Arcutis Company Profile
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What is the competitive landscape for ARCUTIS
ARCUTIS has two approved drugs.
There are twenty US patents protecting ARCUTIS drugs.
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 | FOAM;TOPICAL | 217242-001 | Dec 15, 2023 | RX | Yes | Yes | 11,129,818 | ⤷ Start Trial | ⤷ Start Trial | ||||
| Arcutis | ZORYVE | roflumilast | FOAM;TOPICAL | 217242-001 | Dec 15, 2023 | RX | Yes | Yes | 12,005,052 | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Arcutis | ZORYVE | roflumilast | CREAM;TOPICAL | 215985-001 | Jul 29, 2022 | RX | Yes | Yes | 11,819,496 | ⤷ Start Trial | ⤷ Start Trial | ||||
| Arcutis | ZORYVE | roflumilast | CREAM;TOPICAL | 215985-001 | Jul 29, 2022 | RX | Yes | Yes | 12,005,051 | ⤷ Start Trial | ⤷ Start Trial | ||||
| Arcutis | ZORYVE | roflumilast | CREAM;TOPICAL | 215985-003 | Oct 4, 2025 | RX | Yes | Yes | 11,793,796 | ⤷ Start Trial | Y | ⤷ 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 Arcutis Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 2022547121 | ⤷ Start Trial |
| South Korea | 20230146513 | ⤷ Start Trial |
| European Patent Office | 4096630 | ⤷ Start Trial |
| Japan | 2018203736 | ⤷ Start Trial |
| European Patent Office | 4025214 | ⤷ Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for Arcutis Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1606261 | C 2010 014 | Romania | ⤷ Start 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 | 1090034-8 | Sweden | ⤷ Start Trial | PRODUCT NAME: ROFLUMILAST OCH SALTER DAERAV; REG. NO/DATE: EU/1/10/636/001 20100705 |
| 1606261 | C20100008 00033 | Estonia | ⤷ Start Trial | PRODUCT NAME: DAXAS-ROFLUMILAST; REG NO/DATE: K(2010)4785 05.07.2010 |
| 0706513 | 10C0052 | France | ⤷ Start Trial | PRODUCT NAME: ROFLUMILAST, ROFLUMILAST-N-OXYDE ET LES SELS DE CES COMPOSES; NAT. REGISTRATION NO/DATE: EU/1/16/636/001 20100705; FIRST REGISTRATION: EU/1/10/636/001 20100705 |
| 1606261 | PA2010010 | Lithuania | ⤷ Start 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 |

