Last Updated: August 15, 2026

Paragraph IV Challenges

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Tradename	Dosage	Generic Name	NDA	ANDAs Submitted	180 Day Exclusivity Status	Submissiondate
LUMRYZ	For Extended- release Oral Suspension	sodium oxybate	214755	1		2026-05-22
MOUNJARO KWIKPEN	Subcutaneous Solution	tirzepatide	215866	1		2026-05-13
ZEPBOUND KWIKPEN	Subcutaneous Solution	tirzepatide	217806	1		2026-05-13
RASUVO	Subcutaneous Injection	methotrexate	205776	1		2026-05-04
CAMZYOS	Capsules	mavacamten	214998	7		2026-04-28
>Tradename	>Dosage	>Generic Name	>NDA	>ANDAs Submitted	>180 Day Exclusivity Status	>Submissiondate

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