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Last Updated: March 19, 2024

AZITHROMYCIN - Generic Drug Details


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What are the generic 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, 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, Thea Pharma, 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 seventy-three 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. Sixty-two 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
Infectious Diseases Clinical Research ConsortiumPhase 4
Royal Brompton & Harefield NHS Foundation TrustPhase 4
Dr Ian B WilkinsonPhase 4

See all AZITHROMYCIN clinical trials

Generic filers with tentative approvals for AZITHROMYCIN
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial1%SOLUTION; OPHTHALMIC
⤷  Try a Trial⤷  Try a TrialEQ 200MG BASE/5MLFOR SUSPENSION;ORAL
⤷  Try a Trial⤷  Try a 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 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
Lupin Ltd AZITHROMYCIN azithromycin TABLET;ORAL 065400-001 May 15, 2015 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
Gland Pharma Ltd AZITHROMYCIN azithromycin INJECTABLE;INJECTION 065501-001 Nov 9, 2009 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Aurobindo Pharma Ltd AZITHROMYCIN azithromycin TABLET;ORAL 207370-001 Jul 5, 2018 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

Expired US Patents for AZITHROMYCIN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pf Prism Cv ZMAX azithromycin FOR SUSPENSION, EXTENDED RELEASE;ORAL 050797-001 Jun 10, 2005 ⤷  Try a Trial ⤷  Try a Trial
Pfizer ZITHROMAX azithromycin TABLET;ORAL 050784-001 May 24, 2002 ⤷  Try a Trial ⤷  Try a Trial
Pfizer ZITHROMAX azithromycin TABLET;ORAL 050711-001 Jul 18, 1996 ⤷  Try a Trial ⤷  Try a Trial
Thea Pharma AZASITE azithromycin SOLUTION/DROPS;OPHTHALMIC 050810-001 Apr 27, 2007 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for AZITHROMYCIN

Country Patent Number Title Estimated Expiration
Mexico PA04009424 FORMAS DE DOSIFICACION DE AZITROMICINA CON EFECTOS SECUNDARIOS REDUCIDOS. (AZITHROMYCIN DOSAGE FORMS WITH REDUCED SIDE EFFECTS.) ⤷  Try a Trial
Hong Kong 1080367 AZITHROMYCIN DOSAGE FORMS WITH REDUCED SIDE EFFECTS ⤷  Try a Trial
Poland 1537859 ⤷  Try a Trial
Canada 2467611 FORMES PHARMACEUTIQUES D'AZITHROMYCINE AYANT MOINS D'EFFETS SECONDAIRES (AZITHROMYCIN DOSAGE FORMS WITH REDUCED SIDE EFFECTS) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated 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.