FDA Orange Book · active-ingredient family
Sofpironium bromide
Sofpironium bromide is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:SOFDRA · NDA 217347
1
Brand (NDA)
0
Generics (ANDA)
20
Listed patents
1
Exclusivity periods
Brand (NDA) products · gel, metered
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SOFDRARLD | BOTANIX SB | NDA 217347 | — | Jun 18, 2024 |
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 |
| 9492429 | Mar 14, 2034 | in 7 yr 10 mo | ProductU-2398 |
| 9895350 | Mar 14, 2034 | in 7 yr 10 mo | U-2398 |
| 9220707 | Mar 14, 2034 | in 7 yr 10 mo | U-2398 |
| 12357609 | May 22, 2034 | in 8 yr | ProductU-2398 |
| 12156865 | May 22, 2034 | in 8 yr | ProductU-2398 |
| 12398102 | May 22, 2034 | in 8 yr | ProductU-2398 |
| 11084788 | May 22, 2034 | in 8 yr | ProductU-2398 |
| 11052067 | May 22, 2034 | in 8 yr | ProductU-2398 |
| 11034652 | May 22, 2034 | in 8 yr | ProductU-2398 |
| 11026919 | May 22, 2034 | in 8 yr | ProductU-2398 |
| 10961191 | May 22, 2034 | in 8 yr | U-2398 |
| 10959983 | May 22, 2034 | in 8 yr | U-2398 |
| 10952990 | May 22, 2034 | in 8 yr | U-2398 |
| 10947192 | May 22, 2034 | in 8 yr | U-2398 |
| 11123325 | Jul 20, 2037 | in 11 yr 3 mo | ProductU-2398 |
| 11584715 | May 22, 2040 | in 14 yr 2 mo | SubstanceProduct |
| 11566000 | May 22, 2040 | in 14 yr 2 mo | SubstanceProduct |
Sofpironium bromide — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
