NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 14 pharmaceutical companies such as SANDOZ, CUMBERLAND, AUROBINDO PHARMA LTD and others. It is marketed under 7 brand names, including AMOXICILLIN AND CLAVULANATE POTASSIUM, OMECLAMOX-PAK, LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED) and others. Available in 19 different strengths, such as 1GM;EQ 62.5MG BASE, 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG, 200MG/5ML;EQ 28.5MG BASE/5ML and others, and administered through 10 routes including TABLET, EXTENDED RELEASE;ORAL, CAPSULE, TABLET, CAPSULE, DELAYED RELEASE;ORAL, FOR SUSPENSION;ORAL and others.
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Licensing: 14 potential partnersUS Launch window: Loading launch window...
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FDA approval history for this ingredient
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Key expiration dates for US patents covering this ingredient
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Latest drug strengths approved by FDA
| Strength | Route of Administration | Companies | Latest Approval Date |
|---|
Patents approved by the FDA for the ingredient
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Patent Number | Publication Date | Legal Status | Patent Expiry Date | |
|---|---|---|---|---|---|
| {"application_id":"86697","ingredient":"AMOXICILLIN","trade_name":"MOXATAG","family_id":"da3faeb0e5b745aaa8ce","publication_number":"US8357394B2","cleaned_patent_number":"8357394","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-12-08","publication_date":"2013-01-22","legal_status":"Granted"} | US8357394B2 Formulation | 22 Jan, 2013 | Granted | 08 Dec, 2026 | |
| {"application_id":"86698","ingredient":"AMOXICILLIN","trade_name":"MOXATAG","family_id":"da3faeb0e5b745aaa8ce","publication_number":"US8778924B2","cleaned_patent_number":"8778924","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-12-08","publication_date":"2014-07-15","legal_status":"Granted"} | US8778924B2 Molecular Formulation | 15 Jul, 2014 | Granted | 08 Dec, 2026 | |
| {"application_id":"86688","ingredient":"AMOXICILLIN","trade_name":"MOXATAG","family_id":"da3faeb0e5b745aaa8ce","publication_number":"US8299052B2","cleaned_patent_number":"8299052","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-05-07","publication_date":"2012-10-30","legal_status":"Granted"} | US8299052B2 | 30 Oct, 2012 | Granted | 07 May, 2027 | |
| {"application_id":"45295","ingredient":"AMOXICILLIN; CLARITHROMYCIN; VONOPRAZAN FUMARATE","trade_name":"VOQUEZNA DUAL PAK","family_id":"3f3ca36210f34b04ac75","publication_number":"US7977488B2","cleaned_patent_number":"7977488","drug_product_flag":"-","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-08-11","publication_date":"2011-07-12","legal_status":"Granted"} | US7977488B2 Molecular | 12 Jul, 2011 | Granted | 11 Aug, 2028 | |
| {"application_id":"45355","ingredient":"AMOXICILLIN; CLARITHROMYCIN; VONOPRAZAN FUMARATE","trade_name":"VOQUEZNA DUAL PAK","family_id":"ba356d535068419e9860","publication_number":"US9186411B2","cleaned_patent_number":"9186411","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-08-11","publication_date":"2015-11-17","legal_status":"Granted"} | US9186411B2 Formulation | 17 Nov, 2015 | Granted | 11 Aug, 2030 | |
| {"application_id":"43993","ingredient":"AMOXICILLIN; OMEPRAZOLE MAGNESIUM; RIFABUTIN","trade_name":"TALICIA","family_id":"771a08de1e60447691ed","publication_number":"US9603806B2","cleaned_patent_number":"9603806","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-02-12","publication_date":"2017-03-28","legal_status":"Granted"} | US9603806B2 Formulation | 28 Mar, 2017 | Granted | 12 Feb, 2034 | |
| {"application_id":"44022","ingredient":"AMOXICILLIN; OMEPRAZOLE MAGNESIUM; RIFABUTIN","trade_name":"TALICIA","family_id":"771a08de1e60447691ed","publication_number":"US11135172B2","cleaned_patent_number":"11135172","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-02-12","publication_date":"2021-10-05","legal_status":"Granted"} | US11135172B2 Formulation | 05 Oct, 2021 | Granted | 12 Feb, 2034 | |
| {"application_id":"44023","ingredient":"AMOXICILLIN; OMEPRAZOLE MAGNESIUM; RIFABUTIN","trade_name":"TALICIA","family_id":"771a08de1e60447691ed","publication_number":"US11931463B2","cleaned_patent_number":"11931463","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-02-12","publication_date":"2024-03-19","legal_status":"Granted"} | US11931463B2 Formulation | 19 Mar, 2024 | Granted | 12 Feb, 2034 | |
| {"application_id":"44018","ingredient":"AMOXICILLIN; OMEPRAZOLE MAGNESIUM; RIFABUTIN","trade_name":"TALICIA","family_id":"771a08de1e60447691ed","publication_number":"US9050263B2","cleaned_patent_number":"9050263","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-02-12","publication_date":"2015-06-09","legal_status":"Patented case"} | US9050263B2 Formulation | 09 Jun, 2015 | Patented case | 12 Feb, 2034 | |
| {"application_id":"44020","ingredient":"AMOXICILLIN; OMEPRAZOLE MAGNESIUM; RIFABUTIN","trade_name":"TALICIA","family_id":"771a08de1e60447691ed","publication_number":"US10238606B2","cleaned_patent_number":"10238606","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-02-12","publication_date":"2019-03-26","legal_status":"Granted"} | US10238606B2 Formulation | 26 Mar, 2019 | Granted | 12 Feb, 2034 | |
| {"application_id":"44019","ingredient":"AMOXICILLIN; OMEPRAZOLE MAGNESIUM; RIFABUTIN","trade_name":"TALICIA","family_id":"771a08de1e60447691ed","publication_number":"US9498445B2","cleaned_patent_number":"9498445","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-02-12","publication_date":"2016-11-22","legal_status":"Granted"} | US9498445B2 Formulation | 22 Nov, 2016 | Granted | 12 Feb, 2034 | |
| {"application_id":"122881","ingredient":"AMOXICILLIN; OMEPRAZOLE MAGNESIUM; RIFABUTIN","trade_name":"TALICIA","family_id":"","publication_number":"US11878011B2","cleaned_patent_number":"11878011","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2042-05-27","publication_date":"2024-01-23","legal_status":"Granted"} | US11878011B2 | 23 Jan, 2024 | Granted | 27 May, 2042 |
Latest clinical trials and research studies for this ingredient
| NCT ID | Title | Status | Phase | Conditions | Start Date | Completion Date |
|---|
Manufacturing Locations
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Note: Patent expirations and exclusivity timelines are dynamic and may shift based on litigation, regulatory extensions, and maintenance filings. Regular monitoring is advised.