Orange Book product · Brand (NDA)
SOFDRA
SOFPIRONIUM BROMIDE
At a glance
Jun 18, 2024
Approved
Brand (NDA)
Application
Not listed
TE code
20
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 18, 2024
2 yr ago
Today
Patent 8628759 expires
Listed method-of-use patent (U-2398) expiration.
Nov 13, 2026
in 5 mo
Patent 8147809 expires
Listed drug substance patent expiration.
Mar 26, 2027
in 9 mo
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Jun 20, 2029
in 3 yr 1 mo
Patent 10383846 expires
Listed method-of-use patent (U-2398) expiration.
Mar 14, 2034
in 7 yr 10 mo
Patent 9220707 expires
Listed method-of-use patent (U-2398) expiration.
Mar 14, 2034
in 7 yr 10 mo
Patent 9492429 expires
Listed drug product patent expiration.
Mar 14, 2034
in 7 yr 10 mo
Patent 9895350 expires
Listed method-of-use patent (U-2398) expiration.
Mar 14, 2034
in 7 yr 10 mo
Patent 10947192 expires
Listed method-of-use patent (U-2398) expiration.
May 22, 2034
in 8 yr
Patent 10952990 expires
Listed method-of-use patent (U-2398) expiration.
May 22, 2034
in 8 yr
Patent 10959983 expires
Listed method-of-use patent (U-2398) expiration.
May 22, 2034
in 8 yr
Patent 10961191 expires
Listed method-of-use patent (U-2398) expiration.
May 22, 2034
in 8 yr
Patent 11026919 expires
Listed drug product patent expiration.
May 22, 2034
in 8 yr
Patent 11034652 expires
Listed drug product patent expiration.
May 22, 2034
in 8 yr
Patent 11052067 expires
Listed drug product patent expiration.
May 22, 2034
in 8 yr
Patent 11084788 expires
Listed drug product patent expiration.
May 22, 2034
in 8 yr
Patent 12156865 expires
Listed drug product patent expiration.
May 22, 2034
in 8 yr
Patent 12357609 expires
Listed drug product patent expiration.
May 22, 2034
in 8 yr
Patent 12398102 expires
Listed drug product patent expiration.
May 22, 2034
in 8 yr
Patent 11123325 expires
Listed drug product patent expiration.
Jul 20, 2037
in 11 yr 3 mo
Patent 11566000 expires
Listed drug substance patent expiration.
May 22, 2040
in 14 yr 2 mo
Patent 11584715 expires
Listed drug substance patent expiration.
May 22, 2040
in 14 yr 2 mo
Pharmaceutical detail
Active ingredient
SOFPIRONIUM BROMIDE
Strength
EQ 12.45% BASE (EQ 72MG BASE/ACTUATION)
Dosage form
GEL, METERED
Route
TOPICAL
TE code
Not listed
Application
NDA 217347
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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)
- NCENew chemical entity exclusivity (5 years)
Jun 20, 2029
in 3 yr 1 mo
Listed patents (20)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8628759 | Nov 13, 2026 | in 5 mo | U-2398 |
| 8147809 | Mar 26, 2027 | in 9 mo | SubstanceProduct |
| 10383846 | Mar 14, 2034 | in 7 yr 10 mo | U-2398 |
| 9220707 | Mar 14, 2034 | in 7 yr 10 mo | U-2398 |
| 9492429 | Mar 14, 2034 | in 7 yr 10 mo | ProductU-2398 |
| 9895350 | Mar 14, 2034 | in 7 yr 10 mo | U-2398 |
| 10947192 | May 22, 2034 | in 8 yr | U-2398 |
| 10952990 | May 22, 2034 | in 8 yr | U-2398 |
| 10959983 | May 22, 2034 | in 8 yr | U-2398 |
| 10961191 | May 22, 2034 | in 8 yr | U-2398 |
| 11026919 | May 22, 2034 | in 8 yr | ProductU-2398 |
| 11034652 | May 22, 2034 | in 8 yr | ProductU-2398 |
| 11052067 | May 22, 2034 | in 8 yr | ProductU-2398 |
| 11084788 | May 22, 2034 | in 8 yr | ProductU-2398 |
| 12156865 | May 22, 2034 | in 8 yr | ProductU-2398 |
| 12357609 | May 22, 2034 | in 8 yr | ProductU-2398 |
| 12398102 | May 22, 2034 | in 8 yr | ProductU-2398 |
| 11123325 | Jul 20, 2037 | in 11 yr 3 mo | ProductU-2398 |
| 11566000 | May 22, 2040 | in 14 yr 2 mo | SubstanceProduct |
| 11584715 | May 22, 2040 | in 14 yr 2 mo | SubstanceProduct |
