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XIIDRA Drug Profile

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When do Xiidra patents expire, and what generic alternatives are available?

Xiidra is a drug marketed by Novartis and is included in one NDA. There are fifteen patents protecting this drug.

This drug has one hundred and four patent family members in twenty-one countries.

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

International Patents:	104
US Patents:	15
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	23
Clinical Trials:	4
Patent Applications:	51
Drug Prices:	Drug price information for XIIDRA
DailyMed Link:	XIIDRA at DailyMed

See drug prices for XIIDRA

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.

Recent Clinical Trials for XIIDRA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Bucci Laser Vision Institute	Phase 4
Weill Medical College of Cornell University	Phase 4
Shire Human Genetic Therapies, Inc.	Phase 4

See all XIIDRA clinical trials

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

038E5L962W

1025967-78-5

1356856-75-1

915397-62-5

AKOS030628489

BDBM50386331

CHEBI:133023

CHEMBL2048028

compound 1g [PMID: 24900456]

CS-6264

D10374

DB11611

DS-20052

DTXSID60145345

EX-A2582

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]

Lifitegrast; SAR 1118

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

SAR1118

SB18920

SCHEMBL2632068

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
Novartis	XIIDRA	lifitegrast	SOLUTION/DROPS;OPHTHALMIC	208073-001	Jul 11, 2016		RX	Yes	Yes			Y
Novartis	XIIDRA	lifitegrast	SOLUTION/DROPS;OPHTHALMIC	208073-001	Jul 11, 2016		RX	Yes	Yes			Y	Y
Novartis	XIIDRA	lifitegrast	SOLUTION/DROPS;OPHTHALMIC	208073-001	Jul 11, 2016		RX	Yes	Yes				Y
Novartis	XIIDRA	lifitegrast	SOLUTION/DROPS;OPHTHALMIC	208073-001	Jul 11, 2016		RX	Yes	Yes
Novartis	XIIDRA	lifitegrast	SOLUTION/DROPS;OPHTHALMIC	208073-001	Jul 11, 2016		RX	Yes	Yes			Y	Y
Novartis	XIIDRA	lifitegrast	SOLUTION/DROPS;OPHTHALMIC	208073-001	Jul 11, 2016		RX	Yes	Yes
Novartis	XIIDRA	lifitegrast	SOLUTION/DROPS;OPHTHALMIC	208073-001	Jul 11, 2016		RX	Yes	Yes

International Patents for XIIDRA

Country	Patent Number	Estimated Expiration
Japan	2016147908
Japan	2013010778
World Intellectual Property Organization (WIPO)	2009128933
China	101873797
China	102065694
Denmark	1881823
Mexico	2010004281