Orange Book product · Brand (NDA)
IONSYS
FENTANYL HYDROCHLORIDE
At a glance
May 22, 2006
Approved
Brand (NDA)
Application
Not listed
TE code
7
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 22, 2006
20 yr 4 mo ago
Today
Patent 8301238 expires
Listed drug product patent expiration.
Sep 30, 2031
in 5 yr 4 mo
Patent 9364656 expires
Listed method-of-use patent (U-736) expiration.
Sep 30, 2031
in 5 yr 4 mo
Patent 9731121 expires
Listed drug product patent expiration.
Oct 17, 2031
in 5 yr 5 mo
Patent 8781571 expires
Listed drug product patent expiration.
Mar 31, 2032
in 5 yr 10 mo
Patent 8428708 expires
Listed method-of-use patent (U-736) expiration.
May 21, 2032
in 6 yr
Patent 8428709 expires
Listed drug product patent expiration.
Jun 11, 2032
in 6 yr 1 mo
Patent 9095706 expires
Listed drug product patent expiration.
Feb 03, 2033
in 6 yr 9 mo
Pharmaceutical detail
Active ingredient
FENTANYL HYDROCHLORIDE
Strength
EQ 40MCG BASE/ACTIVATION
Dosage form
SYSTEM
Route
IONTOPHORESIS, TRANSDERMAL
TE code
Not listed
Application
NDA 021338
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Listed patents (7)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8301238 | Sep 30, 2031 | in 5 yr 4 mo | Product |
| 9364656 | Sep 30, 2031 | in 5 yr 4 mo | U-736 |
| 9731121 | Oct 17, 2031 | in 5 yr 5 mo | Product |
| 8781571 | Mar 31, 2032 | in 5 yr 10 mo | ProductU-736 |
| 8428708 | May 21, 2032 | in 6 yr | U-736 |
| 8428709 | Jun 11, 2032 | in 6 yr 1 mo | ProductU-736 |
| 9095706 | Feb 03, 2033 | in 6 yr 9 mo | Product |
