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Trifarotene - Generic Drug Details
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 five patents protecting this compound. Additional information is available in the individual branded drug profile pages.Trifarotene has fifty-seven patent family members in twenty-six countries.
There is one drug master file entry for trifarotene. One supplier is listed for this compound.
Summary for trifarotene
| International Patents: | 57 |
| US Patents: | 5 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 22 |
| Clinical Trials: | 4 |
| Patent Applications: | 57 |
| What excipients (inactive ingredients) are in trifarotene? | trifarotene excipients list |
| 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 | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | ||||
| Galderma Labs Lp | AKLIEF | trifarotene | CREAM;TOPICAL | 211527-001 | Oct 4, 2019 | RX | Yes | Yes | ⤷ Try it Free | ⤷ Try it Free | Y | ⤷ Try it Free | |||
| Galderma Labs Lp | AKLIEF | trifarotene | CREAM;TOPICAL | 211527-001 | Oct 4, 2019 | RX | Yes | Yes | ⤷ Try it Free | ⤷ Try it Free | Y | ⤷ Try it Free | |||
| >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 |
|---|---|---|
| France | 2991176 | ⤷ Try it Free |
| Spain | 2691299 | ⤷ Try it Free |
| Russian Federation | 2014152977 | ⤷ Try it Free |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for trifarotene
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1831149 | 122020000029 | Germany | ⤷ Try it Free | PRODUCT NAME: TRIFAROTEN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE VON TRIFAROTEN; NAT. REGISTRATION NO/DATE: 2203224.00.00 20200415; FIRST REGISTRATION: GB PL 10590/0071 - 0001 20200113 |
| 1831149 | 2090021-3 | Sweden | ⤷ Try it Free | PRODUCT NAME: TRIFAROTENE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; NAT. REG. NO/DATE: MT NR:58467 20200131; FIRST REG.: GB PL 10590/0071 20200113 |
| 1831149 | 2020/023 | Ireland | ⤷ Try it Free | PRODUCT NAME: TRIFAROTENE, OPTIONALLY IN THE FORM OF APHARMACEUTICALLY ACCEPTABLE SALT; NAT REGISTRATION NO/DATE: PA0590/031/001 20200221; FIRST REGISTRATION NO/DATE: PL 10590/0071-0001 13/01/2020 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
