NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 17 pharmaceutical companies such as AMNEAL, PADAGIS ISRAEL, ALIMERA SCIENCES INC and others. It is marketed under 7 brand names, including FLUOCINOLONE ACETONIDE, ILUVIEN, OTOVEL and others. Available in 5 different strengths, such as 0.01%, 0.19MG, EQ 0.3% BASE;0.025% and others, and administered through 6 routes including OIL;TOPICAL, OIL/DROPS;OTIC, IMPLANT;INTRAVITREAL 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":"60741","ingredient":"FLUOCINOLONE ACETONIDE","trade_name":"ILUVIEN","family_id":"2109e6b553c8490ea48a","publication_number":"US8871241B2","cleaned_patent_number":"8871241","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-08-12","publication_date":"2014-10-28","legal_status":"Granted"} | US8871241B2 Formulation | 28 Oct, 2014 | Granted | 12 Aug, 2027 | |
| {"application_id":"108077","ingredient":"FLUOCINOLONE ACETONIDE","trade_name":"YUTIQ","family_id":"6c6426c6fe5e446caecb","publication_number":"US7998108B2","cleaned_patent_number":"7998108","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-01-12","publication_date":"2011-08-16","legal_status":"Granted"} | US7998108B2 Formulation | 16 Aug, 2011 | Granted | 12 Jan, 2028 | |
| {"application_id":"164421","ingredient":"FLUOCINOLONE ACETONIDE","trade_name":"ILUVIEN","family_id":"7a4bb234c27e44cd8ba9","publication_number":"US9849027B2","cleaned_patent_number":"9849027","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-11-07","publication_date":"2017-12-26","legal_status":"Patented case"} | US9849027B2 Formulation | 26 Dec, 2017 | Patented case | 07 Nov, 2028 | |
| {"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 |
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.