NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 27 pharmaceutical companies such as ALEMBIC, COSETTE, CHARTWELL RX and others. It is marketed under 6 brand names, including METRONIDAZOLE, NUVESSA, METRONIDAZOLE IN PLASTIC CONTAINER and others. Available in 11 different strengths, such as 750MG, 0.75%, 1% and others, and administered through 9 routes including TABLET, EXTENDED RELEASE;ORAL, GEL;TOPICAL, TABLET;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":"59813","ingredient":"METRONIDAZOLE","trade_name":"NUVESSA","family_id":"84d87eb6e26e46828eee","publication_number":"US8877792B2","cleaned_patent_number":"8877792","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-02-02","publication_date":"2014-11-04","legal_status":"Granted"} | US8877792B2 Formulation | 04 Nov, 2014 | Granted | 02 Feb, 2028 | |
| {"application_id":"59812","ingredient":"METRONIDAZOLE","trade_name":"NUVESSA","family_id":"84d87eb6e26e46828eee","publication_number":"US7893097B2","cleaned_patent_number":"7893097","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-02-19","publication_date":"2011-02-22","legal_status":"Granted"} | US7893097B2 Formulation | 22 Feb, 2011 | Granted | 19 Feb, 2028 | |
| {"application_id":"59810","ingredient":"METRONIDAZOLE","trade_name":"NUVESSA","family_id":"84d87eb6e26e46828eee","publication_number":"US8658678B2","cleaned_patent_number":"8658678","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-06-27","publication_date":"2014-02-25","legal_status":"Granted"} | US8658678B2 | 25 Feb, 2014 | Granted | 27 Jun, 2028 | |
| {"application_id":"59789","ingredient":"METRONIDAZOLE","trade_name":"NUVESSA","family_id":"ebc69c8903744497910c","publication_number":"US9198858B2","cleaned_patent_number":"9198858","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-06-28","publication_date":"2015-12-01","legal_status":"Granted"} | US9198858B2 | 01 Dec, 2015 | Granted | 28 Jun, 2032 | |
| {"application_id":"59803","ingredient":"METRONIDAZOLE","trade_name":"NUVESSA","family_id":"ebc69c8903744497910c","publication_number":"US10596155B2","cleaned_patent_number":"10596155","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-06-28","publication_date":"2020-03-24","legal_status":"Granted"} | US10596155B2 Formulation | 24 Mar, 2020 | Granted | 28 Jun, 2032 | |
| {"application_id":"59801","ingredient":"METRONIDAZOLE","trade_name":"NUVESSA","family_id":"ebc69c8903744497910c","publication_number":"US8946276B2","cleaned_patent_number":"8946276","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-06-28","publication_date":"2015-02-03","legal_status":"Granted"} | US8946276B2 | 03 Feb, 2015 | Granted | 28 Jun, 2032 | |
| {"application_id":"59802","ingredient":"METRONIDAZOLE","trade_name":"NUVESSA","family_id":"ebc69c8903744497910c","publication_number":"US10238634B2","cleaned_patent_number":"10238634","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-06-28","publication_date":"2019-03-26","legal_status":"Granted"} | US10238634B2 Formulation | 26 Mar, 2019 | Granted | 28 Jun, 2032 | |
| {"application_id":"117545","ingredient":"METRONIDAZOLE","trade_name":"LIKMEZ","family_id":"2c0cd7b1327f4fba99d3","publication_number":"US2023086660A1","cleaned_patent_number":"12257236","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2039-01-16","publication_date":"2023-03-23","legal_status":"Granted"} | US12257236B2 Formulation | 23 Mar, 2023 | Granted | 16 Jan, 2039 | |
| {"application_id":"117540","ingredient":"METRONIDAZOLE","trade_name":"LIKMEZ","family_id":"2c0cd7b1327f4fba99d3","publication_number":"US11541035B2","cleaned_patent_number":"11541035","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2039-10-04","publication_date":"2023-01-03","legal_status":"Granted"} | US11541035B2 Formulation | 03 Jan, 2023 | Granted | 04 Oct, 2039 |
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.