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Last Updated: July 5, 2020

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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 freedom to operate?

Azithromycin is the generic ingredient in five branded drugs marketed by Pfizer, Pf Prism Cv, Amneal Pharms Llc, Aurobindo Pharma Ltd, Epic Pharma Llc, Lupin Ltd, Pliva, Sandoz, Taro, Teva Pharms, Zydus, Fresenius Kabi Usa, Gland Pharma Ltd, Hainan Poly Pharm, Hikma, Hospira, Mylan Asi, Mylan Labs Ltd, Sun Pharm Inds Ltd, Teva Parenteral, Oak Pharms Inc, Alembic Pharms Ltd, Apotex Corp, Bionpharma Inc, Cspc Ouyi, Mylan, Sunshine Lake, Teva, Wockhardt, and Yung Shin Pharm, and is included in sixty-six NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Azithromycin has fifty-one patent family members in forty-three countries.

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

Drug Prices for azithromycin

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Drug Sales Revenue Trends for azithromycin

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Recent Clinical Trials for azithromycin

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SponsorPhase
Wellcome TrustPhase 4
Department for International Development, United KingdomPhase 4
Helen Keller InternationalPhase 4

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Generic filers with tentative approvals for AZITHROMYCIN
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial1%SOLUTION; OPHTHALMIC
  Start Trial  Start TrialEQ 200MG BASE/5MLFOR SUSPENSION;ORAL
  Start Trial  Start TrialEQ 100MG BASE/5MLFOR SUSPENSION;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for azithromycin
Medical Subject Heading (MeSH) Categories for azithromycin
Paragraph IV (Patent) Challenges for AZITHROMYCIN
Tradename Dosage Ingredient NDA Submissiondate
AZASITE SOLUTION/DROPS;OPHTHALMIC azithromycin 050810 2011-03-03

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
Sandoz AZITHROMYCIN azithromycin FOR SUSPENSION;ORAL 065297-001 Sep 18, 2006 DISCN No No   Start Trial   Start Trial   Start Trial
Sandoz AZITHROMYCIN azithromycin TABLET;ORAL 065212-001 Nov 14, 2005 AB RX No No   Start Trial   Start Trial   Start Trial
Oak Pharms Inc AZASITE azithromycin SOLUTION/DROPS;OPHTHALMIC 050810-001 Apr 27, 2007 RX Yes Yes   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd AZITHROMYCIN azithromycin INJECTABLE;INJECTION 203294-001 Jun 19, 2015 AP RX No No   Start Trial   Start Trial   Start Trial
Pliva AZITHROMYCIN azithromycin TABLET;ORAL 065218-001 Nov 14, 2005 AB RX No Yes   Start Trial   Start Trial   Start Trial
Pfizer ZITHROMAX azithromycin FOR SUSPENSION;ORAL 050710-001 Oct 19, 1995 AB RX Yes No   Start Trial   Start Trial   Start Trial
Hospira AZITHROMYCIN azithromycin INJECTABLE;INJECTION 065511-001 Jun 26, 2009 AP RX No No   Start Trial   Start Trial   Start Trial
>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 azithromycin

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer ZITHROMAX azithromycin TABLET;ORAL 050784-001 May 24, 2002   Start Trial   Start Trial
Pfizer ZITHROMAX azithromycin FOR SUSPENSION;ORAL 050710-001 Oct 19, 1995   Start Trial   Start Trial
Pfizer ZITHROMAX azithromycin FOR SUSPENSION;ORAL 050693-001 Sep 28, 1994   Start Trial   Start Trial
Pf Prism Cv ZMAX azithromycin FOR SUSPENSION, EXTENDED RELEASE;ORAL 050797-001 Jun 10, 2005   Start Trial   Start Trial
Pfizer ZITHROMAX azithromycin FOR SUSPENSION;ORAL 050710-002 Oct 19, 1995   Start Trial   Start Trial
Oak Pharms Inc AZASITE azithromycin SOLUTION/DROPS;OPHTHALMIC 050810-001 Apr 27, 2007   Start Trial   Start Trial
Pfizer ZITHROMAX azithromycin TABLET;ORAL 050730-001 Jun 12, 1996   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Colorcon
Medtronic
McKesson
AstraZeneca
Harvard Business School

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 verification 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.