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Azithromycin - Generic Drug Details

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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, Teva, Mylan, Pliva Hrvatska Doo, Fresenius Kabi Usa, Aurobindo Pharma Ltd, and Pf Prism Cv, and is included in forty-four NDAs. There are nine patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has two hundred and eight patent family members in sixty-three countries.

There are twenty-nine drug master file entries for azithromycin. Fifty-three suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for Generic Name: azithromycin

Tradenames:5
Patents:9
Applicants:19
NDAs:44
Drug Master File Entries: see list29
Suppliers / Packaging: see list53
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: azithromycin

Ingredient-typeMacrolides
Drug ClassMacrolide Antimicrobial

Tentative approvals for AZITHROMYCIN

Applicant Application No. Form Dosage
<disabled><disabled>SOLUTION; OPHTHALMIC1%
<disabled><disabled>SUSPENSION;ORAL300MG(100MG/5ML)
<disabled><disabled>SUSPENSION;ORAL1200MG(200MG/5ML)
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pf Prism Cv
ZMAX
azithromycin
FOR SUSPENSION, EXTENDED RELEASE;ORAL050797-001Jun 10, 2005RXYes6,068,859► subscribeY ► subscribe
Sandoz
AZITHROMYCIN
azithromycin
FOR SUSPENSION;ORAL065297-001Sep 18, 2006DISCNNo► subscribe► subscribe
Pf Prism Cv
ZMAX
azithromycin
FOR SUSPENSION, EXTENDED RELEASE;ORAL050797-001Jun 10, 2005RXYes6,268,489► subscribeY ► 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, 20075,192,535► 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
7,749,970Topical treatment of prevention of ocular infections► subscribe
6,685,958 Quinolone carboxylic acid compositions and related methods of treatment► subscribe
6,699,492 Quinolone carboxylic acid compositions and related methods of treatment► 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
European Patent Office1395215► subscribe
Austria296093► subscribe
Egypt18527► 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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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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