sarecycline hydrochloride · Almirall · NDA 209521
Seysara
Earliest generic entry, as listed · earliest of 3 marketed strengths
9 Feb 2033
Blocked by patent: US 9255068.
Listed patents · 4 unexpired
5 Orange Book listing rows for 4 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 9255068 | drug substance, drug product, use U-2407, U-2408 | 9 Feb 2033 |
| US 9255068 listing row | drug substance, drug product, use U-2407 · sets the listed date | 9 Feb 2033 |
| US 9255068 listing row | drug substance, drug product, use U-2408 · sets the listed date | 9 Feb 2033 |
| US 8318706 | drug substance, drug product, use U-2405 | 3 Jan 2032 |
| US 8513223 | use U-2406 | 7 Dec 2029 |
| US 9481639 | use U-2409 | 10 Aug 2028 |
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 · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 209521 · 001 · RLD | tablet, oral | EQ 60MG BASE | 9 Feb 2033 |
| 209521 · 002 · RLD | tablet, oral | EQ 100MG BASE | 9 Feb 2033 |
| 209521 · 003 · RLD | tablet, oral | EQ 150MG BASE | 9 Feb 2033 |