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, Pliva, Sandoz, Taro, Teva Pharms, Zhejiang Poly Pharm, Zydus Lifesciences, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hospira, Pharmobedient, Rising, Slate Run Pharma, Sun Pharm Inds Ltd, Teva Parenteral, Alembic, Apotex Corp, Aurobindo Pharma Usa, Bionpharma, Carlsbad, Cspc Ouyi, Extrovis, Lupin, Strides Pharma, Sunshine, Teva, 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. Fifty-nine 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.
AI Deep Research
Questions you can ask:
- What is the 5 year forecast for AZITHROMYCIN?
- What are the global sales for AZITHROMYCIN?
- What is Average Wholesale Price for AZITHROMYCIN?
Summary for AZITHROMYCIN
| US Patents: | 0 |
| Applicants: | 32 |
| NDAs: | 63 |
| Finished Product Suppliers / Packagers: | 57 |
| Raw Ingredient (Bulk) Api Vendors: | 75 |
| Clinical Trials: | 603 |
| 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 |
|---|---|
| Korea National Institute of Health | PHASE4 |
| Young June Choe | PHASE4 |
| Korea Disease Control and Prevention Agency | PHASE4 |
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 | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Bionpharma | AZITHROMYCIN | azithromycin | TABLET;ORAL | 210000-001 | Feb 26, 2019 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Alembic | AZITHROMYCIN | azithromycin | TABLET;ORAL | 211791-001 | Jan 28, 2020 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Cspc Ouyi | AZITHROMYCIN | azithromycin | TABLET;ORAL | 208250-001 | Apr 17, 2019 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Pliva | AZITHROMYCIN | azithromycin | TABLET;ORAL | 065218-001 | Nov 14, 2005 | AB | RX | No | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Carlsbad | AZITHROMYCIN | azithromycin | TABLET;ORAL | 211068-001 | May 8, 2020 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Cspc Ouyi | AZITHROMYCIN | azithromycin | TABLET;ORAL | 208249-001 | Oct 25, 2018 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
