NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 7 pharmaceutical companies such as SAGENT PHARMS INC, AMNEAL, ENDO OPERATIONS and others. It is marketed under 2 brand names, including METHYLPREDNISOLONE ACETATE, PREDNISOLONE ACETATE. Available in 4 different strengths, such as 40MG/ML, 20MG/ML, 80MG/ML and others, and administered through 2 routes including INJECTABLE;INJECTION, SUSPENSION/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 | |
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| {"application_id":"82904","ingredient":"PREDNISOLONE ACETATE","trade_name":"FLO-PRED","family_id":"37dff1132d9a47669693","publication_number":"US7799331B2","cleaned_patent_number":"7799331","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-10-11","publication_date":"2010-09-21","legal_status":"Granted"} | US7799331B2 Formulation | 21 Sep, 2010 | Granted | 11 Oct, 2028 |
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.