betamethasone dipropionate; calcipotriene · Leo Pharma As · NDA 207589
Enstilar
Earliest generic entry, as listed
10 Dec 2031
Blocked by patent: US 10130640 (pediatric extension), US 9119781 (pediatric extension).
Listed patents · 8 unexpired
11 Orange Book listing rows for 8 patents, including 2 pediatric extensions. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 10130640 | drug product | 10 Dec 2031 |
| US 10130640 listing row | drug product | 10 Jun 2031 |
| US 10130640 listing row | pediatric extension · sets the listed date | 10 Dec 2031 |
| US 9119781 | drug product, use U-1761, U-2627 | 10 Dec 2031 |
| US 9119781 listing row | drug product, use U-1761 | 10 Jun 2031 |
| US 9119781 listing row | drug product, use U-2627 | 10 Jun 2031 |
| US 9119781 listing row | pediatric extension · sets the listed date | 10 Dec 2031 |
| US 10617698 | drug product | 10 Jun 2031 |
| US 10660908 | drug product, use U-2627 | 10 Jun 2031 |
| US 10682364 | drug product | 10 Jun 2031 |
| US 10688108 | use U-2627 | 10 Jun 2031 |
| US 10716799 | drug product | 10 Jun 2031 |
| US 9566286 | drug product | 10 Jun 2031 |
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
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 |
|---|---|---|---|
| 207589 · 001 · RLD | aerosol, foam, topical | 0.064%;0.005% | 10 Dec 2031 |