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Biomarin Pharm Company Profile

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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.

Summary for Biomarin Pharm

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	TABLET;ORAL	022181-001	Dec 13, 2007		RX	Yes	Yes	7,612,073*PED				Y
Biomarin Pharm	KUVAN	sapropterin dihydrochloride	POWDER;ORAL	205065-002	Oct 27, 2015		RX	Yes	No	7,566,714*PED				Y
Biomarin Pharm	KUVAN	sapropterin dihydrochloride	POWDER;ORAL	205065-002	Oct 27, 2015		RX	Yes	No	7,612,073*PED				Y
Biomarin Pharm	KUVAN	sapropterin dihydrochloride	POWDER;ORAL	205065-002	Oct 27, 2015		RX	Yes	No	8,067,416*PED				Y
Biomarin Pharm	KUVAN	sapropterin dihydrochloride	TABLET;ORAL	022181-001	Dec 13, 2007		RX	Yes	Yes	7,566,462*PED				Y

Paragraph IV (Patent) Challenges for BIOMARIN PHARM drugs

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

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
8,344,139	Process for preparing crystalline polymorphic forms of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride
8,324,210	Pterin analogs
7,601,717	Pterin analogs

International Patents for Biomarin Pharm Drugs

Country	Document Number	Estimated Expiration
Russian Federation	2470642
Malaysia	142120
Japan	2008520574
South Korea	20160064248
European Patent Office	2436379

Similar Applicant Names

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

• Biomarin Pharm
• Biomedcl Res Fdn