amlodipine besylate; hydrochlorothiazide; valsartan · Novartis · NDA 022314
Exforge Hct
Earliest generic entry, as listed · earliest of 5 marketed strengths
Open now
No unexpired patents or exclusivities are listed for this product.
Listed patents · 0 unexpired
No unexpired patents listed.
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 · 5
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 022314 · 001 · RLD | tablet, oral | EQ 5MG BASE;12.5MG;160MG | open |
| 022314 · 002 · RLD | tablet, oral | EQ 5MG BASE;25MG;160MG | open |
| 022314 · 003 · RLD | tablet, oral | EQ 10MG BASE;12.5MG;160MG | open |
| 022314 · 004 · RLD | tablet, oral | EQ 10MG BASE;25MG;160MG | open |
| 022314 · 005 · RLD | tablet, oral | EQ 10MG BASE;25MG;320MG | open |