Is there a generic for Aliskiren hemifumarate?

Yes. The FDA Orange Book lists 1 approved generic (ANDA) application for Aliskiren hemifumarate, referencing the brand TEKTURNA. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Aliskiren hemifumarate?

TEKTURNA (NDA 210709, NODEN PHARMA) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Aliskiren hemifumarate?

The Orange Book lists 2 patents against Aliskiren hemifumarate products, with the earliest listed expiry in 2026. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

What dosage forms of Aliskiren hemifumarate are approved?

Aliskiren hemifumarate is approved in the following dosage forms: capsule, pellet, tablet.

FDA Orange Book · active-ingredient family

Aliskiren hemifumarate

Aliskiren hemifumarate: 2 brands, 1 generic; first approved Mar 05, 2007; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available: 1 ANDA application approved.

Earliest patent expiry Feb 19, 2026

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Feb 19, 2026

6 mo ago

Brand (NDA) products

Originator applications

TEKTURNARLD
NODEN PHARMANDA 2107092017
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 37.5MG BASE CAPSULE, PELLET ORAL Discontinued —
TEKTURNARLD
LXO IRELANDNDA 02198520072 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 150MG BASE TABLET ORAL Rx AB
EQ 300MG BASE TABLET ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 37.5MG BASE	CAPSULE, PELLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 150MG BASE	TABLET	ORAL	Rx	AB
EQ 300MG BASE	TABLET	ORAL	Rx	AB

Generic (ANDA) products (1)

Abbreviated applications

ALISKIREN HEMIFUMARATE
PH HEALTHANDA 20666520192 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 150MG BASE TABLET ORAL Rx AB
EQ 300MG BASE TABLET ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 150MG BASE	TABLET	ORAL	Rx	AB
EQ 300MG BASE	TABLET	ORAL	Rx	AB

Patent & exclusivity timeline

Protection horizon

Patent expiryExclusivity endToday

Listed patents

Orange Book patent file

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8617595	Feb 19, 2026	6 mo ago	Product
8617595*PED	Aug 19, 2026	in 7 d

Approval history

FDA approval span

First approval

Mar 05, 2007

19 yr 9 mo ago

Most recent approval

Mar 22, 2019

7 yr 6 mo ago

Approvals span 2007–2019 across 3 FDA applications.

Brand (NDA) 267%

Generic (ANDA) 133%

Aliskiren hemifumarate: 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.

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