amlodipine besylate; perindopril arginine · Adhera · NDA 205003
Prestalia
Earliest generic entry, as listed · earliest of 3 marketed strengths
5 Oct 2029
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 7846961.
Listed patents · 1 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 7846961 | drug substance, drug product, use U-3 · sets the listed date | 5 Oct 2029 |
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 |
|---|---|---|---|
| 205003 · 001 · RLD · discontinued | tablet, oral | EQ 2.5MG BASE;3.5MG | 5 Oct 2029 |
| 205003 · 002 · RLD · discontinued | tablet, oral | EQ 5MG BASE;7MG | 5 Oct 2029 |
| 205003 · 003 · RLD · discontinued | tablet, oral | EQ 10MG BASE;14MG | 5 Oct 2029 |