].

What lessons can be learned from the Trovan case?

The importance of thorough safety trials and vigilant regulatory oversight to protect public health and ensure consumer welfare[3].

How did the Trovan incident impact the pharmaceutical industry's approach to drug safety?

The incident reinforced the need for rigorous clinical trials and stringent regulatory standards to ensure drug safety, impacting the industry's approach to drug development and approval processes[3].

Sources

1. ECB Working Paper Series No 2253 - Concentration, market power and dynamism in the euro area[1].
2. Theravance Biopharma Press Release - Results from Study 0170[2].
3. Wikipedia - Trovafloxacin[3].
4. Krause Fund Research - Pfizer (PFE) Investment Thesis[4].
5. NBER Working Paper - The Rise of Market Power and the Macroeconomic Implications[5].