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 Intl, Sun Pharm Inds Ltd, Teva, Aurobindo Pharma Ltd, Chartwell Rx, Hikma, Ph Health, 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-two 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: | 38 |
| Raw Ingredient (Bulk) Api Vendors: | 1 |
| Clinical Trials: | 680 |
| Patent Applications: | 2,004 |
| 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 |
Recent Clinical Trials for AMOXICILLIN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Guanxian People's Hospital | NA |
| Yantai Zhifu Hospital | NA |
| Agnaldo Rocha de Souza Junior | NA |
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 | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Sun Pharm Inds Ltd | AMOXICILLIN AND CLAVULANATE POTASSIUM | amoxicillin; clavulanate potassium | FOR SUSPENSION;ORAL | 065207-002 | Jan 30, 2007 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Sandoz | AMOXICILLIN | amoxicillin | FOR SUSPENSION;ORAL | 065378-001 | Mar 26, 2007 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Hikma | AMOXICILLIN | amoxicillin | FOR SUSPENSION;ORAL | 065322-002 | Jun 19, 2006 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Deva Holding As | AMOXICILLIN AND CLAVULANATE POTASSIUM | amoxicillin; clavulanate potassium | FOR SUSPENSION;ORAL | 210416-001 | Dec 11, 2023 | 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 |
