Amoxicillin; clavulanate potassium - Generic Drug Details
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What are the generic drug sources for amoxicillin; clavulanate potassium and what is the scope of freedom to operate?
Amoxicillin; clavulanate potassium
is the generic ingredient in nine branded drugs marketed by Aurobindo Pharma, Aurobindo Pharma Ltd, Cipla, Deva Holding As, Hikma Pharms, Micro Labs, Micro Labs Ltd India, Sandoz, Sandoz Inc, Sun Pharm Inds Ltd, Teva, Us Antibiotics, Chartwell Rx, Apotex Inc, and Teva Pharms Usa, and is included in forty-nine NDAs. Additional information is available in the individual branded drug profile pages.Thirty-six suppliers are listed for this compound.
Summary for amoxicillin; clavulanate potassium
US Patents: | 0 |
Tradenames: | 9 |
Applicants: | 15 |
NDAs: | 49 |
Finished Product Suppliers / Packagers: | 36 |
Raw Ingredient (Bulk) Api Vendors: | 16 |
Clinical Trials: | 18 |
Patent Applications: | 1,492 |
DailyMed Link: | amoxicillin; clavulanate potassium at DailyMed |
Recent Clinical Trials for amoxicillin; clavulanate potassium
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Second Affiliated Hospital of Wenzhou Medical University | N/A |
Haining Health-Coming Biotech Co., Ltd. | Phase 2 |
Alphacait, LLC | Phase 2 |
Pharmacology for amoxicillin; clavulanate potassium
Drug Class | Penicillin-class Antibacterial beta Lactamase Inhibitor |
Mechanism of Action | beta Lactamase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for amoxicillin; clavulanate potassium
Paragraph IV (Patent) Challenges for AMOXICILLIN; CLAVULANATE POTASSIUM
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
AUGMENTIN XR | Extended-release Tablets | amoxicillin; clavulanate potassium | 1000 mg/62.5 mg | 050785 | 1 | 2009-01-21 |
US Patents and Regulatory Information for amoxicillin; clavulanate potassium
Expired US Patents for amoxicillin; clavulanate potassium
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Us Antibiotics | AUGMENTIN XR | amoxicillin; clavulanate potassium | TABLET, EXTENDED RELEASE;ORAL | 050785-001 | Sep 25, 2002 | ⤷ Sign Up | ⤷ Sign Up |
Us Antibiotics | AUGMENTIN XR | amoxicillin; clavulanate potassium | TABLET, EXTENDED RELEASE;ORAL | 050785-001 | Sep 25, 2002 | ⤷ Sign Up | ⤷ Sign Up |
Us Antibiotics | AUGMENTIN XR | amoxicillin; clavulanate potassium | TABLET, EXTENDED RELEASE;ORAL | 050785-001 | Sep 25, 2002 | ⤷ Sign Up | ⤷ Sign Up |
Us Antibiotics | AUGMENTIN XR | amoxicillin; clavulanate potassium | TABLET, EXTENDED RELEASE;ORAL | 050785-001 | Sep 25, 2002 | ⤷ Sign Up | ⤷ Sign Up |
Us Antibiotics | AUGMENTIN XR | amoxicillin; clavulanate potassium | TABLET, EXTENDED RELEASE;ORAL | 050785-001 | Sep 25, 2002 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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