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 | 10,940,142 | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Arcutis | ZORYVE | roflumilast | CREAM;TOPICAL | 215985-001 | Jul 29, 2022 | 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 | 11,819,496 | ⤷ 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 | CREAM;TOPICAL | 215985-001 | Jul 29, 2022 | RX | Yes | Yes | 11,793,796 | ⤷ Try a Trial | Y | ⤷ 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 |
---|---|---|
Mexico | 2022009399 | ⤷ Try a Trial |
South Korea | 102607917 | ⤷ Try a Trial |
Japan | 2024016241 | ⤷ Try a Trial |
South Korea | 20220134617 | ⤷ Try a Trial |
Israel | 295172 | ⤷ 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 | PA2010010 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: ROFLUMILASTUM; REGISTRATION NO/DATE: EU/1/10/636/001-003 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 |
0706513 | 10C0052 | France | ⤷ Try a 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 | 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 |