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BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Argus Health
Dow
Chubb
Harvard Business School
US Army
UBS
Fish and Richardson
Medtronic
Queensland Health
Cantor Fitzgerald

Generated: December 18, 2017

DrugPatentWatch Database Preview

ZITHROMAX Drug Profile

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When do Zithromax patents expire, and what generic alternatives 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-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.
Drug patent expirations by year for ZITHROMAX

Pharmacology for ZITHROMAX

Ingredient-typeMacrolides
Drug ClassMacrolide Antimicrobial

Medical Subject Heading (MeSH) Categories for ZITHROMAX

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
PfizerZITHROMAXazithromycinCAPSULE;ORAL050670-001Nov 1, 1991DISCNYesNo► Subscribe► Subscribe► Subscribe
PfizerZITHROMAXazithromycinTABLET;ORAL050784-001May 24, 2002ABRXYesNo► Subscribe► SubscribeY► Subscribe
PfizerZITHROMAXazithromycinFOR SUSPENSION;ORAL050710-002Oct 19, 1995ABRXYesYes► Subscribe► SubscribeY► Subscribe
PfizerZITHROMAXazithromycinTABLET;ORAL050730-001Jun 12, 1996ABRXYesYes► Subscribe► SubscribeY► Subscribe
PfizerZITHROMAXazithromycinFOR SUSPENSION;ORAL050693-001Sep 28, 1994RXYesYes► Subscribe► SubscribeY► Subscribe
PfizerZITHROMAXazithromycinFOR SUSPENSION;ORAL050710-001Oct 19, 1995ABRXYesNo► Subscribe► SubscribeY► Subscribe
PfizerZITHROMAXazithromycinTABLET;ORAL050711-001Jul 18, 1996ABRXYesNo► Subscribe► SubscribeY► Subscribe
PfizerZITHROMAXazithromycinINJECTABLE;INJECTION050733-001Jan 30, 1997APRXYesYes► Subscribe► SubscribeY► Subscribe
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Paragraph IV (Patent) Challenges for ZITHROMAX

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

International Patent Family for Tradename: ZITHROMAX

Country Document Number Estimated Expiration
Argentina243532► Subscribe
Bosnia and Herzegovina98213► Subscribe
Spain2037833► Subscribe
Finland900087► Subscribe
Greece3003737► Subscribe
Denmark381188► Subscribe
Iceland1540► Subscribe
South Korea900006218► Subscribe
Ireland882107► Subscribe
African Intellectual Property Organization (OAPI)8743► 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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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Chinese Patent Office
Farmers Insurance
US Department of Justice
Accenture
Citi
Baxter
Merck
Medtronic
Cipla

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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