AMOXICILLIN; CLAVULANATE POTASSIUM - Generic Drug Details
✉ Email this page to a colleague
What are the generic 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-eight suppliers are listed for this compound.
Summary for AMOXICILLIN; CLAVULANATE POTASSIUM
US Patents: | 0 |
Tradenames: | 9 |
Applicants: | 15 |
NDAs: | 49 |
Finished Product Suppliers / Packagers: | 38 |
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 |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.