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Last Updated: July 18, 2024

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 Bausch And Lomb Inc 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-four patent family members in twenty-five countries.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Xiidra

A generic version of XIIDRA was approved as lifitegrast by MICRO LABS on August 4th, 2023.

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Drug patent expirations by year for XIIDRA
Drug Prices for XIIDRA

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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

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.

Patents protecting XIIDRA

Modulators of cellular adhesion
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Patented Use: TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED)


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Modulators of cellular adhesion
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Modulators of cellular adhesion
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Patented Use: TREATMENT OF SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED)

Modulators of cellular adhesion
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Patented Use: TREATMENT OF SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED)

Modulators of cellular adhesion
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Compositions and methods for treatment of eye disorders
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Compositions and methods for treatment of eye disorders
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Patented Use: TREATMENT OF SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED)

Crystalline pharmaceutical and methods of preparation and use thereof
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Patented Use: TREATMENT OF SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED)

Compositions and methods for treatment of eye disorders
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Patented Use: TREATMENT OF SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED)

Crystalline pharmaceutical and methods of preparation and use thereof
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LFA-1 inhibitor and methods of preparation and polymorph thereof
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Modulators of cellular adhesion
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Crystalline pharmaceutical and methods of preparation and use thereof
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Crystalline pharmaceutical and methods of preparation and use thereof
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Patented Use: TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED)

Crystalline pharmaceutical and methods of preparation and use thereof
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Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bausch And Lomb Inc XIIDRA lifitegrast SOLUTION/DROPS;OPHTHALMIC 208073-001 Jul 11, 2016 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Bausch And Lomb Inc XIIDRA lifitegrast SOLUTION/DROPS;OPHTHALMIC 208073-001 Jul 11, 2016 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bausch And Lomb Inc XIIDRA lifitegrast SOLUTION/DROPS;OPHTHALMIC 208073-001 Jul 11, 2016 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bausch And Lomb Inc XIIDRA lifitegrast SOLUTION/DROPS;OPHTHALMIC 208073-001 Jul 11, 2016 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
>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
Patent: Compositions and methods for treatment of diabetic retinopathy
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 02984
Patent: COMPOSITIONS ET PROCEDES POUR LE TRAITEMENT DE LA RETINOPATHIE DIABETIQUE (COMPOSITIONS AND METHODS FOR TREATMENT OF DIABETIC RETINOPATHY)
Estimated Expiration: ⤷  Sign Up

Patent: 58665
Patent: COMPOSITIONS ET PROCEDES POUR LE TRAITEMENT DE LA RETINOPATHIE DIABETIQUE (COMPOSITIONS AND METHODS FOR TREATMENT OF DIABETIC RETINOPATHY)
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Patent: 05972
Patent: COMPOSITIONS ET PROCEDES POUR LE TRAITEMENT DE LA RETINOPATHIE DIABETIQUE (COMPOSITIONS AND METHODS FOR TREATMENT OF DIABETIC RETINOPATHY)
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China

Patent: 1873797
Patent: Compositions and methods for treatment of diabetic retinopathy
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Patent: 2056485
Patent: Topical LFA-1 antagonists for use in localized treatment of immune related disorders
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Patent: 2065694
Patent: Aerosolized LFA-1 antagonists for use in localized treatment of immune related disorders
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Patent: 2065893
Patent: Delivery of LFA-1 antagonists to the gastrointestinal system
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Patent: 5943534
Patent: 用于局部治疗免疫相关疾病的局部LFA-1拮抗剂 (Topical LFA-1 antagonists for use in localized treatment of immune related disorders)
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European Patent Office

Patent: 09371
Patent: COMPOSITIONS ET PROCÉDÉS POUR LE TRAITEMENT DE LA RÉTINOPATHIE DIABÉTIQUE (COMPOSITIONS AND METHODS FOR TREATMENT OF DIABETIC RETINOPATHY)
Estimated Expiration: ⤷  Sign Up

