Trifarotene - Generic Drug Details
✉ Email this page to a colleague
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 sixty patent family members in twenty-eight countries.
There is one drug master file entry for trifarotene. One supplier is listed for this compound.
Summary for trifarotene
International Patents: | 60 |
US Patents: | 5 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Drug Master File Entries: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 33 |
Clinical Trials: | 10 |
Patent Applications: | 89 |
What excipients (inactive ingredients) are in trifarotene? | trifarotene excipients list |
DailyMed Link: | trifarotene at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for trifarotene
Generic Entry Date for trifarotene*:
Constraining patent/regulatory exclusivity:
Dosage:
CREAM;TOPICAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for trifarotene
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Taro Pharmaceuticals USA | Phase 1 |
Teva Pharmaceuticals USA | Phase 3 |
Teva Pharmaceuticals, Inc. | Phase 3 |
Pharmacology for trifarotene
Drug Class | Retinoid |
Anatomical Therapeutic Chemical (ATC) Classes for trifarotene
Paragraph IV (Patent) Challenges for TRIFAROTENE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
AKLIEF | Cream | trifarotene | 0.005% | 211527 | 2 | 2023-10-04 |
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Galderma Labs Lp | AKLIEF | trifarotene | CREAM;TOPICAL | 211527-001 | Oct 4, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Galderma Labs Lp | AKLIEF | trifarotene | CREAM;TOPICAL | 211527-001 | Oct 4, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Galderma Labs Lp | AKLIEF | trifarotene | CREAM;TOPICAL | 211527-001 | Oct 4, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Galderma Labs Lp | AKLIEF | trifarotene | CREAM;TOPICAL | 211527-001 | Oct 4, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Galderma Labs Lp | AKLIEF | trifarotene | CREAM;TOPICAL | 211527-001 | Oct 4, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
>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 | Title | Estimated Expiration |
---|---|---|---|
Australia | 2013269582 | Topical compositions in the form of a gel containing a particular solubilised retinoid | ⤷ Sign Up |
France | 2991176 | COMPOSITIONS TOPIQUES, CONTENANT UN RETINOIDE SOLUBILISE, DE TYPE GEL HYDROGLYCOLIQUE | ⤷ Sign Up |
World Intellectual Property Organization (WIPO) | 2013178760 | ⤷ Sign Up | |
France | 2991177 | COMPOSITIONS TOPIQUES, CONTENANT UN RETINOIDE, DE TYPE EMULSION HUILE DANS EAU SANS EMULSIONNANT | ⤷ Sign Up |
China | 104507471 | Topical compositions in the form of a gel containing a particular solubilised retinoid | ⤷ Sign Up |
South Korea | 20070087626 | NOVEL LIGANDS THAT MODULATE RAR RECEPTORS, AND USE THEREOF IN HUMAN MEDICINE AND IN COSMETICS | ⤷ Sign Up |
World Intellectual Property Organization (WIPO) | 2006066978 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for trifarotene
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1831149 | 132020000000088 | Italy | ⤷ Sign Up | 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 | CA 2020 00027 | Denmark | ⤷ Sign Up | 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 |
1831149 | C202030025 | Spain | ⤷ Sign Up | PRODUCT NAME: TRIFAROTENO, OPCIONALMENT EN FORMA DE UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: 85017-SE/H/1863/001/DC; DATE OF AUTHORISATION: 20200417; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): PL 10590/0071 -0001; DATE OF FIRST AUTHORISATION IN EEA: 20200113 |
1831149 | 122020000029 | Germany | ⤷ Sign Up | 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 | PA2022002,C1831149 | Lithuania | ⤷ Sign Up | PRODUCT NAME: TRIFAROTENAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS FORMOS ; REGISTRATION NO/DATE: UK, PL 10590/0071 20200113 |
1831149 | PA2022002 | Lithuania | ⤷ Sign Up | PRODUCT NAME: TRIFAROTENAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS FORMOS ; REGISTRATION NO/DATE: PL 10590/0071 20200113 |
1831149 | C 2022 002 | Romania | ⤷ Sign Up | PRODUCT NAME: TRIFAROTEN, OPTIONAL SUB FORMA UNEI SARI ACCEPTABILE DIN PUNCT DE VEDERE FARMACEUTIC; NATIONAL AUTHORISATION NUMBER: 14177/2021//01-02-03-04; DATE OF NATIONAL AUTHORISATION: 20211124; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): UK. PL 10590/0071; DATE OF FIRST AUTHORISATION IN EEA: 20200113 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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.