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Amoxicillin - Generic Drug Details
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What are the generic sources for amoxicillin and what is the scope of patent protection?
Amoxicillin
is the generic ingredient in twenty-three branded drugs marketed by Aurobindo, Belcher Pharms, Dava Pharms Inc, Hikma Pharms, Labs Atral, Mylan, Sandoz, Sun Pharm Inds Ltd, Teva, Glaxosmithkline, Neopharma, Apothecon, Parke Davis, Wyeth Ayerst, Aurobindo Pharma Ltd, Hikma, Wockhardt Bio Ag, Pragma, Ranbaxy Labs Ltd, Ani Pharms Inc, Rising, Sandoz Inc, Takeda Pharms Usa, Cumberland Pharms, Apotex Inc, Micro Labs Ltd India, Teva Pharms Usa, and Redhill, and is included in one hundred and sixteen NDAs. There are fifteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.Amoxicillin has thirty-seven patent family members in six countries.
There are forty-six drug master file entries for amoxicillin. Twenty-seven suppliers are listed for this compound.
Summary for amoxicillin
International Patents: | 37 |
US Patents: | 15 |
Tradenames: | 23 |
Applicants: | 28 |
NDAs: | 116 |
Drug Master File Entries: | 46 |
Suppliers / Packagers: | 27 |
Bulk Api Vendors: | 63 |
Clinical Trials: | 443 |
Patent Applications: | 7,046 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends 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 |
---|---|
University of Lausanne | Phase 4 |
Poitiers University Hospital | Phase 3 |
Iqvia Pty Ltd | Phase 4 |
Pharmacology for amoxicillin
Drug Class | Penicillin-class Antibacterial beta Lactamase Inhibitor |
Mechanism of Action | beta Lactamase Inhibitors |
Medical Subject Heading (MeSH) Categories 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Hikma | AMOXICILLIN | amoxicillin | TABLET, CHEWABLE;ORAL | 205274-001 | Jun 25, 2020 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Aurobindo Pharma Ltd | AMOXICILLIN | amoxicillin | TABLET, FOR SUSPENSION;ORAL | 065324-002 | Jan 17, 2007 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
Sandoz | AMOXICILLIN AND CLAVULANATE POTASSIUM | amoxicillin; clavulanate potassium | FOR SUSPENSION;ORAL | 065066-001 | Jun 5, 2002 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Neopharma | AUGMENTIN XR | amoxicillin; clavulanate potassium | TABLET, EXTENDED RELEASE;ORAL | 050785-001 | Sep 25, 2002 | DISCN | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for amoxicillin
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Pragma | MOXATAG | amoxicillin | TABLET, EXTENDED RELEASE;ORAL | 050813-001 | Jan 23, 2008 | Start Trial | Start Trial |
Pragma | MOXATAG | amoxicillin | TABLET, EXTENDED RELEASE;ORAL | 050813-001 | Jan 23, 2008 | Start Trial | Start Trial |
Pragma | MOXATAG | amoxicillin | TABLET, EXTENDED RELEASE;ORAL | 050813-001 | Jan 23, 2008 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for amoxicillin
Country | Patent Number | Estimated Expiration |
---|---|---|
Australia | 2006351475 | Start Trial |
Australia | 2003262626 | Start Trial |
Japan | 2005538121 | Start Trial |
Japan | 2010511607 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
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