Time limited offer for new users ▶ Get up to 3 months free

Serving leading biopharmaceutical companies globally:

Baxter
Johnson and Johnson
Harvard Business School
Dow
McKesson
Boehringer Ingelheim

Last Updated: January 30, 2023

Sapropterin dihydrochloride - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions


What are the generic drug 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, Annora Pharma, Dr Reddys, and Par Pharm Inc, and is included in ten NDAs. There are ten patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Sapropterin dihydrochloride has one hundred and fourteen patent family members in twenty-six countries.

There is one drug master file entry for sapropterin dihydrochloride. Five suppliers are listed for this compound.

Drug Prices for sapropterin dihydrochloride

See drug prices for sapropterin dihydrochloride

Recent Clinical Trials for sapropterin dihydrochloride

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

SponsorPhase
West China HospitalPhase 1
Ira FoxPhase 1/Phase 2
West China Second University HospitalPhase 2

See all sapropterin dihydrochloride clinical trials

Paragraph IV (Patent) Challenges for SAPROPTERIN DIHYDROCHLORIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
KUVAN Powder for Oral Solution sapropterin dihydrochloride 500 mg per packet 205065 1 2017-02-23
KUVAN Powder for Oral Solution sapropterin dihydrochloride 100 mg per packet 205065 1 2015-11-09
KUVAN Tablets sapropterin dihydrochloride 100 mg 022181 1 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 210027-001 Aug 20, 2019 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Biomarin Pharm KUVAN sapropterin dihydrochloride TABLET;ORAL 022181-001 Dec 13, 2007 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Annora Pharma SAPROPTERIN DIHYDROCHLORIDE sapropterin dihydrochloride POWDER;ORAL 215420-001 Aug 18, 2022 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Annora Pharma SAPROPTERIN DIHYDROCHLORIDE sapropterin dihydrochloride TABLET;ORAL 215534-001 Aug 23, 2022 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Biomarin Pharm KUVAN sapropterin dihydrochloride POWDER;ORAL 205065-001 Dec 19, 2013 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Dr Reddys SAPROPTERIN DIHYDROCHLORIDE sapropterin dihydrochloride POWDER;ORAL 209452-001 Mar 30, 2021 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for sapropterin dihydrochloride

Country Patent Number Title Estimated Expiration
Russian Federation 2009141618 КОМПОЗИЦИИ ТЕТРАГИДРОБИОПТЕРИНА И СПОСОБЫ ЕГО КОЛИЧЕСТВЕННОЙ ОЦЕНКИ See Plans and Pricing
World Intellectual Property Organization (WIPO) 2006055511 See Plans and Pricing
European Patent Office 3461503 PROCÉDÉS D'ADMINISTRATION DE LA TÉTRAHYDROBIOPTÉRINE, COMPOSITIONS ASSOCIÉES ET PROCÉDÉS DE MESURE (METHODS OF ADMINISTERING TETRAHYDROBIOPTERIN, ASSOCIATED COMPOSITIONS, AND METHODS OF MEASURING) See Plans and Pricing
Spain 2397746 See Plans and Pricing
Japan 2010523708 See Plans and Pricing
China 1905863 Methods and compositions for the treatment of metabolic disorders See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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

Serving leading biopharmaceutical companies globally:

Mallinckrodt
McKinsey
Boehringer Ingelheim
AstraZeneca
Johnson and Johnson
Express Scripts

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.