Roflumilast Cream 0.15% — Competitive Intelligence Brief

Roflumilast Cream 0.15% (Roflumilast Cream 0.15%) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Phosphodiesterase 4 inhibitor. Area: Immunology.

phase 3 Phosphodiesterase 4 inhibitor Phosphodiesterase 4 Immunology Small molecule

Target snapshot

Roflumilast Cream 0.15% (Roflumilast Cream 0.15%) — Arcutis Biotherapeutics, Inc.. Roflumilast is a phosphodiesterase 4 inhibitor that reduces inflammation by blocking the action of phosphodiesterase 4.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Roflumilast Cream 0.15% TARGET	Roflumilast Cream 0.15%	Arcutis Biotherapeutics, Inc.	phase 3	Phosphodiesterase 4 inhibitor	Phosphodiesterase 4
Eucrisa	CRISABOROLE	Anacor Pharms Inc	marketed	Phosphodiesterase 4 Inhibitor [EPC]	Phosphodiesterase 4	2016-01-01
Eucrisa	Crisaborole	Anacor Pharms Inc	marketed	PDE-4 inhibitor	Phosphodiesterase 4 (PDE-4)	2016-01-01
Daliresp	ROFLUMILAST	Arcutis	marketed	Phosphodiesterase 4 Inhibitor [EPC]	cAMP-specific 3',5'-cyclic phosphodiesterase 4D	2011-01-01
Leustatin	CLADRIBINE		marketed	Purine Antimetabolite [EPC]	cAMP-specific 3',5'-cyclic phosphodiesterase 4A	1993-01-01
Ketas	IBUDILAST	Kyorin Pharmaceutical	marketed	ibudilast	cAMP-specific 3',5'-cyclic phosphodiesterase 4A	1989-01-01
Diphyllin	diprophylline		marketed	diprophylline	cAMP-specific 3',5'-cyclic phosphodiesterase 4B	1951-01-01

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

• 2038-11-23 — Leustatin · 10849919 · Method of Use · US
• 2041-09-10 — Leustatin · 12533408 · Method of Use · US
• 2041-09-10 — Leustatin · 12539329 · Method of Use · US

Sponsor landscape (Phosphodiesterase 4 inhibitor class)

1. Arcutis Biotherapeutics, Inc. · 1 drug in this class