Patents Expiring in December 2043

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use
Hikma	DAPTOMYCIN	daptomycin	POWDER;INTRAVENOUS	217415-001	Jan 30, 2023		RX	Yes	Yes	12,629,337		Y
Hikma	DAPTOMYCIN	daptomycin	POWDER;INTRAVENOUS	217415-002	Jan 30, 2023		RX	Yes	Yes	12,629,337		Y
Hikma	HYDROMORPHONE HYDROCHLORIDE	hydromorphone hydrochloride	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	217812-001	Dec 14, 2023		RX	Yes	Yes	12,653,820		Y			USE OF HYDROMORPHONE HYDROCHLORIDE FOR THE MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE AN OPIOID ANALGESIC AND FOR WHICH ALTERNATIVE TREATMENTS ARE INADEQUATE
Vertex Pharms Inc	ALYFTREK	deutivacaftor; tezacaftor; vanzacaftor calcium	TABLET;ORAL	218730-002	Dec 20, 2024		RX	Yes	Yes	12,186,306					TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH 21.4 MG OF VNZ CALCIUM SALT HYDRATE FORM D, 100 MG OF TEZ, AND 250 MG OF D-IVA DAILY
Vertex Pharms Inc	ALYFTREK	deutivacaftor; tezacaftor; vanzacaftor calcium	TABLET;ORAL	218730-002	Dec 20, 2024		RX	Yes	Yes	12,186,306					TREATMENT OF CF WITH VNZ CA SALT HYDRATE FORM D/TEZ/D-IVA (21.24/100/250 MG) IN CF PATIENTS AGED ≥6 Y WITH AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
Neurocrine	CRENESSITY	crinecerfont	CAPSULE;ORAL	218808-001	Dec 13, 2024		RX	Yes	No	12,582,634			Y
Neurocrine	CRENESSITY	crinecerfont	CAPSULE;ORAL	218808-002	Dec 13, 2024		RX	Yes	No	12,582,634			Y