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 thirteen US patents protecting ARCUTIS drugs.
There are forty-eight patent family members on ARCUTIS drugs in thirteen countries and nine supplementary protection certificates in eight countries.
Summary for Arcutis
| International Patents: | 48 |
| US Patents: | 13 |
| Tradenames: | 1 |
| Ingredients: | 1 |
| NDAs: | 2 |
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 | 215985-002 | Jul 9, 2024 | RX | Yes | Yes | 9,884,050 | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Arcutis | ZORYVE | roflumilast | FOAM;TOPICAL | 217242-001 | Dec 15, 2023 | RX | Yes | Yes | 12,005,052 | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Arcutis | ZORYVE | roflumilast | CREAM;TOPICAL | 215985-001 | Jul 29, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | |||||
| Arcutis | ZORYVE | roflumilast | CREAM;TOPICAL | 215985-001 | Jul 29, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | |||||
| Arcutis | ZORYVE | roflumilast | CREAM;TOPICAL | 215985-001 | Jul 29, 2022 | RX | Yes | Yes | 12,011,437 | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Arcutis | ZORYVE | roflumilast | CREAM;TOPICAL | 215985-001 | Jul 29, 2022 | RX | Yes | Yes | 11,992,480 | ⤷ Sign Up | ⤷ Sign Up | ||||
| Arcutis | ZORYVE | roflumilast | CREAM;TOPICAL | 215985-002 | Jul 9, 2024 | RX | Yes | Yes | 11,129,818 | ⤷ Sign Up | ⤷ 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 Arcutis Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Canada | 3162675 | ⤷ Sign Up |
| Canada | 3166300 | ⤷ Sign Up |
| World Intellectual Property Organization (WIPO) | 2021045804 | ⤷ Sign Up |
| South Korea | 20200016940 | ⤷ Sign Up |
| World Intellectual Property Organization (WIPO) | 2021155173 | ⤷ Sign Up |
| China | 116963717 | ⤷ Sign Up |
| Israel | 271028 | ⤷ Sign Up |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for Arcutis Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0706513 | 1090034-8 | Sweden | ⤷ Sign Up | PRODUCT NAME: ROFLUMILAST OCH SALTER DAERAV; REG. NO/DATE: EU/1/10/636/001 20100705 |
| 1606261 | C 2010 014 | Romania | ⤷ Sign Up | 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 |
| 1606261 | PA2010010 | Lithuania | ⤷ Sign Up | PRODUCT NAME: ROFLUMILASTUM; REGISTRATION NO/DATE: EU/1/10/636/001-003 20100705 |
| 0706513 | 10C0052 | France | ⤷ Sign Up | 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 | ⤷ Sign Up | 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 | C300462 | Netherlands | ⤷ Sign Up | 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 | C20100008 00033 | Estonia | ⤷ Sign Up | PRODUCT NAME: DAXAS-ROFLUMILAST; REG NO/DATE: K(2010)4785 05.07.2010 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
