Drybench Patent.

ROFLUMILAST, NDA 215985

The patents and exclusivities FDA's Orange Book lists for NDA 215985 as captured on 14 October 2026, each date named by its rule and its rows, and the rows of FDA's Paragraph IV list that give this NDA's number, as captured on 17 October 2026. Listed protection is a range of dates, never one date.

FDA capture · review pending. Each row is shown as captured from FDA's Orange Book files and Paragraph IV list. Dates are FDA's own; spreadsheet day numbers are shown as dates, and a cell that cannot be read as one date is shown as written and left out of the range. Where FDA lists a *PED row without flags, its flags are read from the base row and marked so. A Paragraph IV row is placed here only by the number in its RLD/NDA cell; nothing is joined by name. How this page reads FDA's files has not been independently reviewed by a regulatory-affairs reviewer.

Orange Book captured: 14 October 2026
Paragraph IV list captured: 17 October 2026
Last checked: 30 October 2026
Data-branch commit: dadcab56563716abea6c5e31a5e1970080c778ef

Listed protection is a range of the dates FDA lists, not a forecast of market entry, and not legal, regulatory or investment advice.

Dates as listed in FDA's Orange Book capture of 14 October 2026. This page does not say whether a date has passed; compare it with today's date and FDA's current Orange Book. This page shows only what the capture of 14 October 2026 lists. It does not show patents or exclusivities listed before and since removed.

Open in the app ROFLUMILAST in the molecule app

Listed protection

Listed dates run from 5 Oct 2026 to 25 Aug 2037, each by its own rule; no one date stands for this product.

Earliest listed date: 5 Oct 2026NPP exclusivityRule R3 · Product 001 · exclusivity.txt line 1,683
Latest listed date: 25 Aug 2037US 11,129,818, use patentRule R1 · Product 003 · patent.txt line 18,156
Latest substance patent: None listed
Latest listed patent: 25 Aug 2037US 11,129,818, use patentRule R1 · Product 003 · patent.txt line 18,156
Latest exclusivity: 29 Jun 2029NPP exclusivityRule R3 · Product 001 · exclusivity.txt line 1,682

24 use-code patents, blocking the coded use only

Products

Each product number FDA lists under NDA 215985, as listed. The sections below name products by these numbers.

Product 001 · ZORYVE
Dosage form; route
CREAM;TOPICAL
Strength
0.3%
Approval date as listed
29 Jul 2022
Type as listed
RX
Applicant as listed
ARCUTIS BIOTHERAPEUTICS INC
Product 002 · ZORYVE
Dosage form; route
CREAM;TOPICAL
Strength
0.15%
Approval date as listed
9 Jul 2024
Type as listed
RX
Applicant as listed
ARCUTIS BIOTHERAPEUTICS INC
Product 003 · ZORYVE
Dosage form; route
CREAM;TOPICAL
Strength
0.05%
Approval date as listed
4 Oct 2025
Type as listed
RX
Applicant as listed
ARCUTIS BIOTHERAPEUTICS INC

Listed patents

Every patent the FDA lists for this product, as the application holder submitted it, with its flags. The FDA does not verify listings.

35 entries from 57 rows as listed; rows merge only where every cell shown is the same, each with its product numbers.

