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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
AstraZeneca
Mallinckrodt
QuintilesIMS
Farmers Insurance
Daiichi Sankyo
Boehringer Ingelheim
Accenture
Covington
Harvard Business School

Generated: January 19, 2018

DrugPatentWatch Database Preview

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 Pfizer, Pf Prism Cv, Lupin Ltd, Pliva, Sandoz, Teva Pharms, Aurobindo Pharma Ltd, Cspc Ouyi Pharm Co, Fresenius Kabi Usa, Gland Pharma Ltd, Hospira, Mylan Labs Ltd, Sagent Strides, Sun Pharm Inds Ltd, Teva Parenteral, Oak Pharms Inc, Apotex Corp, Mylan, Teva, and Wockhardt, 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-eight suppliers are listed for this compound. There are three tentative approvals for this compound.
Pharmacology for azithromycin
Ingredient-typeMacrolides
Drug ClassMacrolide Antimicrobial
Medical Subject Heading (MeSH) Categories for azithromycin
Tentative approvals for AZITHROMYCIN
Applicant Application No. Strength Dosage Form
➤ Subscribe➤ Subscribe1%SOLUTION; OPHTHALMIC
➤ Subscribe➤ Subscribe500MGINJECTABLE;INJECTION
➤ Subscribe➤ Subscribe200MG/5MLSUSPENSION;ORAL

US Patents and Regulatory Information for azithromycin

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pfizer TROVAN/ZITHROMAX COMPLIANCE PAK azithromycin dihydrate; trovafloxacin mesylate FOR SUSPENSION, TABLET;ORAL 050762-001 Dec 18, 1998 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Hospira AZITHROMYCIN azithromycin INJECTABLE;INJECTION 065511-001 Jun 26, 2009 AP RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Apotex Corp AZITHROMYCIN azithromycin TABLET;ORAL 065509-001 Jul 13, 2011 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Teva Parenteral AZITHROMYCIN azithromycin INJECTABLE;INJECTION 050809-002 Dec 19, 2006 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Mylan AZITHROMYCIN azithromycin TABLET;ORAL 065360-001 Jan 8, 2007 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Teva Pharms AZITHROMYCIN azithromycin FOR SUSPENSION;ORAL 065419-002 Jun 24, 2008 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Pf Prism Cv ZMAX azithromycin FOR SUSPENSION, EXTENDED RELEASE;ORAL 050797-001 Jun 10, 2005 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sandoz AZITHROMYCIN azithromycin TABLET;ORAL 065212-001 Nov 14, 2005 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Pf Prism Cv ZMAX azithromycin FOR SUSPENSION, EXTENDED RELEASE;ORAL 050797-001 Jun 10, 2005 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Lupin Ltd AZITHROMYCIN azithromycin FOR SUSPENSION;ORAL 065488-001 May 15, 2015 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for azithromycin

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Oak Pharms Inc AZASITE azithromycin SOLUTION/DROPS;OPHTHALMIC 050810-001 Apr 27, 2007 ➤ Subscribe ➤ Subscribe
Pf Prism Cv ZMAX azithromycin FOR SUSPENSION, EXTENDED RELEASE;ORAL 050797-001 Jun 10, 2005 ➤ Subscribe ➤ Subscribe
Oak Pharms Inc AZASITE azithromycin SOLUTION/DROPS;OPHTHALMIC 050810-001 Apr 27, 2007 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for 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
7,749,970 Topical treatment of prevention of ocular infections ➤ Subscribe
7,108,865 Controlled-release dosage forms of azithromycin ➤ Subscribe
6,685,958 Quinolone carboxylic acid compositions and related methods of treatment ➤ Subscribe
7,732,415 Topical treatment or prevention of ocular infections ➤ Subscribe
6,699,492 Quinolone carboxylic acid compositions and related methods of treatment ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for azithromycin

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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Medtronic
Daiichi Sankyo
Citi
AstraZeneca
Johnson and Johnson
QuintilesIMS
Teva
Mallinckrodt

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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