Uswm Company Profile

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USWM has four approved drugs.

There is one US patent protecting USWM drugs.

There are five patent family members on USWM drugs in five countries and eight supplementary protection certificates in seven countries.

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Uswm	CORGARD	nadolol	TABLET;ORAL	018063-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No		⤷ Start Trial				⤷ Start Trial
Uswm	IWILFIN	eflornithine hydrochloride	TABLET;ORAL	215500-001	Dec 13, 2023		RX	Yes	Yes	12,582,625	⤷ Start Trial				⤷ Start Trial
Uswm	CORGARD	nadolol	TABLET;ORAL	018063-004	Approved Prior to Jan 1, 1982		DISCN	No	No		⤷ Start Trial				⤷ Start Trial
Uswm	IWILFIN	eflornithine hydrochloride	TABLET;ORAL	215500-001	Dec 13, 2023		RX	Yes	Yes		⤷ Start Trial				⤷ Start Trial
Uswm	CORGARD	nadolol	TABLET;ORAL	018063-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No		⤷ Start Trial				⤷ Start Trial
Uswm	REVONTO	dantrolene sodium	INJECTABLE;INJECTION	078378-001	Jul 24, 2007	AP	RX	No	No		⤷ Start Trial				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Uswm	CORGARD	nadolol	TABLET;ORAL	018063-002	Approved Prior to Jan 1, 1982	3,982,021	⤷ Start Trial
Uswm	CORGARD	nadolol	TABLET;ORAL	018063-005	Oct 28, 1986	3,935,267	⤷ Start Trial
Uswm	CORGARD	nadolol	TABLET;ORAL	018063-001	Approved Prior to Jan 1, 1982	3,935,267	⤷ Start Trial
Uswm	CORGARD	nadolol	TABLET;ORAL	018063-002	Approved Prior to Jan 1, 1982	3,935,267	⤷ Start Trial
Uswm	CORGARD	nadolol	TABLET;ORAL	018063-004	Approved Prior to Jan 1, 1982	3,982,021	⤷ Start Trial
Uswm	CORGARD	nadolol	TABLET;ORAL	018063-001	Approved Prior to Jan 1, 1982	3,982,021	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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Country	Patent Number	Estimated Expiration
Japan	2018507910	⤷ Start Trial
Hong Kong	1248133	⤷ Start Trial
European Patent Office	3256117	⤷ Start Trial
World Intellectual Property Organization (WIPO)	2016130918	⤷ Start Trial
Canada	2976106	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2701720	23C1000	France	⤷ Start Trial	PRODUCT NAME: MELPHALAN FLUFENAMIDE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, TELS QUE LE CHLORHYDRATE; REGISTRATION NO/DATE: EU/1/22/1669 20220818
2701720	202240050	Slovenia	⤷ Start Trial	PRODUCT NAME: MELPHALAN FLUFENAMIDE HYDROCHLORIDE; NATIONAL AUTHORISATION NUMBER: EU/1/22/1669/001; DATE OF NATIONAL AUTHORISATION: 20220817; AUTHORITY FOR NATIONAL AUTHORISATION: EU
2701720	SPC/GB23/004	United Kingdom	⤷ Start Trial	PRODUCT NAME: MELPHALAN FLUFENAMIDE HYDROCHLORIDE; REGISTERED: UK EU/1/22/1669/001(NI) 20220818; UK MORE ON HISTORY TAB 20220818
2701720	CR 2022 00054	Denmark	⤷ Start Trial	PRODUCT NAME: MELPHALAN FLUFENAMIDE HYDROCHLORIDE; REG. NO/DATE: EU/1/22/1669 20220818
2701720	3/2023	Austria	⤷ Start Trial	PRODUCT NAME: MELPHALANFLUFENAMID-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/22/1669 (MITTEILUNG) 20220818
2701720	122023000007	Germany	⤷ Start Trial	PRODUCT NAME: MELPHALANFLUFENAMID HYDROCHLORID; REGISTRATION NO/DATE: EU/1/22/1669 20220817
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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