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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 one branded drug marketed by Novartis and is included in one NDA. There are fifteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.Lifitegrast has one hundred and twenty patent family members in twenty-one countries.
Two suppliers are listed for this compound.
Summary for lifitegrast
International Patents: | 120 |
US Patents: | 15 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Suppliers / Packagers: | 2 |
Bulk Api Vendors: | 30 |
Clinical Trials: | 16 |
Patent Applications: | 349 |
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 |
---|---|
Richard W Yee, MD | Early Phase 1 |
Novartis | Early Phase 1 |
Research Insight LLC | Phase 4 |
Pharmacology for lifitegrast
Drug Class | Lymphocyte Function-Associated Antigen-1 Antagonist |
Mechanism of Action | Lymphocyte Function-Associated Antigen-1 Antagonists |
Paragraph IV (Patent) Challenges for LIFITEGRAST
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
XIIDRA | SOLUTION/DROPS;OPHTHALMIC | lifitegrast | 208073 | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Novartis | XIIDRA | lifitegrast | SOLUTION/DROPS;OPHTHALMIC | 208073-001 | Jul 11, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
Novartis | XIIDRA | lifitegrast | SOLUTION/DROPS;OPHTHALMIC | 208073-001 | Jul 11, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
Novartis | XIIDRA | lifitegrast | SOLUTION/DROPS;OPHTHALMIC | 208073-001 | Jul 11, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
Novartis | XIIDRA | lifitegrast | SOLUTION/DROPS;OPHTHALMIC | 208073-001 | Jul 11, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
Novartis | XIIDRA | lifitegrast | SOLUTION/DROPS;OPHTHALMIC | 208073-001 | Jul 11, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
Novartis | XIIDRA | lifitegrast | SOLUTION/DROPS;OPHTHALMIC | 208073-001 | Jul 11, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start 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
Country | Patent Number | Estimated Expiration |
---|---|---|
Hong Kong | 1210782 | Start Trial |
European Patent Office | 1682537 | Start Trial |
Hong Kong | 1095815 | Start Trial |
Poland | 1682537 | Start Trial |
World Intellectual Property Organization (WIPO) | 2006125119 | Start Trial |
Japan | 2020023584 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for lifitegrast
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2444079 | C02444079/01 | Switzerland | Start 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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