AZITHROMYCIN Drug Patent Profile
✉ Email this page to a colleague
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 Lifesciences, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hospira, Norvium Bioscience, Rising, Slate Run Pharma, Sun Pharm Inds Ltd, Teva Parenteral, Alembic, Apotex Corp, Aurobindo Pharma Usa, Bionpharma, Cspc Ouyi, Lupin Ltd, Pharmobedient, Strides Pharma, 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-eight 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 Research Assistant
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: | 63 |
| Raw Ingredient (Bulk) Api Vendors: | 63 |
| Clinical Trials: | 570 |
| Patent Applications: | 3,137 |
| 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 |
See drug prices for AZITHROMYCIN
Recent Clinical Trials for AZITHROMYCIN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Lao-Oxford-Mahosot Hospital Wellcome Trust Research Unit | Phase 2/Phase 3 |
| Mahidol Oxford Tropical Medicine Research Unit | Phase 2/Phase 3 |
| Medical University of Vienna | N/A |
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Bionpharma | AZITHROMYCIN | azithromycin | TABLET;ORAL | 210000-001 | Feb 26, 2019 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Alembic | AZITHROMYCIN | azithromycin | TABLET;ORAL | 211791-001 | Jan 28, 2020 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Cspc Ouyi | AZITHROMYCIN | azithromycin | TABLET;ORAL | 207566-001 | Sep 24, 2018 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sandoz | AZITHROMYCIN | azithromycin | TABLET;ORAL | 065212-001 | Nov 14, 2005 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
