Is there a generic for Abarelix?

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

What is the reference-listed drug for Abarelix?

PLENAXIS (NDA 021320, SPECIALITY EUROPEAN) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Abarelix are approved?

Abarelix is approved in the following dosage form: powder.

FDA Orange Book · active-ingredient family

Abarelix

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

Reference-listed drug:PLENAXIS · NDA 021320

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · powder

Product	Applicant	Application	TE	Approved
PLENAXIS	SPECIALITY EUROPEAN	NDA 021320	—	Nov 25, 2003

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.

Abarelix — frequently asked questions

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

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