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Last Updated: May 31, 2023

XIIDRA Drug Patent Profile


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

Xiidra is a drug marketed by Novartis and is included in one NDA. There are sixteen patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and fifty-three patent family members in twenty-five countries.

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

DrugPatentWatch® Generic Entry Outlook for Xiidra

Xiidra was eligible for patent challenges on July 11, 2020.

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.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There are four tentative approvals for the generic drug (lifitegrast), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Drug patent expirations by year for XIIDRA
Drug Prices for XIIDRA

See drug prices for XIIDRA

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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
State University of New York College of OptometryPhase 4
Novartis PharmaceuticalsPhase 4
Bucci Laser Vision InstitutePhase 4

See all XIIDRA clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for XIIDRA
Paragraph IV (Patent) Challenges for XIIDRA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
XIIDRA Ophthalmic Solution lifitegrast 5% 208073 4 2020-07-13

US Patents and Regulatory Information for XIIDRA

XIIDRA is protected by sixteen US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of XIIDRA is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting XIIDRA

Modulators of cellular adhesion
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED)


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Modulators of cellular adhesion
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Modulators of cellular adhesion
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED)

Modulators of cellular adhesion
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED)

Modulators of cellular adhesion
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Compositions and methods for treatment of eye disorders
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Compositions and methods for treatment of eye disorders
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED)

Crystalline pharmaceutical and methods of preparation and use thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED)

Compositions and methods for treatment of eye disorders
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED)

Crystalline pharmaceutical and methods of preparation and use thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

LFA-1 inhibitor and methods of preparation and polymorph thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Modulators of cellular adhesion
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Crystalline pharmaceutical and methods of preparation and use thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Crystalline pharmaceutical and methods of preparation and use thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED)

Crystalline pharmaceutical and methods of preparation and use thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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

International Patents for XIIDRA

When does loss-of-exclusivity occur for XIIDRA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 08317473
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 02984
Estimated Expiration: ⤷  Try a Trial

Patent: 58665
Estimated Expiration: ⤷  Try a Trial

Patent: 05972
Estimated Expiration: ⤷  Try a Trial

China

Patent: 1873797
Estimated Expiration: ⤷  Try a Trial

Patent: 2056485
Estimated Expiration: ⤷  Try a Trial

Patent: 2065694
Estimated Expiration: ⤷  Try a Trial

Patent: 2065893
Estimated Expiration: ⤷  Try a Trial

Patent: 5943534
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 09371
Estimated Expiration: ⤷  Try a Trial

Patent: 65124
Estimated Expiration: ⤷  Try a Trial

Patent: 65125
Estimated Expiration: ⤷  Try a Trial

Patent: 76508
Estimated Expiration: ⤷  Try a Trial

Patent: 67886
Estimated Expiration: ⤷  Try a Trial

Patent: 32444
Estimated Expiration: ⤷  Try a Trial

Patent: 97775
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 08037
Estimated Expiration: ⤷  Try a Trial

Patent: 11500683
Estimated Expiration: ⤷  Try a Trial

Patent: 11516607
Estimated Expiration: ⤷  Try a Trial

Patent: 11518155
Estimated Expiration: ⤷  Try a Trial

Patent: 11521896
Estimated Expiration: ⤷  Try a Trial

Patent: 14132032
Estimated Expiration: ⤷  Try a Trial

Patent: 14132033
Estimated Expiration: ⤷  Try a Trial

Patent: 14133751
Estimated Expiration: ⤷  Try a Trial

Patent: 14221808
Estimated Expiration: ⤷  Try a Trial

Patent: 16128515
Estimated Expiration: ⤷  Try a Trial

Patent: 16153432
Estimated Expiration: ⤷  Try a Trial

Patent: 17141310
Estimated Expiration: ⤷  Try a Trial

Patent: 18127485
Estimated Expiration: ⤷  Try a Trial

Patent: 20023546
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 10004281
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 30406
Estimated Expiration: ⤷  Try a Trial

Patent: 63703
Estimated Expiration: ⤷  Try a Trial

Patent: 30024
Estimated Expiration: ⤷  Try a Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering XIIDRA around the world.

Country Patent Number Title Estimated Expiration
China 102056485 Topical LFA-1 antagonists for use in localized treatment of immune related disorders ⤷  Try a Trial
Hong Kong 1210145 抑制劑及其多晶型物 (LFA-1 INHIBITOR AND POLYMORPH THEREOF LFA-1) ⤷  Try a Trial
Portugal 1881823 ⤷  Try a Trial
Mexico 2010004281 COMPOSICIONES Y METODOS PARA EL TRATAMIENTO DE LA RETINOPATIA DIABETICA. (COMPOSITIONS AND METHODS FOR TREATMENT OF DIABETIC RETINOPATHY.) ⤷  Try a Trial
Spain 2830024 ⤷  Try a Trial
Australia 2008317473 Compositions and methods for treatment of diabetic retinopathy ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for XIIDRA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2444079 C02444079/01 Switzerland ⤷  Try a Trial PRODUCT NAME: LIFITEGRAST; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66850 19.12.2018
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Colorcon
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Johnson and Johnson
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Moodys

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 verification 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.