ZITHROMAX Drug Patent Profile

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Which patents cover Zithromax, and what generic alternatives are available?

Zithromax is a drug marketed by Pfizer and is included in seven NDAs.

The generic ingredient in ZITHROMAX is azithromycin. There are thirty-two drug master file entries for this compound. Sixty-four suppliers are listed for this compound. Additional details are available on the azithromycin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Zithromax

A generic version of ZITHROMAX was approved as azithromycin by PLIVA on November 14^th, 2005.

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Summary for ZITHROMAX

US Patents:	0
Applicants:	1
NDAs:	7
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	74
Clinical Trials:	104
Patent Applications:	1,679
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for ZITHROMAX
What excipients (inactive ingredients) are in ZITHROMAX?	ZITHROMAX excipients list
DailyMed Link:	ZITHROMAX at DailyMed

Drug patent expirations by year for ZITHROMAX

Recent Clinical Trials for ZITHROMAX

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

Sponsor	Phase
Bill and Melinda Gates Foundation	Phase 1
Brigham and Women's Hospital	Phase 1
School of Medicine and Health Sciences, University of Papua New Guinea	Phase 3

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Pharmacology for ZITHROMAX

Drug Class	Macrolide Antimicrobial

Anatomical Therapeutic Chemical (ATC) Classes for ZITHROMAX

J01FA	Macrolides
J01F	MACROLIDES, LINCOSAMIDES AND STREPTOGRAMINS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

S01AA	Antibiotics
S01A	ANTIINFECTIVES
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for ZITHROMAX

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	ZITHROMAX	azithromycin	CAPSULE;ORAL	050670-001	Nov 1, 1991		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Pfizer	ZITHROMAX	azithromycin	TABLET;ORAL	050784-001	May 24, 2002	AB	RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Pfizer	ZITHROMAX	azithromycin	FOR SUSPENSION;ORAL	050710-002	Oct 19, 1995	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for ZITHROMAX

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	ZITHROMAX	azithromycin	FOR SUSPENSION;ORAL	050693-001	Sep 28, 1994	⤷ Try a Trial	⤷ Try a Trial
Pfizer	ZITHROMAX	azithromycin	TABLET;ORAL	050730-001	Jun 12, 1996	⤷ Try a Trial	⤷ Try a Trial
Pfizer	ZITHROMAX	azithromycin	INJECTABLE;INJECTION	050733-001	Jan 30, 1997	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for ZITHROMAX

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

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	0298650	AZITHROMYCIN DIHYDRATE	⤷ Try a Trial
Yugoslavia	132588		⤷ Try a Trial
Canada	1314876	DIHYDRATE D'AZITHROMICINE (AZITHROMYCIN DIHYDRATE)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Summary for ZITHROMAX

Recent Clinical Trials for ZITHROMAX

Pharmacology for ZITHROMAX

Anatomical Therapeutic Chemical (ATC) Classes for ZITHROMAX

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