FDA Orange Book
Generic for Agrylin
Agrylin contains anagrelide. 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 Agrylin is anagrelide. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Agrylin products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | EQ 0.5MG BASE | Marketed (Rx) | AB | 4 | AB |
| capsule, oral | EQ 1MG BASE | Discontinued | None | 4 | AB |
NDA 020333, held by TAKEDA PHARMACEUTICALS USA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic anagrelide
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| CIPLA LTD | 076468 | AB (A-rated, therapeutically equivalent) | April 18, 2005 | EQ 0.5MG BASE, EQ 1MG BASE |
| IMPAX LABORATORIES INC | 076910 | AB (A-rated, therapeutically equivalent) | April 18, 2005 | EQ 0.5MG BASE, EQ 1MG BASE |
| NOVITIUM PHARMA LLC | 076811 | AB (A-rated, therapeutically equivalent) | April 18, 2005 | EQ 0.5MG BASE, EQ 1MG BASE |
| TORRENT PHARMACEUTICALS LTD | 209151 | AB (A-rated, therapeutically equivalent) | June 30, 2017 | EQ 0.5MG BASE, EQ 1MG BASE |
Agrylin NDC codes
Questions
Is there a generic for Agrylin?
Yes. The generic name for Agrylin is anagrelide. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Agrylin?
The active ingredient in Agrylin is anagrelide, per the FDA Orange Book.
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.