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. Sixty-eight 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 14^th, 2005.

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Summary for AZASITE

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	74
Clinical Trials:	17
Patent Applications:	3,137
Drug Prices:	Drug price information for AZASITE
What excipients (inactive ingredients) are in AZASITE?	AZASITE excipients list
DailyMed Link:	AZASITE at DailyMed

Drug patent expirations by year for AZASITE

Recent Clinical Trials for AZASITE

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

Sponsor	Phase
Thomas Jefferson University	Phase 2
Merck Sharp & Dohme Corp.	Phase 2
Philadelphia Eye Associates	Phase 2

See all AZASITE clinical trials

Pharmacology for AZASITE

Drug Class	Macrolide Antimicrobial

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

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Glossary

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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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Thea Pharma	AZASITE	azithromycin	SOLUTION/DROPS;OPHTHALMIC	050810-001	Apr 27, 2007	⤷ Sign Up	⤷ Sign Up
Thea Pharma	AZASITE	azithromycin	SOLUTION/DROPS;OPHTHALMIC	050810-001	Apr 27, 2007	⤷ Sign Up	⤷ Sign Up
Thea Pharma	AZASITE	azithromycin	SOLUTION/DROPS;OPHTHALMIC	050810-001	Apr 27, 2007	⤷ Sign Up	⤷ Sign Up
>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.

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Country	Patent Number	Title	Estimated Expiration
New Zealand	503063	Sustained release ophthalmic compositions containing water soluble medicaments	⤷ Sign Up
Japan	2002540147		⤷ Sign Up
Australia	8103991		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration