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Last Updated: December 7, 2022

Sapropterin dihydrochloride - Generic Drug Details


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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 fifteen patent family members in twenty-seven countries.

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

Drug Prices for sapropterin dihydrochloride

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Recent Clinical Trials for sapropterin dihydrochloride

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SponsorPhase
West China HospitalPhase 1
University of PittsburghPhase 1/Phase 2
Ira FoxPhase 1/Phase 2

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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
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
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
Biomarin Pharm KUVAN sapropterin dihydrochloride POWDER;ORAL 205065-002 Oct 27, 2015 AB RX Yes No See Plans and Pricing See Plans and Pricing Y 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
Israel 201101 טטרהידרוביופטרין לשימוש בטיפול בהיפרפנילאלנינמיה על ידי מתן פומי מ-5 עד 20 דקות אחרי ארוחה (Tetrahydrobiopterin for use in treating hyperphenylalaninemia by oral administration 5-20 minutes after a meal) See Plans and Pricing
Portugal 3138566 See Plans and Pricing
Slovenia 3138566 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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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.