Get our Free Patent Expiration Newsletter

Serving leading biopharmaceutical companies globally:

Moodys
Johnson and Johnson
Express Scripts
Baxter
Boehringer Ingelheim
Colorcon

Last Updated: October 14, 2019

DrugPatentWatch Database Preview

Sapropterin dihydrochloride - Generic Drug Details

See Plans and Pricing

« Back to Dashboard

What are the generic sources for sapropterin dihydrochloride and what is the scope of freedom to operate?

Sapropterin dihydrochloride is the generic ingredient in two branded drugs marketed by Biomarin Pharm and Par Pharm Inc, and is included in five NDAs. There are eleven patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Sapropterin dihydrochloride has eighty-six patent family members in twenty-four countries.

There are three drug master file entries for sapropterin dihydrochloride. One supplier is listed for this compound.

Recent Clinical Trials for sapropterin dihydrochloride

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Censa Pharmaceuticals, Inc.Phase 1/Phase 2
Merck KGaAPhase 2
BioMarin PharmaceuticalPhase 4

See all sapropterin dihydrochloride clinical trials

Recent Litigation for sapropterin dihydrochloride

Identify potential future generic entrants

District Court Litigation
Case NameDate
BIOMARIN PHARMACEUTICAL INC. v. PAR PHARMACEUTICAL, INC.2015-03-06

See all sapropterin dihydrochloride litigation

US Patents and Regulatory Information for sapropterin dihydrochloride

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   See Pricing   See Pricing Y   See Pricing
Biomarin Pharm KUVAN sapropterin dihydrochloride TABLET;ORAL 022181-001 Dec 13, 2007 RX Yes Yes   See Pricing   See Pricing Y   See Pricing
Par Pharm Inc SAPROPTERIN DIHYDROCHLORIDE sapropterin dihydrochloride POWDER;ORAL 210027-001 Aug 20, 2019 AB RX No No   See Pricing   See Pricing   See Pricing
Biomarin Pharm KUVAN sapropterin dihydrochloride POWDER;ORAL 205065-002 Oct 27, 2015 AB RX Yes No   See Pricing   See Pricing Y   See Pricing
Biomarin Pharm KUVAN sapropterin dihydrochloride TABLET;ORAL 022181-001 Dec 13, 2007 RX Yes Yes   See Pricing   See Pricing Y   See Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Harvard Business School
Baxter
Johnson and Johnson
Medtronic
McKesson
Moodys

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.