FDA Orange Book
Generic for Tekturna
Tekturna contains aliskiren. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Tekturna is aliskiren. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 2 of the 3 Tekturna products the Orange Book lists.
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Tekturna products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, pellet, oral | EQ 37.5MG BASE | Discontinued | None | 0 | None |
| tablet, oral | EQ 150MG BASE | Marketed (Rx) | AB | 1 | AB |
| tablet, oral | EQ 300MG BASE | Marketed (Rx) | AB | 1 | AB |
NDA 210709, 021985, held by NODEN PHARMA DAC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic aliskiren
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| PH HEALTH LTD | 206665 | AB (A-rated, therapeutically equivalent) | March 22, 2019 | EQ 150MG BASE, EQ 300MG BASE |
Tekturna patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8617595 | February 19, 2026 | Drug product | None | 021985 |
| 8617595*PED | August 19, 2026 | Method of use | None | 021985 |
Tekturna NDC codes
Questions
Is there a generic for Tekturna?
Yes. The generic name for Tekturna is aliskiren. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 2 of the 3 Tekturna products the Orange Book lists.
What is the generic name for Tekturna?
The active ingredient in Tekturna is aliskiren, per the FDA Orange Book.
When does the Tekturna patent expire?
The last patent listed for Tekturna in the Orange Book expires August 19, 2026. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.