Is there a generic for Pemetrexed dipotassium?

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

What is the reference-listed drug for Pemetrexed dipotassium?

AXTLE (NDA 210661, AVYXA HOLDINGS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Pemetrexed dipotassium are approved?

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

FDA Orange Book · active-ingredient family

Pemetrexed dipotassium

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

Reference-listed drug:AXTLE · NDA 210661

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · powder

Product	Applicant	Application	TE	Approved
AXTLERLD×2	AVYXA HOLDINGS	NDA 210661	—	Jun 28, 2024

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 dipotassium — frequently asked questions

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

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