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Last Updated: March 18, 2026

DrugPatentWatch Alpha Signals Regulatory Exclusivity

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Drug Search Regulatory Exclusivity

Regulatory Exclusivity: New Indication

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Drugs with New Indication Regulatory Exclusivity

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Exclusivity Expiration	Patented / Exclusive Use
Incyte Corp	OPZELURA	ruxolitinib phosphate	CREAM;TOPICAL	215309-001	Sep 21, 2021		RX	Yes	Yes	⤷ Get Started Free	INDICATED FOR THE TOPICAL TREATMENT OF NONSEGMENTAL VITILIGO IN ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
Beone Medicines Usa	BRUKINSA	zanubrutinib	CAPSULE;ORAL	213217-001	Nov 14, 2019		DISCN	Yes	No	⤷ Get Started Free	TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)OR SMALL LYMPHOCYTIC LYMPHOMA (SLL)
Beone Medicines Usa	BRUKINSA	zanubrutinib	TABLET;ORAL	218785-001	Jun 10, 2025		RX	Yes	Yes	⤷ Get Started Free	TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)OR SMALL LYMPHOCYTIC LYMPHOMA (SLL)
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Exclusivity Expiration	>Patented / Exclusive Use

Regulatory Exclusivity

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Competitive Generic Therapy
New Chemical Entity
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Orphan Drug
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RX to OTC Switch

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