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Trifarotene - Generic Drug Details
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What are the generic drug sources for trifarotene and what is the scope of patent protection?
Trifarotene
is the generic ingredient in one branded drug marketed by Galderma Labs Lp and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.Trifarotene has forty-five patent family members in twenty-five countries.
There is one drug master file entry for trifarotene. One supplier is listed for this compound.
Summary for trifarotene
| International Patents: | 45 |
| US Patents: | 4 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 9 |
| Clinical Trials: | 3 |
| Patent Applications: | 19 |
| DailyMed Link: | trifarotene at DailyMed |
Recent Clinical Trials for trifarotene
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Galderma R&D | Phase 4 |
| Galderma R&D | Phase 3 |
| Mayne Pharma International Pty Ltd | Phase 2 |
US Patents and Regulatory Information for trifarotene
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Galderma Labs Lp | AKLIEF | trifarotene | CREAM;TOPICAL | 211527-001 | Oct 4, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Galderma Labs Lp | AKLIEF | trifarotene | CREAM;TOPICAL | 211527-001 | Oct 4, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Galderma Labs Lp | AKLIEF | trifarotene | CREAM;TOPICAL | 211527-001 | Oct 4, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Galderma Labs Lp | AKLIEF | trifarotene | CREAM;TOPICAL | 211527-001 | Oct 4, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Galderma Labs Lp | AKLIEF | trifarotene | CREAM;TOPICAL | 211527-001 | Oct 4, 2019 | 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 trifarotene
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Canada | 2874474 | Start Trial |
| Hong Kong | 1204975 | Start Trial |
| Denmark | 1831149 | Start Trial |
| South Africa | 200705930 | Start Trial |
| France | 2991177 | Start Trial |
| Australia | 2013269583 | Start Trial |
| Brazil | 112014029885 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for trifarotene
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1831149 | 301042 | Netherlands | Start Trial | PRODUCT NAME: TRIFAROTEEN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; NATIONAL REGISTRATION NO/DATE: RVG 124058 20200310; FIRST REGISTRATION: GB PL 10590/0071 20200113 |
| 1831149 | CA 2020 00027 | Denmark | Start Trial | PRODUCT NAME: TRIFAROTEN, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT DERAF; NAT. REG. NO/DATE: 61878 20200120; FIRST REG. NO/DATE: UK PL 10590/0071 20200113 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
