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
Summary for XIIDRA
International Patents: | 153 |
US Patents: | 16 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 41 |
Clinical Trials: | 12 |
Patent Applications: | 70 |
Drug Prices: | Drug price information for XIIDRA |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for XIIDRA |
What excipients (inactive ingredients) are in XIIDRA? | XIIDRA excipients list |
DailyMed Link: | XIIDRA at DailyMed |


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
Sponsor | Phase |
---|---|
State University of New York College of Optometry | Phase 4 |
Novartis Pharmaceuticals | Phase 4 |
Bucci Laser Vision Institute | Phase 4 |
Pharmacology for XIIDRA
Drug Class | Lymphocyte Function-Associated Antigen-1 Antagonist |
Mechanism of Action | Lymphocyte Function-Associated Antigen-1 Antagonists |
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 |