FDA Orange Book · active-ingredient family
Aliskiren hemifumarate
Aliskiren hemifumarate is approved as 2 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:TEKTURNA · NDA 210709
2
Brand (NDA)
1
Generics (ANDA)
2
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, pellet, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TEKTURNARLD | NODEN PHARMA | NDA 210709 | — | Nov 14, 2017 | |
| TEKTURNARLD×2 | LXO IRELAND | NDA 021985 | AB | Mar 05, 2007 |
Generic (ANDA) products (1)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ALISKIREN HEMIFUMARATE×2 | PH HEALTH | ANDA 206665 | AB | Mar 22, 2019 |
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8617595 | Feb 19, 2026 | 4 mo ago | Product |
| 8617595*PED | Aug 19, 2026 | in 2 mo |
Aliskiren hemifumarate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
