AMOXICILLIN Drug Patent Profile
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When do Amoxicillin patents expire, and what generic alternatives are available?
Amoxicillin is a drug marketed by Aurobindo, Chartwell, Hikma Pharms, Labs Atral, Micro Labs, Mylan, Sandoz, Strides Pharma, Sun Pharm Inds Ltd, Teva, Aurobindo Pharma Ltd, Chartwell Rx, Endo Operations, Hikma, Apothecon, Aurobindo Pharma, Cipla, Deva Holding As, Micro Labs Ltd India, Sandoz Inc, Apotex Inc, and Teva Pharms Usa. and is included in eighty-five NDAs.
The generic ingredient in AMOXICILLIN is amoxicillin; clavulanate potassium. There are forty-six drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the amoxicillin; clavulanate potassium profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Amoxicillin
A generic version of AMOXICILLIN was approved as amoxicillin; clavulanate potassium by SANDOZ on March 14th, 2002.
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Questions you can ask:
- What is the 5 year forecast for AMOXICILLIN?
- What are the global sales for AMOXICILLIN?
- What is Average Wholesale Price for AMOXICILLIN?
Summary for AMOXICILLIN
| US Patents: | 0 |
| Applicants: | 22 |
| NDAs: | 85 |
| Finished Product Suppliers / Packagers: | 35 |
| Raw Ingredient (Bulk) Api Vendors: | 68 |
| Clinical Trials: | 581 |
| Patent Applications: | 2,655 |
| Drug Prices: | Drug price information for AMOXICILLIN |
| Drug Sales Revenues: | Drug sales revenues for AMOXICILLIN |
| What excipients (inactive ingredients) are in AMOXICILLIN? | AMOXICILLIN excipients list |
| DailyMed Link: | AMOXICILLIN at DailyMed |
See drug prices for AMOXICILLIN
Recent Clinical Trials for AMOXICILLIN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Rutgers, The State University of New Jersey | Phase 3 |
| National Institute of Dental and Craniofacial Research (NIDCR) | Phase 3 |
| National Dental PBRN | Phase 3 |
Pharmacology for AMOXICILLIN
| Drug Class | Penicillin-class Antibacterial |
Medical Subject Heading (MeSH) Categories for AMOXICILLIN
Anatomical Therapeutic Chemical (ATC) Classes for AMOXICILLIN
US Patents and Regulatory Information for AMOXICILLIN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sandoz | AMOXICILLIN | amoxicillin | TABLET;ORAL | 065228-001 | Jul 13, 2005 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sun Pharm Inds Ltd | AMOXICILLIN AND CLAVULANATE POTASSIUM | amoxicillin; clavulanate potassium | FOR SUSPENSION;ORAL | 065207-002 | Jan 30, 2007 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sandoz | AMOXICILLIN | amoxicillin | FOR SUSPENSION;ORAL | 065378-001 | Mar 26, 2007 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Endo Operations | AMOXICILLIN | amoxicillin | FOR SUSPENSION;ORAL | 062927-001 | Nov 25, 1988 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Deva Holding As | AMOXICILLIN AND CLAVULANATE POTASSIUM | amoxicillin; clavulanate potassium | FOR SUSPENSION;ORAL | 210416-001 | Dec 11, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Apotex Inc | AMOXICILLIN AND CLAVULANATE POTASSIUM | amoxicillin; clavulanate potassium | TABLET;ORAL | 065317-003 | Oct 20, 2008 | DISCN | 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 |
