Last Updated: May 2, 2026

DrugPatentWatch Alpha Signals Regulatory Exclusivity

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Regulatory Exclusivity: New Product

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Drugs with New Product Regulatory Exclusivity

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Exclusivity Expiration	Patented / Exclusive Use
Talicia Holdings	TALICIA	amoxicillin; omeprazole magnesium; rifabutin	CAPSULE, DELAYED RELEASE;ORAL	213004-001	Nov 1, 2019		RX	Yes	Yes	⤷ Start Trial	NEW PRODUCT
Organon Llc	XACIATO	clindamycin phosphate	GEL;VAGINAL	215650-001	Dec 7, 2021		RX	Yes	Yes	⤷ Start Trial	NEW PRODUCT
Pharmacyclics Llc	IMBRUVICA	ibrutinib	SUSPENSION;ORAL	217003-001	Aug 24, 2022		RX	Yes	Yes	⤷ Start Trial	NEW PRODUCT
Astrazeneca	AIRSUPRA	albuterol sulfate; budesonide	AEROSOL, METERED;INHALATION	214070-001	Jan 10, 2023		RX	Yes	Yes	⤷ Start Trial	NEW PRODUCT
Apellis Pharms	SYFOVRE	pegcetacoplan	SOLUTION;INTRAVITREAL	217171-001	Feb 17, 2023		RX	Yes	Yes	⤷ Start Trial	NEW PRODUCT
Aft Pharms Us	COMBOGESIC	acetaminophen; ibuprofen	TABLET;ORAL	209471-001	Mar 1, 2023		RX	Yes	Yes	⤷ Start Trial	NEW PRODUCT
>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
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