Is there a generic for Pemetrexed ditromethamine?

The FDA Orange Book does not currently list an approved generic (ANDA) for Pemetrexed ditromethamine. It is available as 1 brand (NDA) application.

What is the reference-listed drug for Pemetrexed ditromethamine?

PEMETREXED DITROMETHAMINE (NDA 208746, HOSPIRA) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Pemetrexed ditromethamine are approved?

Pemetrexed ditromethamine is approved in the following dosage form: powder.

FDA Orange Book · active-ingredient family

Pemetrexed ditromethamine

Pemetrexed ditromethamine is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:PEMETREXED DITROMETHAMINE · NDA 208746

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · powder

Product	Applicant	Application	TE	Approved
PEMETREXED DITROMETHAMINERLD×3	HOSPIRA	NDA 208746	—	Jun 10, 2022

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.

Pemetrexed ditromethamine — frequently asked questions

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

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