FDA Orange Book · active-ingredient family
Aliskiren hemifumarate; hydrochlorothiazide
Aliskiren hemifumarate; hydrochlorothiazide: 1 brand, 0 generics; first approved Jan 18, 2008; on patent until Jul 13, 2028.
On patentHas discontinued products
Generic status & protection
Protected until Jul 13, 2028 (earliest listed patent expiry).
Earliest patent expiry Jul 13, 2028
Brands (NDA)
1
Generics (ANDA)
0
Listed patents
1
Next patent expiry
Jul 13, 2028
in 2 yr
Originator applications
Brand (NDA) products
TEKTURNA HCTRLDNODEN PHARMANDA 02210720084 strengths
TEKTURNA HCTRLD
NODEN PHARMANDA 02210720084 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| EQ 150MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | ORAL | Discontinued | — |
| EQ 150MG BASE;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | ORAL | Discontinued | — |
| EQ 300MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | ORAL | Discontinued | — |
| EQ 300MG BASE;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | ORAL | Discontinued | — |
Protection horizon
Patent & exclusivity timeline
Patent expiryExclusivity endToday
Orange Book patent file
Listed patents
Listed patents (1)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8618172 | Jul 13, 2028 | in 2 yr | Product |
FDA approval span
Approval history
First approval
Jan 18, 2008
18 yr 9 mo ago
Most recent approval
Jan 18, 2008
18 yr 9 mo ago
All 1 application were approved in 2008.
Brand (NDA) 1100%
Generic (ANDA) 00%
Aliskiren hemifumarate; hydrochlorothiazide — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
