Details for New Drug Application (NDA): 219910
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NDA 219910 describes EPIOXA HD/EPIOXA KIT, which is a drug marketed by Glaukos and is included in one NDA. Additional details are available on the EPIOXA HD/EPIOXA KIT profile page.
The generic ingredient in EPIOXA HD/EPIOXA KIT is riboflavin 5'-phosphate. There are ten drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the riboflavin 5'-phosphate profile page.
The generic ingredient in EPIOXA HD/EPIOXA KIT is riboflavin 5'-phosphate. There are ten drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the riboflavin 5'-phosphate profile page.
Summary for 219910
| Tradename: | EPIOXA HD/EPIOXA KIT |
| Applicant: | Glaukos |
| Ingredient: | riboflavin 5'-phosphate |
| Patents: | 0 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 219910
Generic Entry Date for 219910*:
Constraining patent/regulatory exclusivity:
NEW PRODUCT Dosage:
SOLUTION/DROPS;OPHTHALMIC |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 0.239%;0.177% | ||||
| Approval Date: | Oct 17, 2025 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Oct 17, 2028 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
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