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Last Updated: March 1, 2024

AZASITE Drug Patent Profile


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

Azasite is a drug marketed by Thea Pharma 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-nine suppliers are listed for this compound. Additional details are available on the azithromycin profile page.

DrugPatentWatch® 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
Merck Sharp & Dohme Corp.Phase 2
Philadelphia Eye AssociatesPhase 2

See all AZASITE clinical trials

Pharmacology for AZASITE
Paragraph IV (Patent) Challenges for AZASITE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
AZASITE Ophthalmic Solution azithromycin 1% 050810 1 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
Thea Pharma AZASITE azithromycin SOLUTION/DROPS;OPHTHALMIC 050810-001 Apr 27, 2007 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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
Thea Pharma AZASITE azithromycin SOLUTION/DROPS;OPHTHALMIC 050810-001 Apr 27, 2007 ⤷  Try a Trial ⤷  Try a Trial
Thea Pharma AZASITE azithromycin SOLUTION/DROPS;OPHTHALMIC 050810-001 Apr 27, 2007 ⤷  Try a Trial ⤷  Try a Trial
Thea Pharma AZASITE azithromycin SOLUTION/DROPS;OPHTHALMIC 050810-001 Apr 27, 2007 ⤷  Try a Trial ⤷  Try a Trial
Thea Pharma AZASITE azithromycin SOLUTION/DROPS;OPHTHALMIC 050810-001 Apr 27, 2007 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for AZASITE

See the table below for patents covering AZASITE around the world.

Country Patent Number Title Estimated Expiration
Germany 69033199 ⤷  Try a Trial
Mexico PA01009718 TRATAMIENTO TOPICO O PREVENCION DE INFECCIONES OCULARES. (TOPICAL TREATMENT OR PREVENTION OF OCULAR INFECTIONS.) ⤷  Try a Trial
Denmark 168727 ⤷  Try a Trial
Canada 2086120 SUSPENSIONS OPHTALMIQUES A USAGE TOPIQUE (TOPICAL OPHTHALMIC SUSPENSIONS) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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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 verification 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.