NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 11 pharmaceutical companies such as ANI PHARMS, CHARTWELL, ALK ABELLO and others. It is marketed under 6 brand names, including CIPROFLOXACIN EXTENDED RELEASE, CIPROFLOXACIN, OTIPRIO and others. Available in 11 different strengths, such as 425.2MG;EQ 574.9MG BASE, 212.6MG;EQ 287.5MG BASE, 500MG/5ML and others, and administered through 7 routes including TABLET, EXTENDED RELEASE;ORAL, FOR SUSPENSION;ORAL, INJECTABLE, SUSPENSION;OTIC 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":"82529","ingredient":"CIPROFLOXACIN; DEXAMETHASONE","trade_name":"CIPRODEX","family_id":"f2eb0389ba074800af73","publication_number":"US8846650B2","cleaned_patent_number":"8846650","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-06-04","publication_date":"2014-09-30","legal_status":"Granted"} | US8846650B2 Formulation | 30 Sep, 2014 | Granted | 04 Jun, 2025 | |
| {"application_id":"61459","ingredient":"CIPROFLOXACIN","trade_name":"OTIPRIO","family_id":"f6572cbd2e89434bbdde","publication_number":"US9205048B2","cleaned_patent_number":"9205048","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-04-21","publication_date":"2015-12-08","legal_status":"Expired"} | US9205048B2 | 08 Dec, 2015 | Expired | 21 Apr, 2029 | |
| {"application_id":"61464","ingredient":"CIPROFLOXACIN","trade_name":"OTIPRIO","family_id":"f6572cbd2e89434bbdde","publication_number":"US9603796B2","cleaned_patent_number":"9603796","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-04-21","publication_date":"2017-03-28","legal_status":"Granted"} | US9603796B2 Molecular Formulation | 28 Mar, 2017 | Granted | 21 Apr, 2029 | |
| {"application_id":"61476","ingredient":"CIPROFLOXACIN","trade_name":"OTIPRIO","family_id":"f6572cbd2e89434bbdde","publication_number":"US11369566B2","cleaned_patent_number":"11369566","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-04-21","publication_date":"2022-06-28","legal_status":"Granted"} | US11369566B2 Formulation | 28 Jun, 2022 | Granted | 21 Apr, 2029 | |
| {"application_id":"61460","ingredient":"CIPROFLOXACIN","trade_name":"OTIPRIO","family_id":"f6572cbd2e89434bbdde","publication_number":"US9233068B2","cleaned_patent_number":"9233068","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-12-11","publication_date":"2016-01-12","legal_status":"Expired"} | US9233068B2 Formulation | 12 Jan, 2016 | Expired | 11 Dec, 2029 | |
| {"application_id":"71113","ingredient":"CIPROFLOXACIN HYDROCHLORIDE; FLUOCINOLONE ACETONIDE","trade_name":"OTOVEL","family_id":"898d4afccdc640178c0b","publication_number":"US8932610B2","cleaned_patent_number":"8932610","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-03-24","publication_date":"2015-01-13","legal_status":"Granted"} | US8932610B2 Formulation | 13 Jan, 2015 | Granted | 24 Mar, 2030 | |
| {"application_id":"61345","ingredient":"CIPROFLOXACIN","trade_name":"OTIPRIO","family_id":"f6572cbd2e89434bbdde","publication_number":"US8318817B2","cleaned_patent_number":"8318817","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-04-27","publication_date":"2012-11-27","legal_status":"Granted"} | US8318817B2 | 27 Nov, 2012 | Granted | 27 Apr, 2030 | |
| {"application_id":"61547","ingredient":"CIPROFLOXACIN","trade_name":"OTIPRIO","family_id":"","publication_number":"US9220796B1","cleaned_patent_number":"9220796","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-07-01","publication_date":"2015-12-29","legal_status":"Granted"} | US9220796B2 Formulation | 29 Dec, 2015 | Granted | 01 Jul, 2035 | |
| {"application_id":"61542","ingredient":"CIPROFLOXACIN","trade_name":"OTIPRIO","family_id":"bb4b86359c8d443b9f58","publication_number":"US11040004B2","cleaned_patent_number":"11040004","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-11-12","publication_date":"2021-06-22","legal_status":"Granted"} | US11040004B2 | 22 Jun, 2021 | Granted | 12 Nov, 2037 | |
| {"application_id":"61560","ingredient":"CIPROFLOXACIN","trade_name":"OTIPRIO","family_id":"7679381356b54959bcdb","publication_number":"US11246863B2","cleaned_patent_number":"11246863","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-11-27","publication_date":"2022-02-15","legal_status":"Granted"} | US11246863B2 Formulation | 15 Feb, 2022 | Granted | 27 Nov, 2038 |
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.