FDA Orange Book
Generic for Folotyn
Folotyn contains pralatrexate. 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 Folotyn is pralatrexate. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Folotyn products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, intravenous | 20MG/ML (20MG/ML) | Marketed (Rx) | AP | 1 | AP |
| solution, intravenous | 40MG/2ML (20MG/ML) | Marketed (Rx) | AP | 1 | AP |
NDA 022468, held by ACROTECH BIOPHARMA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic pralatrexate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| DR REDDYS LABORATORIES LTD | 206183 | AP (A-rated, therapeutically equivalent) | March 10, 2025 | 20MG/ML (20MG/ML), 40MG/2ML (20MG/ML) |
Folotyn NDC codes
Questions
Is there a generic for Folotyn?
Yes. The generic name for Folotyn is pralatrexate. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
What is the generic name for Folotyn?
The active ingredient in Folotyn is pralatrexate, 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.