Details for New Drug Application (NDA): 203491
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The generic ingredient in ILEVRO is nepafenac. There are eight drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the nepafenac profile page.
Summary for 203491
Tradename: | ILEVRO |
Applicant: | Harrow Eye |
Ingredient: | nepafenac |
Patents: | 3 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 203491
Generic Entry Date for 203491*:
Constraining patent/regulatory exclusivity:
Dosage:
SUSPENSION/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.
Pharmacology for NDA: 203491
Mechanism of Action | Cyclooxygenase Inhibitors |
Suppliers and Packaging for NDA: 203491
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ILEVRO | nepafenac | SUSPENSION/DROPS;OPHTHALMIC | 203491 | NDA | Novartis Pharmaceuticals Corporation | 0078-0743 | 0078-0743-03 | 1 BOTTLE in 1 CARTON (0078-0743-03) / 3 mL in 1 BOTTLE |
ILEVRO | nepafenac | SUSPENSION/DROPS;OPHTHALMIC | 203491 | NDA | Novartis Pharmaceuticals Corporation | 0078-0743 | 0078-0743-96 | 1 BOTTLE in 1 CARTON (0078-0743-96) / .8 mL in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION/DROPS;OPHTHALMIC | Strength | 0.3% | ||||
Approval Date: | Oct 16, 2012 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Try a Trial | Patent Expiration: | Jun 8, 2024 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Try a Trial | Patent Expiration: | Mar 31, 2032 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Try a Trial | Patent Expiration: | Dec 1, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? |
Expired US Patents for NDA 203491
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Harrow Eye | ILEVRO | nepafenac | SUSPENSION/DROPS;OPHTHALMIC | 203491-001 | Oct 16, 2012 | ⤷ Try a Trial | ⤷ Try a Trial |
Harrow Eye | ILEVRO | nepafenac | SUSPENSION/DROPS;OPHTHALMIC | 203491-001 | Oct 16, 2012 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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