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XIIDRA Drug Profile

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Which patents cover Xiidra, and when can generic versions of Xiidra launch?

Xiidra is a drug marketed by Shire Dev Llc and is included in one NDA. There are fourteen patents protecting this drug.

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

Summary for XIIDRA

US Patents:	14
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	16
Patent Applications:	45
Drug Prices:	Drug price information for XIIDRA
DailyMed Link:	XIIDRA at DailyMed

Generic Entry Opportunity Date for XIIDRA

NDA:

208073

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.

Pharmacology for XIIDRA

Drug Class	Lymphocyte Function-Associated Antigen-1 Antagonist
Mechanism of Action	Lymphocyte Function-Associated Antigen-1 Antagonists

Synonyms for XIIDRA

(2S)-2-(((2-(Benzofuran-6-ylcarbonyl)-5,7-dichloro-1,2,3,4-tetrahydroisoquinolin-6- yl)carbonyl)amino)-3-(3-(methylsulfonyl)phenyl)propanoic acid

(2S)-2-[[2-(1-benzofuran-6-carbonyl)-5,7-dichloro3,4-dihydro-1H-isoquinoline-6-carbonyl]amino]-3-(3-methylsulfonylphenyl)propanoic acid

(S)-2-(2-(benzofuran-6-carbonyl)-5,7-dichloro-1,2,3,4-tetrahydroisoquinoline-6-carboxamido)-3-(3-(methylsulfonyl)phenyl)propanoic acid;(S)-2-(2-(benzofuran-6-carbonyl)-5,7-dichloro-1,2,3,4-tetrahydroisoquinoline-6-carboxamido

038E5L962W

1025967-78-5

1356856-75-1

915397-62-5

AKOS030628489

BDBM50386331

CHEBI:133023

CHEMBL2048028

compound 1g [PMID: 24900456]

CS-6264

D04ISS

D0Q9EV

D10374

DB11611

DTXSID60145345

Dual leukocytefunction-associated antigen-1/intracellular adhesion molecule-1 inhibitors (inflammatory diseases), SARcode

Dual LFA-1/ICAM-1 inhibitors (inflammatory diseases), SARcode

Dual LFA-1/ICAM-1 inhibitors, Sunesis

GTPL7533

HY-19344

L-Phenylalanine, N-((2-(6-benzofuranylcarbonyl)-5,7-dichloro-1,2,3,4-tetrahydro-6-isoquinolinyl)carbonyl)-3-(methylsulfonyl)-

Lifitegrast

Lifitegrast (USAN/INN)

Lifitegrast [USAN:INN]

MolPort-044-727-763

N-[2-(1-benzofuran-6-carbonyl)-5,7-dichloro-1,2,3,4-tetrahydroisoquinoline-6-carbonyl]-3-(methanesulfonyl)-L-phenylalanine

SAR 1118

SAR 1118-023

SAR-1118

SAR-1119

SAR1118

SCHEMBL2632068

SHP606

SPD606

UNII-038E5L962W

Xiidra (TN)

ZINC84668739

US Patents and Regulatory Information for XIIDRA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Shire Dev Llc	XIIDRA	lifitegrast	SOLUTION/DROPS;OPHTHALMIC	208073-001	Jul 11, 2016		RX	Yes	Yes
Shire Dev Llc	XIIDRA	lifitegrast	SOLUTION/DROPS;OPHTHALMIC	208073-001	Jul 11, 2016		RX	Yes	Yes			Y	Y
Shire Dev Llc	XIIDRA	lifitegrast	SOLUTION/DROPS;OPHTHALMIC	208073-001	Jul 11, 2016		RX	Yes	Yes
Shire Dev Llc	XIIDRA	lifitegrast	SOLUTION/DROPS;OPHTHALMIC	208073-001	Jul 11, 2016		RX	Yes	Yes			Y
Shire Dev Llc	XIIDRA	lifitegrast	SOLUTION/DROPS;OPHTHALMIC	208073-001	Jul 11, 2016		RX	Yes	Yes			Y	Y
Shire Dev Llc	XIIDRA	lifitegrast	SOLUTION/DROPS;OPHTHALMIC	208073-001	Jul 11, 2016		RX	Yes	Yes			Y

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Non-Orange Book US Patents for XIIDRA

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
8,378,105	Crystalline pharmaceutical and methods of preparation and use thereof
9,045,458	Compositions and methods for treatment
9,708,303	LFA-1 inhibitor and methods of preparation and polymorph thereof
7,989,626	Modulators of cellular adhesion
8,080,562	Crystalline pharmaceutical and methods of preparation and use thereof
8,758,776	Compositions and methods for treatment

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International Patents for XIIDRA

Country	Document Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2006125119
China	105820160
Japan	2014196353
Poland	2444079
Canada	2702984
China	1902195