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Generated: September 18, 2018

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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.

Drug patent expirations by year for XIIDRA
Generic Entry Opportunity Date for XIIDRA
Generic Entry Date for XIIDRA*:
Constraining patent/regulatory exclusivity:
NDA:
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.

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

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

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Serving hundreds of leading biopharmaceutical companies globally:

UBS
Accenture
Citi
Farmers Insurance
Colorcon
Argus Health
Express Scripts
McKinsey
Daiichi Sankyo

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.