NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 2 pharmaceutical companies such as ALTAIRE PHARMS INC, BAUSCH LOMB IRELAND. It is marketed under 2 brand names, including ALTAFLUOR BENOX, FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE. Available in 2 different strengths, such as 0.4%;0.25%, 0.4%;0.3%, and administered through 1 route including SOLUTION/DROPS;OPHTHALMIC.
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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":"70575","ingredient":"BENOXINATE HYDROCHLORIDE; FLUORESCEIN SODIUM","trade_name":"FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE","family_id":"aab9d04d5e7d41c199d1","publication_number":"US10293047B1","cleaned_patent_number":"10293047","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-11-15","publication_date":"2019-05-21","legal_status":"Granted"} | US10293047B2 Formulation | 21 May, 2019 | Granted | 15 Nov, 2037 | |
| {"application_id":"70576","ingredient":"BENOXINATE HYDROCHLORIDE; FLUORESCEIN SODIUM","trade_name":"FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE","family_id":"aab9d04d5e7d41c199d1","publication_number":"US10632197B2","cleaned_patent_number":"10632197","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-11-15","publication_date":"2020-04-28","legal_status":"Granted"} | US10632197B2 Formulation | 28 Apr, 2020 | Granted | 15 Nov, 2037 | |
| {"application_id":"70571","ingredient":"BENOXINATE HYDROCHLORIDE; FLUORESCEIN SODIUM","trade_name":"FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE","family_id":"aab9d04d5e7d41c199d1","publication_number":"US10842872B2","cleaned_patent_number":"10842872","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-11-15","publication_date":"2020-11-24","legal_status":"Granted"} | US10842872B2 | 24 Nov, 2020 | Granted | 15 Nov, 2037 |
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.