Last Updated: September 29, 2026

Paragraph IV Challenges

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Tradename	Dosage	Generic Name	NDA	ANDAs Submitted	180 Day Exclusivity Status	Submissiondate
MEKINIST	Tablets	trametinib dimethyl sulfoxide	204114	1		2026-08-31
ZEPBOUND KWIKPEN	Subcutaneous Solution	tirzepatide	217806	1		2026-08-26
MOUNJARO KWIKPEN	Subcutaneous Solution	tirzepatide	215866	1		2026-08-24
ZEPBOUND KWIKPEN	Subcutaneous Solution	tirzepatide	217806	1		2026-08-24
KOSELUGO	Capsules	selumetinib sulfate	213756	1		2026-08-04
TONMYA	Sublingual Tablets	cyclobenzaprine hydrochloride	219428	1		2026-07-29
>Tradename	>Dosage	>Generic Name	>NDA	>ANDAs Submitted	>180 Day Exclusivity Status	>Submissiondate

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