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Serving leading biopharmaceutical companies globally:

Chubb
Daiichi Sankyo
Merck
Express Scripts
Boehringer Ingelheim
Cantor Fitzgerald
Farmers Insurance
Cerilliant
UBS
Mallinckrodt

Generated: October 23, 2017

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Azithromycin - Generic Drug Details

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What are the generic drug sources for azithromycin and what is the scope of azithromycin patent protection?

Azithromycin
is the generic ingredient in five branded drugs marketed by Hospira, Lupin Ltd, Gland Pharma Ltd, Wockhardt, Sagent Strides, Apotex Corp, Teva Parenteral, Sandoz, Pfizer, Oak Pharms Inc, Pliva, Teva Pharms, Sun Pharm Inds Ltd, Mylan Labs Ltd, Teva, Mylan, Pliva Hrvatska Doo, Fresenius Kabi Usa, Aurobindo Pharma Ltd, and Pf Prism Cv, and is included in forty-five NDAs. There are nine patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Azithromycin has two hundred and twenty patent family members in sixty-three countries.

There are thirty-two drug master file entries for azithromycin. Fifty-six suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for Generic Name: azithromycin

US Patents:9
Tradenames:5
Applicants:20
NDAs:45
Drug Master File Entries: see list32
Suppliers / Packagers: see list56
Bulk Api Vendors: see list41
Clinical Trials: see list306
Patent Applications: see list5,296
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:azithromycin at DailyMed

Pharmacology for Ingredient: azithromycin

Ingredient-typeMacrolides
Drug ClassMacrolide Antimicrobial

Tentative approvals for AZITHROMYCIN

Applicant Application No. Strength Dosage Form
u► Subscribe1%SOLUTION; OPHTHALMIC
u► Subscribe500MGINJECTABLE;INJECTION
u► Subscribe200MG/5MLSUSPENSION;ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva
AZITHROMYCIN
azithromycin
TABLET;ORAL065150-001Nov 14, 2005ABRXNoNo► Subscribe► Subscribe► Subscribe
Sandoz
AZITHROMYCIN
azithromycin
TABLET;ORAL065211-001Nov 14, 2005ABRXNoNo► Subscribe► Subscribe► Subscribe
Pliva
AZITHROMYCIN
azithromycin
TABLET;ORAL065218-001Nov 14, 2005ABRXNoNo► Subscribe► Subscribe► Subscribe
Sagent Strides
AZITHROMYCIN
azithromycin
INJECTABLE;INJECTION065506-001Mar 24, 2009APRXNoNo► Subscribe► Subscribe► Subscribe
Gland Pharma Ltd
AZITHROMYCIN
azithromycin
INJECTABLE;INJECTION065501-001Nov 9, 2009APRXNoNo► Subscribe► Subscribe► Subscribe
Teva
AZITHROMYCIN
azithromycin
TABLET;ORAL065153-001Nov 14, 2005ABRXNoNo► Subscribe► Subscribe► Subscribe
Sandoz
AZITHROMYCIN
azithromycin
FOR SUSPENSION;ORAL065297-001Sep 18, 2006DISCNNoNo► Subscribe► Subscribe► Subscribe
Pfizer
ZITHROMAX
azithromycin
INJECTABLE;INJECTION050733-001Jan 30, 1997APRXYesYes► Subscribe► SubscribeY ► Subscribe
Mylan
AZITHROMYCIN
azithromycin
TABLET;ORAL065366-001May 30, 2007DISCNNoNo► Subscribe► Subscribe► Subscribe
Hospira
AZITHROMYCIN
azithromycin
INJECTABLE;INJECTION065511-001Jun 26, 2009APRXNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: azithromycin

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Oak Pharms Inc
AZASITE
azithromycin
SOLUTION/DROPS;OPHTHALMIC050810-001Apr 27, 2007► Subscribe► Subscribe
Pf Prism Cv
ZMAX
azithromycin
FOR SUSPENSION, EXTENDED RELEASE;ORAL050797-001Jun 10, 2005► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: azithromycin

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
7,108,865Controlled-release dosage forms of azithromycin► Subscribe
7,732,415Topical treatment or prevention of ocular infections► Subscribe
6,699,492 Quinolone carboxylic acid compositions and related methods of treatment► Subscribe
7,749,970Topical treatment of prevention of ocular infections► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: azithromycin

Country Document Number Estimated Expiration
Ireland60210► Subscribe
Iceland4282► Subscribe
European Patent Office0758244► Subscribe
Denmark381188► Subscribe
Latvia10624► Subscribe
Germany60020351► Subscribe
Mexico12213► Subscribe
Spain2163504► Subscribe
Bulgaria63152► Subscribe
African Regional IP Organization (ARIPO)8800093► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

US Department of Justice
Cerilliant
Moodys
Teva
Farmers Insurance
Chubb
McKinsey
Cantor Fitzgerald
Queensland Health
Covington

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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