Orange Book product · Brand (NDA)

ZORYVE

ROFLUMILAST

Brand (NDA)NDA 215985RX ARCUTIS

View ROFLUMILAST family Open on FDA Orange Book

At a glance

Jul 29, 2022

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Key dates

Approval
FDA approval date of this drug product.
Jul 29, 2022
3 yr 11 mo ago
Today
Exclusivity ends · NPP
New patient population exclusivity (3 years)
Oct 05, 2026
in 4 mo
Patent 10940142 expires
Listed drug product patent expiration.
Jun 07, 2037
in 11 yr 2 mo
Patent 11793796 expires
Listed drug product patent expiration.
Jun 07, 2037
in 11 yr 2 mo
Patent 11819496 expires
Listed method-of-use patent (U-3748) expiration.
Jun 07, 2037
in 11 yr 2 mo
Patent 11992480 expires
Listed method-of-use patent (U-3748) expiration.
Jun 07, 2037
in 11 yr 2 mo
Patent 12005051 expires
Listed method-of-use patent (U-3748) expiration.
Jun 07, 2037
in 11 yr 2 mo
Patent 12005052 expires
Listed drug product patent expiration.
Jun 07, 2037
in 11 yr 2 mo
Patent 12011437 expires
Listed drug product patent expiration.
Jun 07, 2037
in 11 yr 2 mo
Patent 12016848 expires
Listed drug product patent expiration.
Jun 07, 2037
in 11 yr 2 mo
Patent 12042487 expires
Listed drug product patent expiration.
Jun 07, 2037
in 11 yr 2 mo
Patent 12220409 expires
Listed drug product patent expiration.
Jun 07, 2037
in 11 yr 2 mo
Patent 12257242 expires
Listed drug product patent expiration.
Jun 07, 2037
in 11 yr 2 mo
Patent 12310956 expires
Listed method-of-use patent (U-3748) expiration.
Jun 07, 2037
in 11 yr 2 mo
Patent 12336983 expires
Listed drug product patent expiration.
Jun 07, 2037
in 11 yr 2 mo
Patent 9884050 expires
Listed drug product patent expiration.
Jun 07, 2037
in 11 yr 2 mo
Patent 9907788 expires
Listed method-of-use patent (U-3712) expiration.
Jun 07, 2037
in 11 yr 2 mo
Patent 9907788 expires
Listed method-of-use patent (U-3408) expiration.
Jun 07, 2037
in 11 yr 2 mo
Patent 11129818 expires
Listed method-of-use patent (U-3712) expiration.
Aug 25, 2037
in 11 yr 4 mo
Patent 11129818 expires
Listed method-of-use patent (U-3408) expiration.
Aug 25, 2037
in 11 yr 4 mo

Pharmaceutical detail

Active ingredient

ROFLUMILAST

Strength

0.3%

Dosage form

CREAM

Route

TOPICAL

TE code

Not listed

Application

NDA 215985

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Marketing exclusivity (1)

NPPNew patient population exclusivity (3 years)
Oct 05, 2026
in 4 mo

Listed patents (18)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
10940142	Jun 07, 2037	in 11 yr 2 mo	Product
11793796	Jun 07, 2037	in 11 yr 2 mo	Product
11819496	Jun 07, 2037	in 11 yr 2 mo	U-3748
11992480	Jun 07, 2037	in 11 yr 2 mo	U-3748
12005051	Jun 07, 2037	in 11 yr 2 mo	U-3748
12005052	Jun 07, 2037	in 11 yr 2 mo	Product
12011437	Jun 07, 2037	in 11 yr 2 mo	Product
12016848	Jun 07, 2037	in 11 yr 2 mo	Product
12042487	Jun 07, 2037	in 11 yr 2 mo	Product
12220409	Jun 07, 2037	in 11 yr 2 mo	Product
12257242	Jun 07, 2037	in 11 yr 2 mo	Product
12310956	Jun 07, 2037	in 11 yr 2 mo	U-3748
12336983	Jun 07, 2037	in 11 yr 2 mo	Product
9884050	Jun 07, 2037	in 11 yr 2 mo	Product
9907788	Jun 07, 2037	in 11 yr 2 mo	U-3712
9907788	Jun 07, 2037	in 11 yr 2 mo	U-3408
11129818	Aug 25, 2037	in 11 yr 4 mo	U-3712
11129818	Aug 25, 2037	in 11 yr 4 mo	U-3408

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo