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Last Updated: August 6, 2020

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ZITHROMAX Drug 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. Fifty-seven suppliers are listed for this compound. Additional details are available on the azithromycin profile page.

US ANDA Litigation and Generic Entry Outlook for Zithromax

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

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Drug patent expirations by year for ZITHROMAX
Drug Prices for ZITHROMAX

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Drug Sales Revenue Trends for ZITHROMAX

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Recent Clinical Trials for ZITHROMAX

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

SponsorPhase
Ministry of Health, NigerPhase 4
Helen Keller InternationalPhase 4
Catholic Health InitiativesPhase 2

See all ZITHROMAX clinical trials

Pharmacology 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   Start Trial   Start Trial   Start Trial
Pfizer ZITHROMAX azithromycin TABLET;ORAL 050784-001 May 24, 2002 AB RX Yes No   Start Trial   Start Trial   Start Trial
Pfizer ZITHROMAX azithromycin FOR SUSPENSION;ORAL 050710-002 Oct 19, 1995 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Pfizer ZITHROMAX azithromycin TABLET;ORAL 050730-001 Jun 12, 1996 DISCN Yes No   Start Trial   Start Trial   Start 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 TABLET;ORAL 050784-001 May 24, 2002   Start Trial   Start Trial
Pfizer ZITHROMAX azithromycin FOR SUSPENSION;ORAL 050693-001 Sep 28, 1994   Start Trial   Start Trial
Pfizer ZITHROMAX azithromycin FOR SUSPENSION;ORAL 050710-002 Oct 19, 1995   Start Trial   Start Trial
Pfizer ZITHROMAX azithromycin TABLET;ORAL 050711-001 Jul 18, 1996   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Baxter
Express Scripts
Dow
Johnson and Johnson
Mallinckrodt
Moodys

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