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Last Updated: November 22, 2024

Biomarin Pharm Company Profile


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Summary for Biomarin Pharm
International Patents:169
US Patents:16
Tradenames:2
Ingredients:2
NDAs:3

Drugs and US Patents for Biomarin Pharm

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 9,216,178*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 VOXZOGO vosoritide POWDER;SUBCUTANEOUS 214938-003 Nov 19, 2021 RX Yes Yes 9,907,834 ⤷  Sign Up Y ⤷  Sign Up
Biomarin Pharm KUVAN sapropterin dihydrochloride TABLET;ORAL 022181-001 Dec 13, 2007 AB RX Yes Yes 8,003,126*PED ⤷  Sign Up Y ⤷  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
Paragraph IV (Patent) Challenges for BIOMARIN PHARM drugs
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

Supplementary Protection Certificates for Biomarin Pharm Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 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 C20220003 00351 Estonia ⤷  Sign Up PRODUCT NAME: VOSORITIID;REG NO/DATE: EU/1/21/1577 01.09.2021
2432489 301162 Netherlands ⤷  Sign Up PRODUCT NAME: VOSORITIDE IN IEDERE VORM ZOALS BESCHERMD DOOR HET BASISOCTROOI; REGISTRATION NO/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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.