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Last Updated: October 22, 2021

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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 patent protection?

Azithromycin is the generic ingredient in five branded drugs marketed by Pfizer, Pf Prism Cv, Amneal, Aurobindo Pharma Ltd, Epic Pharma Llc, Lupin Ltd, Pliva, Sandoz, Taro, Teva Pharms, Zydus, Fresenius Kabi Usa, Gland Pharma Ltd, Hainan Poly Pharm, Hikma Pharms, Hospira, Mylan Asi, Mylan Labs Ltd, Sun Pharm Inds Ltd, Teva Parenteral, Akorn, Alembic Pharms Ltd, Apotex Corp, Bionpharma Inc, Cspc Ouyi, Mylan, Sunshine, Teva, Wockhardt, and Yung Shin Pharm, and is included in sixty-seven 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-seven 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
Iterum Therapeutics, International LimitedPhase 3
Copenhagen Studies on Asthma in ChildhoodPhase 2
Waterbury HospitalPhase 3

See all azithromycin clinical trials

Generic filers with tentative approvals for AZITHROMYCIN
Applicant Application No. Strength Dosage Form
⤷  Free Forever Trial⤷  Free Forever Trial1%SOLUTION; OPHTHALMIC
⤷  Free Forever Trial⤷  Free Forever TrialEQ 200MG BASE/5MLFOR SUSPENSION;ORAL
⤷  Free Forever Trial⤷  Free Forever 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
Mylan Labs Ltd AZITHROMYCIN azithromycin INJECTABLE;INJECTION 204732-001 Jan 26, 2017 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Hospira AZITHROMYCIN azithromycin INJECTABLE;INJECTION 065500-001 Jun 26, 2009 AP RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Lupin Ltd AZITHROMYCIN azithromycin FOR SUSPENSION;ORAL 065488-002 May 15, 2015 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Cspc Ouyi AZITHROMYCIN azithromycin TABLET;ORAL 208250-001 Apr 17, 2019 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Wockhardt AZITHROMYCIN azithromycin TABLET;ORAL 065302-003 Feb 11, 2008 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Teva AZITHROMYCIN azithromycin TABLET;ORAL 065153-001 Nov 14, 2005 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Akorn AZASITE azithromycin SOLUTION/DROPS;OPHTHALMIC 050810-001 Apr 27, 2007 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever 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 FOR SUSPENSION;ORAL 050693-001 Sep 28, 1994 ⤷  Free Forever Trial ⤷  Free Forever Trial
Pfizer ZITHROMAX azithromycin TABLET;ORAL 050730-001 Jun 12, 1996 ⤷  Free Forever Trial ⤷  Free Forever Trial
Pfizer ZITHROMAX azithromycin TABLET;ORAL 050711-001 Jul 18, 1996 ⤷  Free Forever Trial ⤷  Free Forever Trial
Akorn AZASITE azithromycin SOLUTION/DROPS;OPHTHALMIC 050810-001 Apr 27, 2007 ⤷  Free Forever Trial ⤷  Free Forever Trial
Pf Prism Cv ZMAX azithromycin FOR SUSPENSION, EXTENDED RELEASE;ORAL 050797-001 Jun 10, 2005 ⤷  Free Forever Trial ⤷  Free Forever Trial
Pfizer ZITHROMAX azithromycin INJECTABLE;INJECTION 050733-001 Jan 30, 1997 ⤷  Free Forever Trial ⤷  Free Forever Trial
Akorn AZASITE azithromycin SOLUTION/DROPS;OPHTHALMIC 050810-001 Apr 27, 2007 ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for azithromycin

Country Patent Number Estimated Expiration
Chile 2004001501 ⤷  Free Forever Trial
Poland 1537859 ⤷  Free Forever Trial
Japan 4602711 ⤷  Free Forever Trial
Peru 20050573 ⤷  Free Forever Trial
Eurasian Patent Organization 200401216 ⤷  Free Forever Trial
Tunisia SN05319 ⤷  Free Forever Trial
South Korea 100906290 ⤷  Free Forever Trial
>Country >Patent Number >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Express Scripts
Merck
McKinsey
Medtronic
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.