Orange Book product · Brand (NDA)
QSYMIA
PHENTERMINE HYDROCHLORIDE; TOPIRAMATE
At a glance
Jul 17, 2012
Approved
Brand (NDA)
Application
AB
TE code
6
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 17, 2012
14 yr 2 mo ago
Today
Exclusivity ends · M-308
New use / labeling-change exclusivity (3 years)
Sep 13, 2027
in 1 yr 3 mo
Patent 8895057 expires
Listed method-of-use patent (U-3398) expiration.
Jun 09, 2028
in 2 yr
Patent 8895058 expires
Listed drug product patent expiration.
Jun 09, 2028
in 2 yr
Patent 9011905 expires
Listed drug product patent expiration.
Jun 09, 2028
in 2 yr
Patent 9011906 expires
Listed method-of-use patent (U-3398) expiration.
Jun 09, 2028
in 2 yr
Patent 8580298 expires
Listed drug product patent expiration.
May 15, 2029
in 2 yr 11 mo
Patent 8580299 expires
Listed method-of-use patent (U-3399) expiration.
Jun 14, 2029
in 3 yr
Pharmaceutical detail
Active ingredient
PHENTERMINE HYDROCHLORIDE; TOPIRAMATE
Strength
EQ 3.75MG BASE;23MG
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
TE code
AB
Application
NDA 022580
Product number
001
Marketing status
RX
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.
Marketing exclusivity (1)
- M-308New use / labeling-change exclusivity (3 years)
Sep 13, 2027
in 1 yr 3 mo
Listed patents (6)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8895057 | Jun 09, 2028 | in 2 yr | U-3398 |
| 8895058 | Jun 09, 2028 | in 2 yr | Product |
| 9011905 | Jun 09, 2028 | in 2 yr | Product |
| 9011906 | Jun 09, 2028 | in 2 yr | U-3398 |
| 8580298 | May 15, 2029 | in 2 yr 11 mo | Product |
| 8580299 | Jun 14, 2029 | in 3 yr | U-3399 |
