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Last Updated: March 18, 2024

AZITHROMYCIN Drug Patent Profile


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When do Azithromycin patents expire, and what generic alternatives are available?

Azithromycin is a drug marketed by Amneal, Aurobindo Pharma Ltd, Chartwell Rx, Epic Pharma Llc, Hainan Poly, Pliva, Sandoz, Taro, Teva Pharms, Zydus, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hospira, Mylan Asi, Rising, Slate Run Pharma, Sun Pharm Inds Ltd, Teva Parenteral, ACI, Alembic, Apotex Corp, Aurobindo Pharma Usa, Bionpharma, Cspc Ouyi, Lupin Ltd, Mylan, Sunshine, Teva, Yung Shin Pharm, and Zydus Pharms. and is included in sixty-three NDAs.

The generic ingredient in AZITHROMYCIN is azithromycin. There are thirty-two drug master file entries for this compound. Sixty-two suppliers are listed for this compound. Additional details are available on the azithromycin profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Azithromycin

A generic version of AZITHROMYCIN was approved as azithromycin by PLIVA on November 14th, 2005.

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Drug patent expirations by year for AZITHROMYCIN
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
Infectious Diseases Clinical Research ConsortiumPhase 4
Newcastle UniversityPhase 4
University College London HospitalsPhase 4

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Pharmacology for AZITHROMYCIN
Medical Subject Heading (MeSH) Categories for AZITHROMYCIN
Paragraph IV (Patent) Challenges for AZITHROMYCIN
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
AZASITE Ophthalmic Solution azithromycin 1% 050810 1 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
Zydus Pharms AZITHROMYCIN azithromycin TABLET;ORAL 213275-001 Apr 11, 2023 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Aurobindo Pharma Ltd AZITHROMYCIN azithromycin TABLET;ORAL 207398-001 Jul 5, 2018 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Aci AZITHROMYCIN azithromycin TABLET;ORAL 215772-001 Jul 15, 2022 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Cspc Ouyi AZITHROMYCIN azithromycin TABLET;ORAL 208250-001 Apr 17, 2019 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sandoz AZITHROMYCIN azithromycin TABLET;ORAL 065211-001 Nov 14, 2005 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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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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.