FDA Orange Book · active-ingredient family
Aliskiren hemifumarate; valsartan
Aliskiren hemifumarate; valsartan is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:VALTURNA · NDA 022217
1
Brand (NDA)
0
Generics (ANDA)
1
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| VALTURNA×2 | NOVARTIS | NDA 022217 | — | Sep 16, 2009 |
Listed patents (1)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8168616 | Jul 03, 2026 | in 14 d | Product |
Aliskiren hemifumarate; valsartan — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
