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.
Summary for AZITHROMYCIN
US Patents: | 0 |
Applicants: | 32 |
NDAs: | 63 |
Finished Product Suppliers / Packagers: | 57 |
Raw Ingredient (Bulk) Api Vendors: | 75 |
Clinical Trials: | 559 |
Patent Applications: | 1,679 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for AZITHROMYCIN |
Drug Sales Revenues: | Drug sales revenues 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
Sponsor | Phase |
---|---|
Infectious Diseases Clinical Research Consortium | Phase 4 |
Newcastle University | Phase 4 |
University College London Hospitals | Phase 4 |
Pharmacology for AZITHROMYCIN
Drug Class | Macrolide Antimicrobial |
Medical Subject Heading (MeSH) Categories for AZITHROMYCIN
Anatomical Therapeutic Chemical (ATC) Classes 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 |