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 14th, 2005.
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 |



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 |
Pharmacology for ZITHROMAX
Drug Class | Macrolide Antimicrobial |
Anatomical Therapeutic Chemical (ATC) Classes for ZITHROMAX
US Patents and Regulatory Information for ZITHROMAX
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
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.
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 |