Orange Book product · Brand (NDA)

SUBSYS

FENTANYL

Brand (NDA)NDA 202788DISCN BTCP PHARMA

Jan 04, 2012

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jan 04, 2012
14 yr 8 mo ago
Today
Patent 10016403 expires
Listed drug product patent expiration.
Jan 25, 2027
in 7 mo
Patent 10610523 expires
Listed drug product patent expiration.
Jan 25, 2027
in 7 mo
Patent 8835459 expires
Listed drug product patent expiration.
Jan 25, 2027
in 7 mo
Patent 8835460 expires
Listed drug product patent expiration.
Jan 25, 2027
in 7 mo
Patent 9241935 expires
Listed drug product patent expiration.
Jan 25, 2027
in 7 mo
Patent 9289387 expires
Listed drug product patent expiration.
Jan 25, 2027
in 7 mo
Patent 9642797 expires
Listed drug product patent expiration.
Jan 25, 2027
in 7 mo
Patent 9642844 expires
Listed drug product patent expiration.
Jan 25, 2027
in 7 mo
Patent 8486972 expires
Listed drug product patent expiration.
Apr 27, 2030
in 3 yr 11 mo
Patent 8486973 expires
Listed method-of-use patent (U-55) expiration.
Apr 27, 2030
in 3 yr 11 mo

Active ingredient

FENTANYL

Strength

0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage form

SPRAY

Route

SUBLINGUAL

TE code

Not listed

Application

NDA 202788

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

Active-ingredient family

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

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
10016403	Jan 25, 2027	in 7 mo	Product
10610523	Jan 25, 2027	in 7 mo	Product
8835459	Jan 25, 2027	in 7 mo	Product
8835460	Jan 25, 2027	in 7 mo	ProductU-55
9241935	Jan 25, 2027	in 7 mo	Product
9289387	Jan 25, 2027	in 7 mo	ProductU-55
9642797	Jan 25, 2027	in 7 mo	ProductU-55
9642844	Jan 25, 2027	in 7 mo	Product
8486972	Apr 27, 2030	in 3 yr 11 mo	Product
8486973	Apr 27, 2030	in 3 yr 11 mo	U-55