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-nine suppliers are listed for this compound.
Summary for amoxicillin; clavulanate potassium
| US Patents: | 0 |
| Tradenames: | 9 |
| Applicants: | 15 |
| NDAs: | 49 |
| Finished Product Suppliers / Packagers: | 39 |
| 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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Deva Holding As | AMOXICILLIN AND CLAVULANATE POTASSIUM | amoxicillin; clavulanate potassium | FOR SUSPENSION;ORAL | 209351-001 | Sep 13, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sandoz | AMOXICILLIN AND CLAVULANATE POTASSIUM | amoxicillin; clavulanate potassium | TABLET, EXTENDED RELEASE;ORAL | 090227-001 | Apr 21, 2010 | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Us Antibiotics | AUGMENTIN '400' | amoxicillin; clavulanate potassium | TABLET, CHEWABLE;ORAL | 050726-002 | May 31, 1996 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Micro Labs Ltd India | AMOXICILLIN AND CLAVULANATE POTASSIUM | amoxicillin; clavulanate potassium | TABLET;ORAL | 205707-001 | Dec 30, 2016 | AB | RX | 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 | |||
| >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; 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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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.
ISSN: 2162-2639
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