aliskiren hemifumarate; amlodipine besylate · Novartis · NDA 022545
Tekamlo
Earliest generic entry, as listed · earliest of 4 marketed strengths
21 Dec 2029
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 8613949.
Listed patents · 1 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8613949 | product | 21 Dec 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 · 4
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 022545 · 001 · discontinued | tablet, oral | EQ 150MG BASE;EQ 5MG BASE | 21 Dec 2029 |
| 022545 · 002 · discontinued | tablet, oral | EQ 150MG BASE;EQ 10MG BASE | 21 Dec 2029 |
| 022545 · 003 · discontinued | tablet, oral | EQ 300MG BASE;EQ 5MG BASE | 21 Dec 2029 |
| 022545 · 004 · discontinued | tablet, oral | EQ 300MG BASE;EQ 10MG BASE | 21 Dec 2029 |