Patent: 65124
Patent: ANTAGONISTES DE LFA-1 SOUS FORME D'AÉROSOL UTILISÉS EN TRAITEMENT LOCALISÉ DE TROUBLES DE NATURE IMMUNITAIRE (AEROSOLIZED LFA-1 ANTAGONISTS FOR USE IN LOCALIZED TREATMENT OF IMMUNE RELATED DISORDERS)
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Patent: 65125
Patent: ANTAGONISTES DE LFA-1 TOPIQUES UTILISÉS DANS LE TRAITEMENT LOCALISÉ DE TROUBLES DE NATURE IMMUNITAIRE (TOPICAL LFA-1 ANTAGONISTS FOR USE IN LOCALIZED TREATMENT OF IMMUNE RELATED DISORDERS)
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Patent: 76508
Patent: ADMINISTRATION D'ANTAGONISTES DE LFA-1 AU SYSTÈME GASTRO-INTESTINAL (DELIVERY OF LFA-1 ANTAGONISTS TO THE GASTROINTESTINAL SYSTEM)
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Patent: 67886
Patent: COMPOSITIONS ET PROCÉDÉS POUR LE TRAITEMENT DE L'OEDÈME MACULAIRE (COMPOSITIONS AND METHODS FOR TREATMENT OF MACULAR EDEMA)
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Patent: 32444
Patent: ANTAGONISTES LFA-1 TOPIQUES POUR UNE UTILISATION DANS LE TRAITEMENT LOCALISÉ DE TROUBLES IMMUNITAIRES ASSOCIÉS (TOPICAL LFA-1 ANTAGONISTS FOR USE IN LOCALIZED TREATMENT OF IMMUNE RELATED DISORDERS)
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Patent: 97775
Patent: COMPOSITIONS ET PROCÉDÉS POUR LE TRAITEMENT DE LA RÉTINOPATHIE DIABÉTIQUE (COMPOSITIONS AND METHODS FOR TREATMENT OF DIABETIC RETINOPATHY)
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Japan

Patent: 08037
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Patent: 11500683
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Patent: 11516607
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Patent: 11518155
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Patent: 11521896
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Patent: 14132032
Patent: TOPICAL LFA-1 ANTAGONISTS FOR USE IN LOCALIZED TREATMENT OF IMMUNE RELATED DISORDERS
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Patent: 14132033
Patent: AEROSOLIZED LFA-1 ANTAGONISTS FOR USE IN LOCALIZED TREATMENT OF IMMUNE RELATED DISORDERS
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Patent: 14133751
Patent: DELIVERY OF LFA-1 ANTAGONISTS TO GASTROINTESTINAL SYSTEM
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Patent: 14221808
Patent: 糖尿病性網膜症の治療のための組成物及び方法 (COMPOSITION AND METHOD FOR TREATMENT OF DIABETIC RETINOPATHY)
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Patent: 16128515
Patent: 免疫関連障害の局所治療に使用するためのエアゾール化LFA−1アンタゴニスト (AEROSOLIZED LFA-1 ANTAGONIST TO BE USED FOR TOPICAL TREATMENT OF IMMUNE RELATED DISORDERS)
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Patent: 16153432
Patent: 胃腸系へのLFA−1アンタゴニストの送達 (DELIVERY OF LFA-1 ANTAGONISTS TO GASTROINTESTINAL SYSTEM)
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Patent: 17141310
Patent: 免疫関連障害の局所治療に使用するためのエアゾール化LFA−1アンタゴニスト (AEROSOLIZED LFA-1 ANTAGONIST TO BE USED FOR TOPICAL TREATMENT OF IMMUNE RELATED DISORDERS)
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Patent: 18127485
Patent: 胃腸系へのLFA−1アンタゴニストの送達 (DELIVERY OF LFA-1 ANTAGONISTS TO GASTROINTESTINAL SYSTEM)
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Patent: 20023546
Patent: 胃腸系へのLFA−1アンタゴニストの送達 (DELIVERY OF LFA-1 ANTAGONISTS TO GASTROINTESTINAL SYSTEM)
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Mexico

Patent: 10004281
Patent: COMPOSICIONES Y METODOS PARA EL TRATAMIENTO DE LA RETINOPATIA DIABETICA. (COMPOSITIONS AND METHODS FOR TREATMENT OF DIABETIC RETINOPATHY.)
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Spain

Patent: 30406
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Patent: 63703
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Patent: 30024
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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
Australia 2019210525 LFA-1 inhibitor and polymorph thereof ⤷  Sign Up
Hungary E031979 ⤷  Sign Up
Japan 2011500683 ⤷  Sign Up
Japan 2013010778 MODULATOR OF CELLULAR ADHESION ⤷  Sign Up
>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 ⤷  Sign Up 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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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.