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Trifarotene - Generic Drug Details
What are the generic drug sources for trifarotene and what is the scope of freedom to operate?
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-four 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: | 44 |
| US Patents: | 4 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 9 |
| Clinical Trials: | 2 |
| 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 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 | Y | Y | 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 | 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 |
|---|---|---|
| Mexico | 354540 | Start Trial |
| Canada | 2590246 | Start Trial |
| Spain | 2380777 | Start Trial |
| European Patent Office | 2854802 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
