Arcutis Company Profile
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What is the competitive landscape for ARCUTIS, and when can generic versions of ARCUTIS drugs launch?
ARCUTIS has two approved drugs.
There are seven US patents protecting ARCUTIS drugs.
There are forty-one patent family members on ARCUTIS drugs in twelve countries and nine supplementary protection certificates in eight countries.
Drugs and US Patents for Arcutis
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Arcutis | ZORYVE | roflumilast | CREAM;TOPICAL | 215985-001 | Jul 29, 2022 | RX | Yes | Yes | 9,884,050 | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Arcutis | ZORYVE | roflumilast | FOAM;TOPICAL | 217242-001 | Dec 15, 2023 | RX | Yes | Yes | 11,707,454 | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Arcutis | ZORYVE | roflumilast | FOAM;TOPICAL | 217242-001 | Dec 15, 2023 | RX | Yes | Yes | 11,129,818 | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Arcutis | ZORYVE | roflumilast | FOAM;TOPICAL | 217242-001 | Dec 15, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | |||||
Arcutis | ZORYVE | roflumilast | FOAM;TOPICAL | 217242-001 | Dec 15, 2023 | RX | Yes | Yes | 9,907,788 | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Arcutis | ZORYVE | roflumilast | CREAM;TOPICAL | 215985-001 | Jul 29, 2022 | RX | Yes | Yes | 11,129,818 | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Arcutis | ZORYVE | roflumilast | CREAM;TOPICAL | 215985-001 | Jul 29, 2022 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a 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 Arcutis Drugs
Country | Patent Number | Estimated Expiration |
---|---|---|
China | 116963717 | ⤷ Try a Trial |
South Korea | 20220134617 | ⤷ Try a Trial |
Israel | 271028 | ⤷ Try a Trial |
Japan | 6401884 | ⤷ Try a Trial |
Canada | 3006836 | ⤷ Try a Trial |
Israel | 295172 | ⤷ Try a Trial |
China | 115551478 | ⤷ Try a Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for Arcutis Drugs
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1606261 | C20100008 00033 | Estonia | ⤷ Try a Trial | PRODUCT NAME: DAXAS-ROFLUMILAST; REG NO/DATE: K(2010)4785 05.07.2010 |
0706513 | C300462 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: ROFLUMILAST, DESGEWENST IN DE VORM VAN HET N-OXIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/10/636/001-003 20100705 |
1606261 | C 2010 014 | Romania | ⤷ Try a Trial | PRODUCT NAME: ROFLUMILAST; NATIONAL AUTHORISATION NUMBER: RO EU/1/10/636/001, RO EU/1/10/636/002, RO EU/1/10/636/003; DATE OF NATIONAL AUTHORISATION: 20100705; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/10/636/001, EMEA EU/1/10/636/002, EMEA EU/1/10/636/003; DATE OF FIRST AUTHORISATION IN EEA: 20100705 |
0706513 | SPC/GB10/040 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: ROFLUMILAST, ROFLUMILAST-N-OXIDE AND THE SALTS OF THESE COMPOUNDS.; REGISTERED: UK EU/1/10/636/001 20100705; UK EU/1/10/636/002 20100705; UK EU/1/10/636/003 20100705 |
1606261 | PA2010010 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: ROFLUMILASTUM; REGISTRATION NO/DATE: EU/1/10/636/001-003 20100705 |
0706513 | 34/2010 | Austria | ⤷ Try a Trial | PRODUCT NAME: ROFLUMILAST UND DIE SALZE DIESER VERBINDUNG; REGISTRATION NO/DATE: EU/1/10/636/001 - EU/1/10/636/003 20100705 |
1606261 | PA2010010,C1606261 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: ROFLUMILASTUM; REGISTRATION NO/DATE: EU/1/10/636/001-003 20100705 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |