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Last Updated: August 4, 2020

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AZASITE Drug Profile

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Which patents cover Azasite, and when can generic versions of Azasite launch?

Azasite is a drug marketed by Oak Pharms Inc and is included in one NDA.

The generic ingredient in AZASITE 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 Azasite

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

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Drug patent expirations by year for AZASITE
Drug Prices for AZASITE

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Recent Clinical Trials for AZASITE

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

SponsorPhase
Thomas Jefferson UniversityPhase 2
Philadelphia Eye AssociatesPhase 2
Merck Sharp & Dohme Corp.Phase 2

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Pharmacology for AZASITE
Paragraph IV (Patent) Challenges for AZASITE
Tradename Dosage Ingredient NDA Submissiondate
AZASITE SOLUTION/DROPS;OPHTHALMIC azithromycin 050810 2011-03-03

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

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