NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 13 pharmaceutical companies such as CUMBERLAND, AUROBINDO, ESJAY PHARMA and others. It is marketed under 4 brand names, including OMECLAMOX-PAK, CLARITHROMYCIN, LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED) and others. Available in 5 different strengths, such as 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG, 500MG, 250MG and others, and administered through 5 routes including CAPSULE, TABLET, CAPSULE, DELAYED RELEASE;ORAL, TABLET;ORAL, CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL and others.
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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 |
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Patents approved by the FDA for the ingredient
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Patent Number | Publication Date | Legal Status | Patent Expiry Date | |
|---|---|---|---|---|---|
| {"application_id":"45295","ingredient":"AMOXICILLIN; CLARITHROMYCIN; VONOPRAZAN FUMARATE","trade_name":"VOQUEZNA TRIPLE 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 TRIPLE 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 |
Latest clinical trials and research studies for this ingredient
| NCT ID | Title | Status | Phase | Conditions | Start Date | Completion Date |
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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.