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Trifarotene - Generic Drug Details
» See Plans and Pricing
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-six 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: | 46 |
| US Patents: | 4 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 16 |
| Clinical Trials: | 3 |
| Patent Applications: | 36 |
| 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 | Get Started for $10 | Get Started for $10 | Y | Y | Get Started for $10 | ||
| Galderma Labs Lp | AKLIEF | trifarotene | CREAM;TOPICAL | 211527-001 | Oct 4, 2019 | RX | Yes | Yes | Get Started for $10 | Get Started for $10 | Y | Get Started for $10 | |||
| Galderma Labs Lp | AKLIEF | trifarotene | CREAM;TOPICAL | 211527-001 | Oct 4, 2019 | RX | Yes | Yes | Get Started for $10 | Get Started for $10 | Get Started for $10 | ||||
| >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 |
|---|---|---|
| South Africa | 200705930 | Get Started for $10 |
| Singapore | 11201408759X | Get Started for $10 |
| Japan | 6271527 | Get Started for $10 |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for trifarotene
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1831149 | 132020000000088 | Italy | Get Started for $10 | PRODUCT NAME: TRIFAROTENE, FACOLTATIVAMENTE NELLA FORMA DI UN SALE FARMACEUTICAMENTE ACCETTABILE(SELGAMIS); AUTHORISATION NUMBER(S) AND DATE(S): PL 10590/0071 - 0001, 20200113;047209010-022-034-046, 20200520 |
| 1831149 | 2090021-3 | Sweden | Get Started for $10 | 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 | LUC00162 | Luxembourg | Get Started for $10 | PRODUCT NAME: TRIFAROTENE, EVENTUELLEMENT SOUS LA FORME DE SEL PHARMACEUTIQUEMENT ACCEPTABLE; AUTHORISATION NUMBER AND DATE: EU/1/19/1420 20200217 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
