XIIDRA Drug Patent Profile

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

See drug prices for XIIDRA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for XIIDRA

NDA:

208073

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

See all XIIDRA clinical trials

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

S01XA	Other ophthalmologicals
S01X	OTHER OPHTHALMOLOGICALS
S01	OPHTHALMOLOGICALS
S	Sensory organs

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.

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

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

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

Canada

China

European Patent Office

Japan

Mexico

Spain

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
Hong Kong	1210145	抑制劑及其多晶型物 (LFA-1 INHIBITOR AND POLYMORPH THEREOF LFA-1)
Portugal	1881823
Mexico	2010004281	COMPOSICIONES Y METODOS PARA EL TRATAMIENTO DE LA RETINOPATIA DIABETICA. (COMPOSITIONS AND METHODS FOR TREATMENT OF DIABETIC RETINOPATHY.)
Spain	2830024
Australia	2008317473	Compositions and methods for treatment of diabetic retinopathy

Supplementary Protection Certificates for XIIDRA

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