Last Updated: May 12, 2026

Paragraph IV Challenges

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Tradename	Dosage	Generic Name	NDA	ANDAs Submitted	180 Day Exclusivity Status	Submissiondate
SPINRAZA	Intrathecal Solution	nusinersen sodium	209531	1		2026-03-10
AUSTEDO XR	Extended-release Tablets	deutetrabenazine	216354	1		2026-03-02
RINVOQ LQ	Oral Solution	upadacitinib	218347	1		2026-03-02
PYRUKYND	Tablets	mitapivat sulfate	216196	1		2026-02-17
EVRYSDI	Tablets	risdiplam	219285	1		2026-02-17
MOTPOLY XR	Extended-release Capsules	lacosamide	216185	1		2026-02-10
>Tradename	>Dosage	>Generic Name	>NDA	>ANDAs Submitted	>180 Day Exclusivity Status	>Submissiondate

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