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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 021320

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NDA 021320 describes PLENAXIS, which is a drug marketed by Speciality European and is included in one NDA. Additional details are available on the PLENAXIS profile page.

The generic ingredient in PLENAXIS is abarelix. Additional details are available on the abarelix profile page.

Summary for 021320

Tradename:	PLENAXIS
Applicant:	Speciality European
Ingredient:	abarelix
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INTRAMUSCULAR			Strength	100MG/VIAL
Approval Date:	Nov 25, 2003	TE:		RLD:	No

Expired US Patents for NDA 021320

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Speciality European	PLENAXIS	abarelix	INJECTABLE;INTRAMUSCULAR	021320-001	Nov 25, 2003	5,843,901	⤷ Get Started Free
Speciality European	PLENAXIS	abarelix	INJECTABLE;INTRAMUSCULAR	021320-001	Nov 25, 2003	6,699,833	⤷ Get Started Free
Speciality European	PLENAXIS	abarelix	INJECTABLE;INTRAMUSCULAR	021320-001	Nov 25, 2003	6,423,686	⤷ Get Started Free
Speciality European	PLENAXIS	abarelix	INJECTABLE;INTRAMUSCULAR	021320-001	Nov 25, 2003	6,455,499	⤷ Get Started Free
Speciality European	PLENAXIS	abarelix	INJECTABLE;INTRAMUSCULAR	021320-001	Nov 25, 2003	6,180,608	⤷ Get Started Free
Speciality European	PLENAXIS	abarelix	INJECTABLE;INTRAMUSCULAR	021320-001	Nov 25, 2003	5,968,895	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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