Details for New Drug Application (NDA): 208073

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NDA 208073 describes XIIDRA, which is a drug marketed by Bausch And Lomb Inc and is included in one NDA. It is available from two suppliers. There are sixteen patents protecting this drug. Additional details are available on the XIIDRA profile page.

The generic ingredient in XIIDRA is lifitegrast. Three suppliers are listed for this compound. Additional details are available on the lifitegrast profile page.

Summary for 208073

Tradename:	XIIDRA
Applicant:	Bausch And Lomb Inc
Ingredient:	lifitegrast
Patents:	16

Pharmacology for NDA: 208073

Mechanism of Action	Lymphocyte Function-Associated Antigen-1 Antagonists

Suppliers and Packaging for NDA: 208073

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
XIIDRA	lifitegrast	SOLUTION/DROPS;OPHTHALMIC	208073	NDA	Novartis Pharmaceuticals Corporation	0078-0911	0078-0911-12	12 POUCH in 1 CARTON (0078-0911-12) / 5 AMPULE in 1 POUCH (0078-0911-05) / .2 mL in 1 AMPULE
XIIDRA	lifitegrast	SOLUTION/DROPS;OPHTHALMIC	208073	NDA	Novartis Pharmaceuticals Corporation	0078-0911	0078-0911-94	4 POUCH in 1 CARTON (0078-0911-94) / 5 AMPULE in 1 POUCH (0078-0911-95) / .2 mL in 1 AMPULE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	5%
Approval Date:	Jul 11, 2016	TE:	AB	RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Nov 5, 2024	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED)
Patent:	⤷ Sign Up	Patent Expiration:	Dec 18, 2033	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Sign Up	Patent Expiration:	Mar 10, 2025	Product Flag?	Y	Substance Flag?	Y	Delist Request?

Expired US Patents for NDA 208073

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch And Lomb Inc	XIIDRA	lifitegrast	SOLUTION/DROPS;OPHTHALMIC	208073-001	Jul 11, 2016	⤷ Sign Up	⤷ Sign Up
Bausch And Lomb Inc	XIIDRA	lifitegrast	SOLUTION/DROPS;OPHTHALMIC	208073-001	Jul 11, 2016	⤷ Sign Up	⤷ Sign Up
Bausch And Lomb Inc	XIIDRA	lifitegrast	SOLUTION/DROPS;OPHTHALMIC	208073-001	Jul 11, 2016	⤷ Sign Up	⤷ Sign Up
Bausch And Lomb Inc	XIIDRA	lifitegrast	SOLUTION/DROPS;OPHTHALMIC	208073-001	Jul 11, 2016	⤷ Sign Up	⤷ Sign Up
Bausch And Lomb Inc	XIIDRA	lifitegrast	SOLUTION/DROPS;OPHTHALMIC	208073-001	Jul 11, 2016	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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