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ZITHROMAX Drug Profile

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Which patents cover Zithromax, and what substitute generic drugs are available?

Zithromax is a drug marketed by Pfizer and is included in seven NDAs. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has sixty-eight patent family members in forty-two countries.

The generic ingredient in ZITHROMAX is azithromycin. There are thirty drug master file entries for this compound. Fifty-five suppliers are listed for this compound. There are three tentative approvals for this compound. Additional details are available on the azithromycin profile page.

Summary for Tradename: ZITHROMAX

Patents:1
Applicants:1
NDAs:7
Suppliers / Packagers: see list13
Bulk Api Vendors: see list33
Clinical Trials: see list18
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:ZITHROMAX at DailyMed

Pharmacology for Tradename: ZITHROMAX

Ingredient-typeMacrolides
Drug ClassMacrolide Antimicrobial
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pfizer
ZITHROMAX
azithromycin
FOR SUSPENSION;ORAL050710-001Oct 19, 1995RXYesNo6,268,489► SubscribeY ► Subscribe
Pfizer
ZITHROMAX
azithromycin
TABLET;ORAL050784-001May 24, 2002RXNoNo6,268,489► SubscribeY ► Subscribe
Pfizer
ZITHROMAX
azithromycin
TABLET;ORAL050730-001Jun 12, 1996RXYesYes6,268,489► SubscribeY ► Subscribe
Pfizer
ZITHROMAX
azithromycin
FOR SUSPENSION;ORAL050693-001Sep 28, 1994RXYesYes6,268,489► SubscribeY ► Subscribe
Pfizer
ZITHROMAX
azithromycin
FOR SUSPENSION;ORAL050710-002Oct 19, 1995RXYesYes6,268,489► SubscribeY ► Subscribe
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Paragraph IV activity for: ZITHROMAX

Drugname Dosage Strength RLD Submissiondate
azithromycinFor Injection500 mg/vialZithromax6/17/2011

International Patent Family for Tradename: ZITHROMAX

Country Document Number Estimated Expiration
Australia1883988► Subscribe
New Zealand225338► Subscribe
Morocco21323► Subscribe
Poland157145► Subscribe
Philippines30953► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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