Is there a generic for Pralatrexate?

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

What is the reference-listed drug for Pralatrexate?

FOLOTYN (NDA 022468, ACROTECH BIOPHARMA) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Pralatrexate are approved?

Pralatrexate is approved in the following dosage form: solution.

FDA Orange Book · active-ingredient family

Pralatrexate

Pralatrexate is approved as 1 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:FOLOTYN · NDA 022468

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · solution

Product	Applicant	Application	TE	Approved
FOLOTYNRLD×2	ACROTECH BIOPHARMA	NDA 022468	AP	Sep 24, 2009

Generic (ANDA) products (1)

Product	Applicant	Application	TE	Approved
PRALATREXATE×2	DR REDDYS	ANDA 206183	AP	Mar 10, 2025

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Pralatrexate — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo