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Dow

Last Updated: December 15, 2019

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Sapropterin dihydrochloride - Generic Drug Details

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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-seven patent family members in twenty-four countries.

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

Generic filers with tentative approvals for SAPROPTERIN DIHYDROCHLORIDE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial100MGTABLET;ORAL
  Start Trial  Start Trial100MG/PACKETPOWDER FOR ORAL SOLUTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Paragraph IV (Patent) Challenges for SAPROPTERIN DIHYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
KUVAN POWDER;ORAL sapropterin dihydrochloride 205065 2017-02-23
KUVAN POWDER;ORAL sapropterin dihydrochloride 205065 2015-11-09
KUVAN TABLET;ORAL sapropterin dihydrochloride 022181 2014-06-05

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
Par Pharm Inc SAPROPTERIN DIHYDROCHLORIDE sapropterin dihydrochloride POWDER;ORAL 207207-001 Aug 20, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Biomarin Pharm KUVAN sapropterin dihydrochloride TABLET;ORAL 022181-001 Dec 13, 2007 RX Yes Yes   Start Trial   Start Trial   Start Trial
Biomarin Pharm KUVAN sapropterin dihydrochloride TABLET;ORAL 022181-001 Dec 13, 2007 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Biomarin Pharm KUVAN sapropterin dihydrochloride POWDER;ORAL 205065-002 Oct 27, 2015 RX Yes No   Start Trial   Start Trial Y   Start Trial
Biomarin Pharm KUVAN sapropterin dihydrochloride POWDER;ORAL 205065-002 Oct 27, 2015 RX Yes No   Start Trial   Start Trial   Start Trial
Biomarin Pharm KUVAN sapropterin dihydrochloride POWDER;ORAL 205065-001 Dec 19, 2013 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Par Pharm Inc SAPROPTERIN DIHYDROCHLORIDE sapropterin dihydrochloride TABLET;ORAL 207200-001 May 10, 2019 DISCN No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

McKesson
Merck
Mallinckrodt
Johnson and Johnson
Medtronic
Dow

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