Last Updated: November 15, 2026

Paragraph IV Challenges

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Tradename	Dosage	Generic Name	NDA	ANDAs Submitted	180 Day Exclusivity Status	Submissiondate
AUSTEDO XR	Extended-release Tablets	deutetrabenazine	216354	1		2026-09-11
MEKINIST	Tablets	trametinib dimethyl sulfoxide	204114	1		2026-08-31
WEGOVY	Tablets	semaglutide	218316	1		2026-08-28
MEKINIST	Tablets	trametinib dimethyl sulfoxide	204114	1		2026-08-26
ZEPBOUND KWIKPEN	Subcutaneous Solution	tirzepatide	217806	1		2026-08-26
OTEZLA XR	Extended-release Tablets	apremilast	210745	1		2026-08-24
>Tradename	>Dosage	>Generic Name	>NDA	>ANDAs Submitted	>180 Day Exclusivity Status	>Submissiondate

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