BIOMARIN PHARM Company Profile

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BIOMARIN PHARM has three approved drugs.

There are sixteen US patents protecting BIOMARIN PHARM drugs.

There are one hundred and sixty-nine patent family members on BIOMARIN PHARM drugs in thirty-one countries and nine supplementary protection certificates in nine 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
Biomarin Pharm	KUVAN	sapropterin dihydrochloride	POWDER;ORAL	205065-002	Oct 27, 2015	AB	RX	Yes	No	8,067,416*PED	⤷ Sign Up			Y	⤷ Sign Up
Biomarin Pharm	KUVAN	sapropterin dihydrochloride	TABLET;ORAL	022181-001	Dec 13, 2007	AB	RX	Yes	Yes	7,727,987*PED	⤷ Sign Up			Y	⤷ Sign Up
Biomarin Pharm	KUVAN	sapropterin dihydrochloride	TABLET;ORAL	022181-001	Dec 13, 2007	AB	RX	Yes	Yes	RE43797*PED	⤷ Sign Up			Y	⤷ Sign Up
Biomarin Pharm	KUVAN	sapropterin dihydrochloride	TABLET;ORAL	022181-001	Dec 13, 2007	AB	RX	Yes	Yes	7,566,714*PED	⤷ Sign Up			Y	⤷ Sign Up
Biomarin Pharm	VOXZOGO	vosoritide	POWDER;SUBCUTANEOUS	214938-002	Nov 19, 2021		RX	Yes	Yes		⤷ Sign Up				⤷ Sign Up
Biomarin Pharm	VOXZOGO	vosoritide	POWDER;SUBCUTANEOUS	214938-002	Nov 19, 2021		RX	Yes	Yes		⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ Subscribe	Powder for Oral Solution	100 mg per packet	➤ Subscribe	2015-11-09
➤ Subscribe	Tablets	100 mg	➤ Subscribe	2014-05-30
➤ Subscribe	Powder for Oral Solution	500 mg/packet	➤ Subscribe	2016-12-20

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2432489	C202230004	Spain	⤷ Sign Up	PRODUCT NAME: VOSORITIDE; NATIONAL AUTHORISATION NUMBER: EU/1/21/1577; DATE OF AUTHORISATION: 20210826; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/21/1577; DATE OF FIRST AUTHORISATION IN EEA: 20210826
2432489	122022000008	Germany	⤷ Sign Up	PRODUCT NAME: VOSORITID IN ALLEN DURCH DAS GRUNDPATENT GESCHUETZTEN FORMEN; REGISTRATION NO/DATE: EU/1/21/1577 20210826
2432489	LUC00248	Luxembourg	⤷ Sign Up	PRODUCT NAME: VOSORITIDE SOUS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/21/1577 20210901
2432489	2022C/503	Belgium	⤷ Sign Up	PRODUCT NAME: VOSORITIDE SOUS TOUTES SES FORMES PROTEGEES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/21/1577 20210901
2432489	CA 2022 00004	Denmark	⤷ Sign Up	PRODUCT NAME: VOSORITIDE IN ALL FORMS; REG. NO/DATE: EU/1/21/1577 20210901
2432489	301162	Netherlands	⤷ Sign Up	PRODUCT NAME: VOSORITIDE IN IEDERE VORM ZOALS BESCHERMD DOOR HET BASISOCTROOI; REGISTRATION NO/DATE: EU/1/21/1577 20210901
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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