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Last Updated: June 28, 2022

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-three suppliers are listed for this compound. Additional details are available on the azithromycin profile page.

Drug patent expirations by year for AZASITE
Drug Prices for AZASITE

See drug prices for AZASITE

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Thea Pharma AZASITE azithromycin SOLUTION/DROPS;OPHTHALMIC 050810-001 Apr 27, 2007 See Plans and Pricing See Plans and Pricing
Thea Pharma AZASITE azithromycin SOLUTION/DROPS;OPHTHALMIC 050810-001 Apr 27, 2007 See Plans and Pricing See Plans and Pricing
Thea Pharma AZASITE azithromycin SOLUTION/DROPS;OPHTHALMIC 050810-001 Apr 27, 2007 See Plans and Pricing See Plans and Pricing
Thea Pharma AZASITE azithromycin SOLUTION/DROPS;OPHTHALMIC 050810-001 Apr 27, 2007 See Plans and Pricing See Plans and Pricing
>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
Japan 2510052 See Plans and Pricing
Denmark 0536255 See Plans and Pricing
Norway 894001 See Plans and Pricing
Hungary T68635 See Plans and Pricing
Japan H11240838 TREATMENT OF OPHTHALMIC INFECTION BY AZITHROMYCIN See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Baxter
Boehringer Ingelheim
Mallinckrodt
McKesson
McKinsey

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