Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Merck
Express Scripts
Baxter
Dow
Medtronic

Last Updated: October 15, 2019

DrugPatentWatch Database Preview

KUVAN Drug Profile

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Which patents cover Kuvan, and when can generic versions of Kuvan launch?

Kuvan is a drug marketed by Biomarin Pharm and is included in two NDAs. There are eleven patents protecting this drug and three Paragraph IV challenges.

This drug has eighty-six patent family members in twenty-four countries.

The generic ingredient in KUVAN is sapropterin dihydrochloride. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sapropterin dihydrochloride profile page.

Drug patent expirations by year for KUVAN
Drug Prices for KUVAN

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Recent Litigation for KUVAN

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

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US Patents and Regulatory Information for KUVAN

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 205065-001 Dec 19, 2013 AB RX Yes Yes   See Pricing   See Pricing   See Pricing
Biomarin Pharm KUVAN sapropterin dihydrochloride TABLET;ORAL 022181-001 Dec 13, 2007 RX Yes Yes   See Pricing   See Pricing Y   See Pricing
Biomarin Pharm KUVAN sapropterin dihydrochloride POWDER;ORAL 205065-002 Oct 27, 2015 AB RX Yes No   See Pricing   See Pricing   See Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration
Paragraph IV (Patent) Challenges for KUVAN
Drugname Dosage Strength RLD Date
➤ Subscribe Powder for Oral Solution 500 mg/packet ➤ Subscribe   See Pricing
➤ Subscribe Powder for Oral Solution 100 mg per packet ➤ Subscribe   See Pricing
➤ Subscribe Tablets 100 mg ➤ Subscribe   See Pricing

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Serving leading biopharmaceutical companies globally:

Colorcon
Mallinckrodt
McKesson
McKinsey
Harvard Business School
Medtronic

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.