LIFITEGRAST - Generic Drug Details
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What are the generic sources for lifitegrast and what is the scope of patent protection?
Lifitegrast
is the generic ingredient in two branded drugs marketed by Eugia Pharma, Micro Labs, and Bausch And Lomb Inc, and is included in three 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.
Three suppliers are listed for this compound. There are two tentative approvals for this compound.
Summary for LIFITEGRAST
International Patents: | 154 |
US Patents: | 16 |
Tradenames: | 2 |
Applicants: | 3 |
NDAs: | 3 |
Finished Product Suppliers / Packagers: | 3 |
Raw Ingredient (Bulk) Api Vendors: | 46 |
Clinical Trials: | 18 |
Patent Applications: | 390 |
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 |
Generic filers with tentative approvals for LIFITEGRAST
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 5% | SOLUTION;OPHTHALMIC |
⤷ Sign Up | ⤷ Sign Up | 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
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
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 | ⤷ 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 | |||
Micro Labs | LIFITEGRAST | lifitegrast | SOLUTION/DROPS;OPHTHALMIC | 215081-001 | Aug 4, 2023 | AB | RX | No | No | ⤷ 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 | ⤷ 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 | ⤷ 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 | |
Bausch And Lomb Inc | XIIDRA | lifitegrast | SOLUTION/DROPS;OPHTHALMIC | 208073-001 | Jul 11, 2016 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ 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 LIFITEGRAST
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
New Zealand | 708821 | Lfa-1 inhibitor formulations | ⤷ Sign Up |
Japan | 2020023584 | ⤷ Sign Up | |
World Intellectual Property Organization (WIPO) | 2009128934 | ⤷ Sign Up | |
Denmark | 1881823 | ⤷ Sign Up | |
South Korea | 102157608 | ⤷ Sign Up | |
Canada | 2879982 | INHIBITEUR DE LFA-1 ET POLYMORPHE DE CELUI-CI (LFA-1 INHIBITOR AND POLYMORPH THEREOF) | ⤷ Sign Up |
Hong Kong | 1117083 | COMPOSITIONS AND METHODS FOR TREATMENT OF EYE DISORDERS | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for LIFITEGRAST
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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