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Last Updated: February 3, 2023

Azithromycin - Generic Drug Details


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

Azithromycin is the generic ingredient in five branded drugs marketed by Pfizer, Pf Prism Cv, Amneal, Aurobindo Pharma Ltd, Chartwell Rx, Epic Pharma Llc, Pliva, Sandoz, Taro, Teva Pharms, Zydus, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hainan Poly Pharm, Hikma, Hospira, Mylan Asi, Rising, Sun Pharm Inds Ltd, Teva Parenteral, Thea Pharma, ACI, Alembic Pharms Ltd, Apotex Corp, Bionpharma Inc, Cspc Ouyi, Lupin Ltd, Mylan, Sunshine, Teva, Wockhardt, and Yung Shin Pharm, and is included in seventy 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-eight 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

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Rambam Health Care CampusPhase 2
Second Affiliated Hospital, School of Medicine, Zhejiang UniversityPhase 4
Rajavithi HospitalN/A

See all azithromycin clinical trials

Generic filers with tentative approvals for AZITHROMYCIN
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing1%SOLUTION; OPHTHALMIC
See Plans and PricingSee Plans and PricingEQ 200MG BASE/5MLFOR SUSPENSION;ORAL
See Plans and PricingSee Plans and PricingEQ 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 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
Teva Pharms AZITHROMYCIN azithromycin FOR SUSPENSION;ORAL 065419-001 Jun 24, 2008 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Bionpharma Inc AZITHROMYCIN azithromycin TABLET;ORAL 210000-001 Feb 26, 2019 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Pfizer ZITHROMAX azithromycin FOR SUSPENSION;ORAL 050710-002 Oct 19, 1995 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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
Thea Pharma AZASITE azithromycin SOLUTION/DROPS;OPHTHALMIC 050810-001 Apr 27, 2007 See Plans and Pricing See Plans and Pricing
Pfizer ZITHROMAX azithromycin FOR SUSPENSION;ORAL 050693-001 Sep 28, 1994 See Plans and Pricing See Plans and Pricing
Pf Prism Cv ZMAX azithromycin FOR SUSPENSION, EXTENDED RELEASE;ORAL 050797-001 Jun 10, 2005 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent 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.