US 10,940,142, product patent
patent.txt lines 18,116, 18,138, 18,155
Expiry as listed
7 Jun 2037
Rule
R1
Flags
product
Product numbers
001, 002, 003
US 11,793,796, product patent
patent.txt lines 18,120, 18,140, 18,157
Expiry as listed
7 Jun 2037
Rule
R1
Flags
product
Product numbers
001, 002, 003
US 11,819,496, use patent
patent.txt line 18,121
Expiry as listed
7 Jun 2037
Rule
R1
Flags
use code U-3748
Product numbers
001
US 11,819,496, use patent
patent.txt line 18,122
Expiry as listed
7 Jun 2037
Rule
R1
Flags
use code U-4578
Product numbers
001
US 11,819,496, use patent
patent.txt line 18,141
Expiry as listed
7 Jun 2037
Rule
R1
Flags
use code U-3970
Product numbers
002
US 11,819,496, use patent
patent.txt line 18,158
Expiry as listed
7 Jun 2037
Rule
R1
Flags
use code U-4301
Product numbers
003
US 11,992,480, use patent
patent.txt line 18,123
Expiry as listed
7 Jun 2037
Rule
R1
Flags
use code U-4578
Product numbers
001
US 11,992,480, use patent
patent.txt line 18,142
Expiry as listed
7 Jun 2037
Rule
R1
Flags
use code U-3970
Product numbers
002
US 11,992,480, use patent
patent.txt line 18,159
Expiry as listed
7 Jun 2037
Rule
R1
Flags
use code U-4301
Product numbers
003
US 12,005,051, use patent
patent.txt line 18,124
Expiry as listed
7 Jun 2037
Rule
R1
Flags
use code U-4578
Product numbers
001
US 12,005,051, use patent
patent.txt line 18,143
Expiry as listed
7 Jun 2037
Rule
R1
Flags
use code U-3970
Product numbers
002
US 12,005,051, use patent
patent.txt line 18,160
Expiry as listed
7 Jun 2037
Rule
R1
Flags
use code U-4301
Product numbers
003
US 12,005,052, product patent
patent.txt lines 18,125, 18,144, 18,161
Expiry as listed
7 Jun 2037
Rule
R1
Flags
product
Product numbers
001, 002, 003
US 12,011,437, product patent
patent.txt lines 18,126, 18,145, 18,162
Expiry as listed
7 Jun 2037
Rule
R1
Flags
product
Product numbers
001, 002, 003
US 12,016,848, product patent
patent.txt lines 18,127, 18,146, 18,163
Expiry as listed
7 Jun 2037
Rule
R1
Flags
product
Product numbers
001, 002, 003
US 12,042,487, product patent
patent.txt lines 18,128, 18,147, 18,164
Expiry as listed
7 Jun 2037
Rule
R1
Flags
product
Product numbers
001, 002, 003
US 12,220,409, product patent
patent.txt lines 18,129, 18,148, 18,165
Expiry as listed
7 Jun 2037
Rule
R1
Flags
product
Product numbers
001, 002, 003
US 12,257,242, product patent
patent.txt lines 18,130, 18,149, 18,166
Expiry as listed
7 Jun 2037
Rule
R1
Flags
product
Product numbers
001, 002, 003
US 12,310,956, use patent
patent.txt line 18,131
Expiry as listed
7 Jun 2037
Rule
R1
Flags
use code U-4578
Product numbers
001
US 12,310,956, use patent
patent.txt line 18,150
Expiry as listed
7 Jun 2037
Rule
R1
Flags
use code U-3970
Product numbers
002
US 12,310,956, use patent
patent.txt line 18,167
Expiry as listed
7 Jun 2037
Rule
R1
Flags
use code U-4301
Product numbers
003
US 12,336,983, product patent
patent.txt lines 18,132, 18,151, 18,168
Expiry as listed
7 Jun 2037
Rule
R1
Flags
product
Product numbers
001, 002, 003
US 12,685,727, use patent
patent.txt line 18,169
Expiry as listed
7 Jun 2037
Rule
R1
Flags
use code U-4301
Product numbers
003
US 12,697,329, product patent
patent.txt lines 18,133, 18,152, 18,170
Expiry as listed
7 Jun 2037
Rule
R1
Flags
product
Product numbers
001, 002, 003
US 9,884,050, product patent
patent.txt lines 18,134, 18,153, 18,171
Expiry as listed
7 Jun 2037
Rule
R1
Flags
product
Product numbers
001, 002, 003
US 9,907,788, use patent
patent.txt line 18,135
Expiry as listed
7 Jun 2037
Rule
R1
Flags
use code U-3408
Product numbers
001
US 9,907,788, use patent
patent.txt line 18,136
Expiry as listed
7 Jun 2037
Rule
R1
Flags
use code U-3712
Product numbers
001
US 9,907,788, use patent
patent.txt line 18,137
Expiry as listed
7 Jun 2037
Rule
R1
Flags
use code U-4578
Product numbers
001
US 9,907,788, use patent
patent.txt line 18,154
Expiry as listed
7 Jun 2037
Rule
R1
Flags
use code U-3970
Product numbers
002
US 9,907,788, use patent
patent.txt line 18,172
Expiry as listed
7 Jun 2037
Rule
R1
Flags
use code U-4301
Product numbers
003
US 11,129,818, use patent
patent.txt line 18,117
Expiry as listed
25 Aug 2037
Rule
R1
Flags
use code U-3408
Product numbers
001
US 11,129,818, use patent
patent.txt line 18,118
Expiry as listed
25 Aug 2037
Rule
R1
Flags
use code U-3712
Product numbers
001
US 11,129,818, use patent
patent.txt line 18,119
Expiry as listed
25 Aug 2037
Rule
R1
Flags
use code U-4578
Product numbers
001
US 11,129,818, use patent
patent.txt line 18,139
Expiry as listed
25 Aug 2037
Rule
R1
Flags
use code U-3970
Product numbers
002
US 11,129,818, use patent
patent.txt line 18,156
Expiry as listed
25 Aug 2037
Rule
R1
Flags
use code U-4301
Product numbers
003

Listed exclusivities

Each exclusivity FDA lists for NDA 215985, with its code, FDA's definition of the code where the store's code list gives one, and its date as listed.

NPP exclusivity
exclusivity.txt line 1,683
Date
5 Oct 2026
Rule
R3
Definition
New patient population (to be checked against FDA's list)
Product numbers
001
NS exclusivity
exclusivity.txt line 1,684
Date
9 Jul 2027
Rule
R3
Definition
New strength (to be checked against FDA's list)
Product numbers
002
NS exclusivity
exclusivity.txt line 1,685
Date
4 Oct 2028
Rule
R3
Definition
New strength (to be checked against FDA's list)
Product numbers
003
NPP exclusivity
exclusivity.txt line 1,682
Date
29 Jun 2029
Rule
R3
Definition
New patient population (to be checked against FDA's list)
Product numbers
001

Paragraph IV list rows giving NDA 215985

The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 215985, each cell as listed.

FDA's Paragraph IV list names no patent number, so it does not say which of the patents on this page an applicant certified against.

The list gives the last qualifying patent's expiry without pediatric exclusivity; in the app's Patents view, the Orange Book lists any *PED period as a separate row with its own date. The two dates describe different things. A blank cell is one FDA left blank in its list. Dates are FDA's own; the last qualifying patent expiry is not recomputed from the Orange Book.

Rows whose RLD/NDA cell we could not read as exactly one NDA number are kept apart on the list page; some may concern this product.

Rows on FDA's Paragraph IV list whose RLD/NDA cell gives NDA 215985

Roflumilast · Cream · 3.0000000000000001E-3
RLD/NDA as listed: Zoryve 215985
First PIV submission
27 Dec 2023
ANDAs
1
180-day status
blank
Decision posted
blank
First applicant approval
blank
First marketing
blank
Last qualifying patent expiry (as listed by FDA)
7 Jun 2037

Notes from the trace

R6 tentative approvals: not in the Orange Book data files as captured; the Drugs@FDA join is a later ruling.

Patents vs FDA exclusivity How to read the Orange Book data files Paragraph IV certification What changed, by week