FDA Orange Book · active-ingredient family
Nerandomilast
Nerandomilast is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:JASCAYD · NDA 218764
1
Brand (NDA)
0
Generics (ANDA)
5
Listed patents
6
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| JASCAYDRLD×2 | BOEHRINGER INGELHEIM | NDA 218764 | — | Oct 07, 2025 |
Marketing exclusivity (6)
- I-979New indication exclusivity (3 years)
Dec 19, 2028
in 2 yr 6 mo
- NCENew chemical entity exclusivity (5 years)
Oct 07, 2030
in 4 yr 4 mo
- ODE-546Orphan-drug exclusivity (7 years)
Oct 07, 2032
in 6 yr 5 mo
- I-979New indication exclusivity (3 years)
Dec 19, 2028
in 2 yr 6 mo
- NCENew chemical entity exclusivity (5 years)
Oct 07, 2030
in 4 yr 4 mo
- ODE-546Orphan-drug exclusivity (7 years)
Oct 07, 2032
in 6 yr 5 mo
Listed patents (5)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8754073 | Nov 26, 2029 | in 3 yr 6 mo | SubstanceProductU-4298 |
| 8609670 | Aug 23, 2032 | in 6 yr 3 mo | Substance |
| 9802954 | Feb 19, 2034 | in 7 yr 9 mo | U-4298 |
| 11813266 | Oct 22, 2038 | in 12 yr 6 mo | U-4372 |
| 11406638 | Oct 22, 2038 | in 12 yr 6 mo | U-4373 |
Nerandomilast — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
