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 Eugia Pharma, Ingenus Pharms Llc, Micro Labs, and Bausch And Lomb Inc, and is included in four 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 is one tentative approval for this compound.
Summary for lifitegrast
International Patents: | 154 |
US Patents: | 16 |
Tradenames: | 2 |
Applicants: | 4 |
NDAs: | 4 |
Finished Product Suppliers / Packagers: | 3 |
Raw Ingredient (Bulk) Api Vendors: | 46 |
Clinical Trials: | 18 |
Patent Applications: | 398 |
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 |
---|---|
State University of New York College of Optometry | Phase 4 |
Novartis Pharmaceuticals | 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/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 | 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 | 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 | ||
Micro Labs | LIFITEGRAST | lifitegrast | SOLUTION/DROPS;OPHTHALMIC | 215081-001 | Aug 4, 2023 | DISCN | 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 | Y | ⤷ Sign Up | |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for lifitegrast
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Bausch And Lomb Inc | XIIDRA | lifitegrast | SOLUTION/DROPS;OPHTHALMIC | 208073-001 | Jul 11, 2016 | ⤷ Sign Up | ⤷ Sign Up |
Bausch And Lomb Inc | XIIDRA | lifitegrast | SOLUTION/DROPS;OPHTHALMIC | 208073-001 | Jul 11, 2016 | ⤷ Sign Up | ⤷ Sign Up |
Bausch And Lomb Inc | XIIDRA | lifitegrast | SOLUTION/DROPS;OPHTHALMIC | 208073-001 | Jul 11, 2016 | ⤷ Sign Up | ⤷ Sign Up |
Bausch And Lomb Inc | XIIDRA | lifitegrast | SOLUTION/DROPS;OPHTHALMIC | 208073-001 | Jul 11, 2016 | ⤷ Sign Up | ⤷ Sign Up |
Bausch And Lomb Inc | XIIDRA | lifitegrast | SOLUTION/DROPS;OPHTHALMIC | 208073-001 | Jul 11, 2016 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent 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) | ⤷ Sign Up |
Spain | 2763703 | ⤷ Sign Up | |
Australia | 2019210525 | LFA-1 inhibitor and polymorph thereof | ⤷ Sign Up |
European Patent Office | 1682537 | MODULATORS OF CELLULAR ADHESION | ⤷ Sign Up |
European Patent Office | 3715345 | PROCÉDÉ DE PRÉPARATION D'UN INHIBITEUR DE LFA-1 ET POLYMORPHE ASSOCIÉ (PREPARATION OF LFA-1 INHIBITOR AND POLYMORPH THEREOF) | ⤷ Sign Up |
Canada | 2958665 | COMPOSITIONS ET PROCEDES POUR LE TRAITEMENT DE LA RETINOPATHIE DIABETIQUE (COMPOSITIONS AND METHODS FOR TREATMENT OF DIABETIC RETINOPATHY) | ⤷ 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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