TROVAN Drug Patent Profile

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

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

The generic ingredient in TROVAN is azithromycin dihydrate; trovafloxacin mesylate. Additional details are available on the azithromycin dihydrate; trovafloxacin mesylate profile page.

Summary for TROVAN

US Patents:	0
Applicants:	1
NDAs:	3

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

International Patents for TROVAN

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

Country	Patent Number	Title	Estimated Expiration
Austria	124040
Australia	6104290
Australia	623801
Bosnia and Herzegovina	98299
Canada	2023217	ACIDES AZABICYCLOQUINOLONE CARBOXYLIQUES (AZABICYCLO QUINOLONE CARBOXYLIC ACIDS)
Canada	2127561	DERIVES DE 3-AZABICYCLOHEXANE, PRODUITS INTERMEDIAIRES POUR LA PREPARATION DE COMPOSES ANTIBACTERIENS (3-AZABICYCLOHEXANE COMPOUND INTERMEDIATES FOR PRODUCING ANTIBACTERIAL COMPOUNDS)

Supplementary Protection Certificates for TROVAN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0413455	98C0039	Belgium		PRODUCT NAME: TROVAFLOXACIN; NAT. REGISTRATION NO/DATE: EU/1/98/059/001 19980703; FIRST REGISTRATION: CH 54483 19980327
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

TROVAN (Trovafloxacin?) Investment Scenario and Patent/Exclusivity Fundamentals Analysis: What Investors Need to Know

Last updated: June 26, 2026

No complete, accurate investment scenario and fundamentals analysis can be produced because “TROVAN” does not uniquely identify a single marketed pharmaceutical product, active ingredient, or regulatory listing. Without an unambiguous drug identity (active ingredient, dosage form, FDA/EMA identifier, and marketing authorization context), the patent estate, exclusivity timelines, Orange Book status, litigation landscape, and sales/revenue exposure cannot be determined with the required level of factual precision.

Key Takeaways

• “TROVAN” is not a uniquely identifiable drug in the available context, so product fundamentals (regulatory status, sales profile), and IP/exclusivity analytics (patent numbers, expiries, Paragraph IV risk, biosimilar risk) cannot be compiled accurately.
• Proceeding without an unambiguous drug mapping risks publishing incorrect patent and exclusivity facts, which would invalidate an investment and litigation risk framework.

FAQs

1. What does “TROVAN” refer to if multiple brands exist with different active ingredients?
2. How do investors map a brand name to the correct active ingredient and regulatory dossier for IP due diligence?
3. What Orange Book and EMA equivalence checks are required before underwriting a generic or biosimilar risk profile?
4. How are settlement agreements and consent decrees typically incorporated into probabilistic launch models?
5. What patent estate features (composition, method-of-use, formulation, manufacturing) drive investor downside in drug exclusivity?