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 sixteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.Lifitegrast has one hundred and fifty-two patent family members in twenty-five countries.
Two suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for lifitegrast
International Patents: | 152 |
US Patents: | 16 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 34 |
Clinical Trials: | 16 |
Patent Applications: | 76 |
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 |
---|---|
University of Waterloo | Phase 4 |
Research Insight LLC | Phase 4 |
Novartis | Early Phase 1 |
Generic filers with tentative approvals for LIFITEGRAST
Applicant | Application No. | Strength | Dosage Form |
See Plans and Pricing | See Plans and Pricing | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Novartis | XIIDRA | lifitegrast | SOLUTION/DROPS;OPHTHALMIC | 208073-001 | Jul 11, 2016 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Novartis | XIIDRA | lifitegrast | SOLUTION/DROPS;OPHTHALMIC | 208073-001 | Jul 11, 2016 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Novartis | XIIDRA | lifitegrast | SOLUTION/DROPS;OPHTHALMIC | 208073-001 | Jul 11, 2016 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | Y | See Plans and Pricing | ||
Novartis | XIIDRA | lifitegrast | SOLUTION/DROPS;OPHTHALMIC | 208073-001 | Jul 11, 2016 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | Y | See Plans and Pricing | ||
Novartis | XIIDRA | lifitegrast | SOLUTION/DROPS;OPHTHALMIC | 208073-001 | Jul 11, 2016 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
>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 |
---|---|---|---|
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) | See Plans and Pricing |
Cyprus | 1116045 | See Plans and Pricing | |
Denmark | 1682537 | See Plans and Pricing | |
Canada | 2879982 | INHIBITEUR DE LFA-1 ET POLYMORPHE DE CELUI-CI (LFA-1 INHIBITOR AND POLYMORPH THEREOF) | See Plans and Pricing |
China | 102056485 | Topical LFA-1 antagonists for use in localized treatment of immune related disorders | See Plans and Pricing |
>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 | See Plans and Pricing | 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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