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: 1 brand, 1 generic; first approved Sep 24, 2009; generic available.

Generic available

Generic status & protection

Generic available — 1 ANDA application approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Originator applications

Brand (NDA) products

FOLOTYNRLD

ACROTECH BIOPHARMANDA 02246820092 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
20MG/ML (20MG/ML)	SOLUTION	INTRAVENOUS	Rx	AP
40MG/2ML (20MG/ML)	SOLUTION	INTRAVENOUS	Rx	AP

Abbreviated applications

Generic (ANDA) products (1)

PRALATREXATE

DR REDDYSANDA 20618320252 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
20MG/ML (20MG/ML)	SOLUTION	INTRAVENOUS	Rx	AP
40MG/2ML (20MG/ML)	SOLUTION	INTRAVENOUS	Rx	AP

Orange Book patent file

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.

FDA approval span

Approval history

First approval

Sep 24, 2009

17 yr ago

Most recent approval

Mar 10, 2025

1 yr 4 mo ago

Approvals span 2009–2025 across 2 FDA applications.

Brand (NDA) 150%

Generic (ANDA) 150%

Pralatrexate — 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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