Last Updated: August 26, 2026

Regulatory Exclusivity: NEW STRENGTH

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Drugs with New Strength Regulatory Exclusivity

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Exclusivity Expiration	Patented / Exclusive Use
Abbvie Endocrine Inc	LUPRON DEPOT-PED KIT	leuprolide acetate	POWDER;INTRAMUSCULAR	020263-009	Apr 14, 2023		RX	Yes	Yes	⤷ Start Trial	NEW STRENGTH
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-003	May 12, 2023		RX	Yes	Yes	⤷ Start Trial	NEW STRENGTH
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-004	Oct 2, 2023		RX	Yes	No	⤷ Start Trial	NEW STRENGTH
Arcutis	ZORYVE	roflumilast	CREAM;TOPICAL	215985-002	Jul 9, 2024		RX	Yes	Yes	⤷ Start Trial	NEW STRENGTH
Bristol Myers Squibb	ELIQUIS	apixaban	TABLET, FOR SUSPENSION;ORAL	202155-003	Apr 17, 2025		RX	Yes	Yes	⤷ Start Trial	NEW STRENGTH
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Exclusivity Expiration	>Patented / Exclusive Use

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