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Last Updated: May 29, 2024

Details for New Drug Application (NDA): 021862

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NDA 021862 describes NEVANAC, which is a drug marketed by Harrow Eye and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the NEVANAC profile page.

The generic ingredient in NEVANAC 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 021862
Applicant:Harrow Eye
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 021862
Generic Entry Date for 021862*:
Constraining patent/regulatory exclusivity:

*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: 021862
Mechanism of ActionCyclooxygenase Inhibitors
Suppliers and Packaging for NDA: 021862
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NEVANAC nepafenac SUSPENSION/DROPS;OPHTHALMIC 021862 NDA Novartis Pharmaceuticals Corporation 0078-0778 0078-0778-03 3 mL in 1 BOTTLE (0078-0778-03)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION/DROPS;OPHTHALMICStrength0.1%
Approval Date:Aug 19, 2005TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Jan 31, 2027Product Flag?Substance Flag?Delist Request?
Patent:⤷  Sign UpPatent Expiration:Dec 2, 2025Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Sign UpPatent Expiration:Dec 2, 2025Product Flag?YSubstance Flag?Delist Request?

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