FDA Orange Book · active-ingredient family
Aliskiren hemifumarate; hydrochlorothiazide
Aliskiren hemifumarate; hydrochlorothiazide is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:TEKTURNA HCT · NDA 022107
1
Brand (NDA)
0
Generics (ANDA)
1
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TEKTURNA HCTRLD×4 | NODEN PHARMA | NDA 022107 | — | Jan 18, 2008 |
Listed patents (1)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8618172 | Jul 13, 2028 | in 2 yr 1 mo | Product |
Aliskiren hemifumarate; hydrochlorothiazide — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

