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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Express Scripts
Federal Trade Commission
Colorcon
US Army
Teva
Boehringer Ingelheim
AstraZeneca
Argus Health
Accenture

Generated: January 23, 2018

DrugPatentWatch Database Preview

AZASITE Drug Profile

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

Azasite is a drug marketed by Oak Pharms Inc and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-three patent family members in nineteen countries.

The generic ingredient in AZASITE is azithromycin. There are thirty-two drug master file entries for this compound. Fifty-eight suppliers are listed for this compound. Additional details are available on the azithromycin profile page.
Summary for AZASITE
Drug patent expirations by year for AZASITE
Pharmacology for AZASITE
Ingredient-typeMacrolides
Drug ClassMacrolide Antimicrobial
Medical Subject Heading (MeSH) Categories for AZASITE

US Patents and Regulatory Information for AZASITE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Oak Pharms Inc AZASITE azithromycin SOLUTION/DROPS;OPHTHALMIC 050810-001 Apr 27, 2007 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Oak Pharms Inc AZASITE azithromycin SOLUTION/DROPS;OPHTHALMIC 050810-001 Apr 27, 2007 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Oak Pharms Inc AZASITE azithromycin SOLUTION/DROPS;OPHTHALMIC 050810-001 Apr 27, 2007 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Oak Pharms Inc AZASITE azithromycin SOLUTION/DROPS;OPHTHALMIC 050810-001 Apr 27, 2007 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Oak Pharms Inc AZASITE azithromycin SOLUTION/DROPS;OPHTHALMIC 050810-001 Apr 27, 2007 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for AZASITE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Oak Pharms Inc AZASITE azithromycin SOLUTION/DROPS;OPHTHALMIC 050810-001 Apr 27, 2007 ➤ Subscribe ➤ Subscribe
Oak Pharms Inc AZASITE azithromycin SOLUTION/DROPS;OPHTHALMIC 050810-001 Apr 27, 2007 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for AZASITE
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Ophthalmic Solution 1% ➤ Subscribe 3/3/2011

Non-Orange Book US Patents for AZASITE

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,685,958 Quinolone carboxylic acid compositions and related methods of treatment ➤ Subscribe
6,699,492 Quinolone carboxylic acid compositions and related methods of treatment ➤ Subscribe
7,732,415 Topical treatment or prevention of ocular infections ➤ Subscribe
7,749,970 Topical treatment of prevention of ocular infections ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for AZASITE

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Serving leading biopharmaceutical companies globally:

AstraZeneca
US Army
Accenture
Daiichi Sankyo
Farmers Insurance
Fuji
US Department of Justice
Teva
Johnson and Johnson

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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