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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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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.
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