Arcutis Company Profile
What is the competitive landscape for ARCUTIS
ARCUTIS has two approved drugs.
There are twenty-two 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 | CREAM;TOPICAL | 215985-001 | Jul 29, 2022 | RX | Yes | Yes | 11,793,796 | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Arcutis | ZORYVE | roflumilast | CREAM;TOPICAL | 215985-003 | Oct 4, 2025 | RX | Yes | Yes | 10,940,142 | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Arcutis | ZORYVE | roflumilast | CREAM;TOPICAL | 215985-003 | Oct 4, 2025 | RX | Yes | Yes | 12,005,051 | ⤷ 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 Arcutis Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 7386353 | ⤷ Start Trial |
| Canada | 3006836 | ⤷ Start Trial |
| Japan | 2018203769 | ⤷ Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for Arcutis Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 |
| 0706513 | SPC/GB10/040 | United Kingdom | ⤷ Start 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 | ⤷ 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 |

