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

Tradename:	NEVANAC
Applicant:	Harrow Eye
Ingredient:	nepafenac
Patents:	3

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 021862

Generic Entry Date for 021862^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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: 021862

Mechanism of Action	Cyclooxygenase 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:	RX	Dosage:	SUSPENSION/DROPS;OPHTHALMIC			Strength	0.1%
Approval Date:	Aug 19, 2005	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Jan 31, 2027	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	METHOD OF TREATING OCULAR INFLAMMATION
Patent:	⤷ Sign Up	Patent Expiration:	Dec 2, 2025	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Sign Up	Patent Expiration:	Dec 2, 2025	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 021862

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Harrow Eye	NEVANAC	nepafenac	SUSPENSION/DROPS;OPHTHALMIC	021862-001	Aug 19, 2005	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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