berdazimer sodium · Lnhc · NDA 217424
Zelsuvmi
Earliest generic entry, as listed
10 Jul 2035
Blocked by patent: US 10322081, US 10736839, US 11040006, US 11723858.
Listed patents · 12 unexpired
20 Orange Book listing rows for 12 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 10322081 | use U-3793, U-3794, U-3795, U-3796 | 10 Jul 2035 |
| US 10322081 listing row | use U-3793 · sets the listed date | 10 Jul 2035 |
| US 10322081 listing row | use U-3794 · sets the listed date | 10 Jul 2035 |
| US 10322081 listing row | use U-3795 · sets the listed date | 10 Jul 2035 |
| US 10322081 listing row | use U-3796 · sets the listed date | 10 Jul 2035 |
| US 10736839 | use U-3790, U-3791, U-3792 | 10 Jul 2035 |
| US 10736839 listing row | use U-3790 · sets the listed date | 10 Jul 2035 |
| US 10736839 listing row | use U-3791 · sets the listed date | 10 Jul 2035 |
| US 10736839 listing row | use U-3792 · sets the listed date | 10 Jul 2035 |
| US 11040006 | drug product, use U-3789 · sets the listed date | 10 Jul 2035 |
| US 11723858 | drug product, use U-3788 · sets the listed date | 10 Jul 2035 |
| US 10258564 | use U-3797, U-3798, U-3799 | 22 Nov 2034 |
| US 10258564 listing row | use U-3797 | 22 Nov 2034 |
| US 10258564 listing row | use U-3798 | 22 Nov 2034 |
| US 10258564 listing row | use U-3799 | 22 Nov 2034 |
| US 11285098 | drug product | 28 Feb 2034 |
| US 9855211 | drug product, use U-3800, U-3801 | 27 Feb 2034 |
| US 9855211 listing row | drug product, use U-3800 | 27 Feb 2034 |
| US 9855211 listing row | drug product, use U-3801 | 27 Feb 2034 |
| US 10265334 | drug product | 3 Jul 2032 |
| US 9289442 | drug product, use U-3803 | 3 Jul 2032 |
| US 9526738 | drug product | 3 Sep 2031 |
| US 10376538 | drug product | 20 Aug 2030 |
| US 9737561 | use U-3802 | 20 Aug 2030 |
Exclusivities · 1 unexpired
| NCE | new chemical entity (5 years) | 5 Jan 2029 |
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 217424 · 001 · RLD | gel, topical | EQ 10.3% BASE | 10 Jul 2035 |
Expired or delisted (2)
- US 8282967 · substance · 30 May 2026
- US 8956658 · substance · 30 May 2026