elacestrant hydrochloride · Stemline Therap · NDA 217639
Orserdu
Earliest generic entry, as listed · earliest of 2 marketed strengths
5 Jan 2038
Blocked by patent: US 10385008, US 10745343.
Listed patents · 6 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10385008 | drug substance, drug product · sets the listed date | 5 Jan 2038 |
| US 10745343 | use U-3523 · sets the listed date | 5 Jan 2038 |
| US 11819480 | use U-3523 | 28 Feb 2037 |
| US 10420734 | use U-3524 | 3 Oct 2036 |
| US 10071066 | use U-3524 | 10 Oct 2034 |
| US 11779552 | use U-3524 | 10 Oct 2034 |
Exclusivities · 1 unexpired
| NCE | new chemical entity (5 years) | 27 Jan 2028 |
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 · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 217639 · 001 · RLD | tablet, oral | EQ 86MG BASE | 5 Jan 2038 |
| 217639 · 002 · RLD | tablet, oral | EQ 345MG BASE | 5 Jan 2038 |
Expired or delisted (1)
- US 7612114 · substance, product, use U-3523 · 18 Aug 2026