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. It is available from one supplier. Additional details are available on the EPIOXA HD/EPIOXA KIT profile page.
The generic ingredient in EPIOXA HD/EPIOXA KIT is riboflavin 5'-phosphate sodium. 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 sodium profile page.
The generic ingredient in EPIOXA HD/EPIOXA KIT is riboflavin 5'-phosphate sodium. 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 sodium profile page.
Summary for 219910
| Tradename: | EPIOXA HD/EPIOXA KIT |
| Applicant: | Glaukos |
| Ingredient: | riboflavin 5'-phosphate sodium |
| 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.
Medical Subject Heading (MeSH) Categories for 219910
Suppliers and Packaging for NDA: 219910
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| EPIOXA HD/EPIOXA KIT | riboflavin 5'-phosphate sodium | SOLUTION/DROPS;OPHTHALMIC | 219910 | NDA | Glaukos Corporation | 25357-024 | 25357-024-01 | 1 KIT in 1 CARTON (25357-024-01) * 1 SYRINGE, GLASS in 1 POUCH (25357-026-01) / 2 mL in 1 SYRINGE, GLASS * 1 SYRINGE, GLASS in 1 POUCH (25357-027-01) / 2 mL in 1 SYRINGE, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | EQ 0.239% BASE/ML;EQ 0.177% BASE/ML | ||||
| Approval Date: | Oct 17, 2025 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Oct 17, 2028 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
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