Details for Patent: 12,016,848

Which drugs does patent 12,016,848 protect, and when does it expire?

Patent 12,016,848 protects ZORYVE and is included in two NDAs.

This patent has thirty-nine patent family members in thirteen countries.

Summary for Patent: 12,016,848

Title:	Roflumilast formulations with an improved pharmacokinetic profile
Abstract:	An improved a method of treating a patient having a disorder responsive to PDE-4 inhibition by administering roflumilast. The improvement involves administering the roflumilast topically in a composition having a roflumilast release profile that produces in the patient a flattened plasma concentration time curve and a reduced Cmax relative to oral administration of a PDE4-inhibiting amount of roflumilast. Such disorders include inflammatory disorders such as inflammatory dermatoses, including psoriasis, atopic dermatitis and seborrheic dermatitis. Such disorders also include inflammatory diseases in a variety of organs, especially the lungs (asthma, COPD). Because of reduced side effects with topical administration due to the improved pharmacokinetics (PK) characteristics, it may be possible to provide higher systemic exposures (AUCs) with topical administration, resulting in greater therapeutic efficacy than with the oral route of administration.
Inventor(s):	David Osborne
Assignee:	Arcutis Biotherapeutics Inc
Application Number:	US18/453,674
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 12,016,848
Patent Claim Types: see list of patent claims	Composition; Dosage form;

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Recent additions to Drugs Protected by US Patent 12,016,848

These patents are from the daily update and have not yet been integrated into the regular database

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Type	RLD	Patent No.	Product	Substance	Delist Req.	Patent Expiration	Usecode	Patented / Exclusive Use
Arcutis	ZORYVE	roflumilast	FOAM	217242	Dec 15, 2023	RX	Yes	12,016,848	Y
Arcutis	ZORYVE	roflumilast	CREAM	215985	Jul 9, 2024	RX	Yes	12,016,848	Y
Arcutis	ZORYVE	roflumilast	CREAM	215985	Jul 29, 2022	RX	Yes	12,016,848	Y
Arcutis	ZORYVE	roflumilast	CREAM	215985	Oct 4, 2025	RX	Yes	12,016,848	Y

Drugs Protected by US Patent 12,016,848

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Arcutis	ZORYVE	roflumilast	CREAM;TOPICAL	215985-002	Jul 9, 2024		RX	Yes	Yes	12,016,848		Y
Arcutis	ZORYVE	roflumilast	CREAM;TOPICAL	215985-001	Jul 29, 2022		RX	Yes	Yes	12,016,848		Y
Arcutis	ZORYVE	roflumilast	CREAM;TOPICAL	215985-003	Oct 4, 2025		RX	Yes	Yes	12,016,848		Y
Arcutis	ZORYVE	roflumilast	FOAM;TOPICAL	217242-001	Dec 15, 2023		RX	Yes	Yes	12,016,848		Y

International Family Members for US Patent 12,016,848

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2018282098
Australia	2021214399
Brazil	112019025748
Brazil	112022015104