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Azithromycinis 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.
Summary for azithromycin
|Drug Master File Entries:||32|
|Finished Product Suppliers / Packagers:||57|
|Raw Ingredient (Bulk) Api Vendors:||66|
|Formulation / Manufacturing:||see details|
|Drug Prices:||Drug price trends for azithromycin|
|Drug Sales Revenues:||Drug sales revenues for azithromycin|
|Patent Litigation and PTAB cases:||See patent lawsuits and PTAB cases for azithromycin|
|What excipients (inactive ingredients) are in azithromycin?||azithromycin excipients list|
|DailyMed Link:||azithromycin at DailyMed|
Recent Clinical Trials for azithromycin
Identify potential brand extensions & 505(b)(2) entrants
|Iterum Therapeutics, International Limited||Phase 3|
|Copenhagen Studies on Asthma in Childhood||Phase 2|
|Waterbury Hospital||Phase 3|
Generic filers with tentative approvals for AZITHROMYCIN
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
|Drug Class||Macrolide Antimicrobial |
Medical Subject Heading (MeSH) Categories 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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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.