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Last Updated: May 25, 2022

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-one patent family members in twenty-five countries.

The generic ingredient in XIIDRA is lifitegrast. Two suppliers are 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 is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

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 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
Bucci Laser Vision InstitutePhase 4
Aldeyra Therapeutics, Inc.Phase 2
University of WaterlooPhase 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 See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED)


Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Modulators of cellular adhesion
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Modulators of cellular adhesion
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED)

Modulators of cellular adhesion
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED)

Modulators of cellular adhesion
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Compositions and methods for treatment of eye disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Compositions and methods for treatment of eye disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED)

Crystalline pharmaceutical and methods of preparation and use thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED)

Compositions and methods for treatment of eye disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED)

Crystalline pharmaceutical and methods of preparation and use thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

LFA-1 inhibitor and methods of preparation and polymorph thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Modulators of cellular adhesion
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Crystalline pharmaceutical and methods of preparation and use thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Crystalline pharmaceutical and methods of preparation and use thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED)

Crystalline pharmaceutical and methods of preparation and use thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Novartis XIIDRA lifitegrast SOLUTION/DROPS;OPHTHALMIC 208073-001 Jul 11, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Novartis XIIDRA lifitegrast SOLUTION/DROPS;OPHTHALMIC 208073-001 Jul 11, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Novartis XIIDRA lifitegrast SOLUTION/DROPS;OPHTHALMIC 208073-001 Jul 11, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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: See Plans and Pricing

Canada

Patent: 02984
Estimated Expiration: See Plans and Pricing

Patent: 58665
Estimated Expiration: See Plans and Pricing

Patent: 05972
Estimated Expiration: See Plans and Pricing

China

Patent: 1873797
Estimated Expiration: See Plans and Pricing

Patent: 2056485
Estimated Expiration: See Plans and Pricing

Patent: 2065694
Estimated Expiration: See Plans and Pricing

Patent: 2065893
Estimated Expiration: See Plans and Pricing

Patent: 5943534
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 09371
Estimated Expiration: See Plans and Pricing

Patent: 65124
Estimated Expiration: See Plans and Pricing

Patent: 65125
Estimated Expiration: See Plans and Pricing

Patent: 76508
Estimated Expiration: See Plans and Pricing

Patent: 67886
Estimated Expiration: See Plans and Pricing

Patent: 32444
Estimated Expiration: See Plans and Pricing

Patent: 97775
Estimated Expiration: See Plans and Pricing

Japan

Patent: 08037
Estimated Expiration: See Plans and Pricing

Patent: 11500683
Estimated Expiration: See Plans and Pricing

Patent: 11516607
Estimated Expiration: See Plans and Pricing

Patent: 11518155
Estimated Expiration: See Plans and Pricing

Patent: 11521896
Estimated Expiration: See Plans and Pricing

Patent: 14132032
Estimated Expiration: See Plans and Pricing

Patent: 14132033
Estimated Expiration: See Plans and Pricing

Patent: 14133751
Estimated Expiration: See Plans and Pricing

Patent: 14221808
Estimated Expiration: See Plans and Pricing

Patent: 16128515
Estimated Expiration: See Plans and Pricing

Patent: 16153432
Estimated Expiration: See Plans and Pricing

Patent: 17141310
Estimated Expiration: See Plans and Pricing

Patent: 18127485
Estimated Expiration: See Plans and Pricing

Patent: 20023546
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 10004281
Estimated Expiration: See Plans and Pricing

Spain

Patent: 30406
Estimated Expiration: See Plans and Pricing

Patent: 63703
Estimated Expiration: See Plans and Pricing

Patent: 30024
Estimated Expiration: See Plans and Pricing

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
European Patent Office 3195861 COMPOSITIONS ET PROCÉDÉS DE TRAITEMENT DES TROUBLES DE LA SÈCHERESSE DE L' IL (COMPOSITIONS AND METHODS FOR TREATMENT OF DRY EYE DISORDERS) See Plans and Pricing
Spain 2530780 See Plans and Pricing
World Intellectual Property Organization (WIPO) 2009139817 See Plans and Pricing
South Korea 102157608 See Plans and Pricing
>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 See Plans and Pricing 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
Merck
Johnson and Johnson
Harvard Business School
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.