Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Fish and Richardson
Cerilliant
Dow
Cipla
Cantor Fitzgerald
Argus Health
Healthtrust
QuintilesIMS

Generated: July 17, 2018

DrugPatentWatch Database Preview

Biomarin Pharm Company Profile

« Back to Dashboard

What is the competitive landscape for BIOMARIN PHARM, and what generic alternatives to BIOMARIN PHARM drugs are available?

BIOMARIN PHARM has two approved drugs.

There are eleven US patents protecting BIOMARIN PHARM drugs.

There are seventy-nine patent family members on BIOMARIN PHARM drugs in twenty-four countries.

Summary for Biomarin Pharm
International Patents:79
US Patents:11
Tradenames:1
Ingredients:1
NDAs:2
Patent Litigation for Biomarin Pharm: See patent lawsuits for Biomarin Pharm

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 205065-001 Dec 19, 2013 RX Yes Yes 9,216,178 ➤ Sign Up Y ➤ Sign Up
Biomarin Pharm KUVAN sapropterin dihydrochloride POWDER;ORAL 205065-002 Oct 27, 2015 RX Yes No 8,067,416*PED ➤ Sign Up Y ➤ Sign Up
Biomarin Pharm KUVAN sapropterin dihydrochloride TABLET;ORAL 022181-001 Dec 13, 2007 RX Yes Yes 7,947,681*PED ➤ Sign Up Y ➤ Sign Up
Biomarin Pharm KUVAN sapropterin dihydrochloride POWDER;ORAL 205065-002 Oct 27, 2015 RX Yes No 9,433,624 ➤ 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

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

Paragraph IV (Patent) Challenges for BIOMARIN PHARM drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Tablets 100 mg ➤ Subscribe 2014-05-30
➤ Subscribe Powder for Oral Solution 500 mg/packet ➤ Subscribe 2016-12-20
➤ Subscribe Powder for Oral Solution 100 mg per packet ➤ Subscribe 2015-11-09

Non-Orange Book US Patents for Biomarin Pharm

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,475,360 Method for dynamically providing scroll indicators ➤ Sign Up
8,324,210 Pterin analogs ➤ Sign Up
8,344,139 Process for preparing crystalline polymorphic forms of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride ➤ Sign Up
7,601,717 Pterin analogs ➤ Sign Up
Patent No. Title Estimated Patent Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Federal Trade Commission
McKesson
Dow
Covington
Chubb
Chinese Patent Office
Boehringer Ingelheim
Johnson and Johnson

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 verifification 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.