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Last Updated: February 20, 2020

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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 six 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.

US ANDA Litigation and Generic Entry Outlook for Xiidra

Xiidra will be eligible for patent challenges on July 11, 2020. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 15, 2029. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for XIIDRA
Drug patent expirations by year for XIIDRA
Drug Prices for XIIDRA

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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.

Recent Clinical Trials for XIIDRA

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

SponsorPhase
Sun Pharmaceutical Industries LimitedPhase 4
Toyos ClinicPhase 4
Bucci Laser Vision InstitutePhase 4

See all XIIDRA clinical trials

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