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-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

Summary for XIIDRA

International Patents:	151
US Patents:	16
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	34
Clinical Trials:	10
Patent Applications:	61
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 Generic Entry Opportunity 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
Bucci Laser Vision Institute	Phase 4
Aldeyra Therapeutics, Inc.	Phase 2
University of Waterloo	Phase 4

See all XIIDRA clinical trials

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

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
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)
Spain	2530780
World Intellectual Property Organization (WIPO)	2009139817
South Korea	102157608

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