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Last Updated: October 2, 2023

Lifitegrast - Generic Drug Details

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What are the generic drug sources for lifitegrast and what is the scope of freedom to operate?

Lifitegrast is the generic ingredient in two branded drugs marketed by Micro Labs and Novartis, and is included in two NDAs. There are sixteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Lifitegrast has one hundred and fifty-four patent family members in twenty-five countries.

One supplier is listed for this compound. There are three tentative approvals for this compound.

Summary for lifitegrast

International Patents:	154
US Patents:	16
Tradenames:	2
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	43
Clinical Trials:	18
Patent Applications:	88
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for lifitegrast
What excipients (inactive ingredients) are in lifitegrast?	lifitegrast excipients list
DailyMed Link:	lifitegrast at DailyMed

Recent Clinical Trials for lifitegrast

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Novartis Pharmaceuticals	Phase 4
State University of New York College of Optometry	Phase 4
University of Waterloo	Phase 4

See all lifitegrast clinical trials

Generic filers with tentative approvals for LIFITEGRAST

Applicant	Application No.	Strength	Dosage Form
⤷ Try a Trial	⤷ Try a Trial	5%	SOLUTION;OPHTHALMIC
⤷ Try a Trial	⤷ Try a Trial	5%	SOLUTION/DROPS;OPHTHALMIC
⤷ Try a Trial	⤷ Try a Trial	5%	SOLUTION/DROPS;OPHTHALMIC

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for lifitegrast

Drug Class	Lymphocyte Function-Associated Antigen-1 Antagonist
Mechanism of Action	Lymphocyte Function-Associated Antigen-1 Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for lifitegrast

S01XA	Other ophthalmologicals
S01X	OTHER OPHTHALMOLOGICALS
S01	OPHTHALMOLOGICALS
S	Sensory organs

Paragraph IV (Patent) Challenges for LIFITEGRAST

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
XIIDRA	Ophthalmic Solution	lifitegrast	5%	208073	4	2020-07-13

US Patents and Regulatory Information for lifitegrast

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Glossary

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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
Novartis	XIIDRA	lifitegrast	SOLUTION/DROPS;OPHTHALMIC	208073-001	Jul 11, 2016	AT	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Novartis	XIIDRA	lifitegrast	SOLUTION/DROPS;OPHTHALMIC	208073-001	Jul 11, 2016	AT	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial		Y		⤷ Try a Trial
Novartis	XIIDRA	lifitegrast	SOLUTION/DROPS;OPHTHALMIC	208073-001	Jul 11, 2016	AT	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	AT	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	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 lifitegrast

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Country	Patent Number	Title	Estimated Expiration
Canada	2958665	COMPOSITIONS ET PROCEDES POUR LE TRAITEMENT DE LA RETINOPATHIE DIABETIQUE (COMPOSITIONS AND METHODS FOR TREATMENT OF DIABETIC RETINOPATHY)	⤷ Try a Trial
Japan	2019081785	眼障害の治療のための組成物および方法 (COMPOSITIONS AND METHODS FOR TREATMENT OF EYE DISORDERS)	⤷ Try a Trial
European Patent Office	2934510	FORMULATIONS D'INHIBITEUR DE LFA-1 (LFA-1 INHIBITOR FORMULATIONS)	⤷ Try a Trial
Spain	2614080		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for lifitegrast

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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

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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.