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KUVAN Drug Profile

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Which patents cover Kuvan, and what generic alternatives are available?

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-nine 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.

US ANDA Litigation and Generic Entry Outlook for Kuvan

A generic version of KUVAN was approved as sapropterin dihydrochloride by PAR PHARM INC on August 20^th, 2019.

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Summary for KUVAN

International Patents:	89
US Patents:	11
Applicants:	1
NDAs:	2
Suppliers / Packagers:	1
Bulk Api Vendors:	71
Patent Applications:	199
Drug Prices:	Drug price information for KUVAN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for KUVAN
DailyMed Link:	KUVAN at DailyMed

Drug patent expirations by year for KUVAN

Recent Litigation for KUVAN

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District Court Litigation

Case Name	Date
BIOMARIN PHARMACEUTICAL INC. v. PAR PHARMACEUTICAL, INC.	2015-03-06

See all KUVAN litigation

Pharmacology for KUVAN

Drug Class	Phenylalanine Hydroxylase Activator
Mechanism of Action	Phenylalanine Hydroxylase Activators Breast Cancer Resistance Protein Inhibitors P-Glycoprotein Inhibitors

Synonyms for KUVAN

(-)-(6R)-2-Amino-6-((1R,2S)-1,2-dihydroxypropyl)-5,6,7,8-tetrahydro-4(3H)-pteridinone
(6beta)-5,6,7,8-Tetrahydro-L-biopterin dihydrochloride
(6R)-2-Amino-6-((1R,2S)-1,2-dihydroxypropyl)-5,6,7,8-tetrahydro-4(1H)-pteridinone
(6R)-2-Amino-6-((1R,2S)-1,2-dihydroxypropyl)-5,6,7,8-tetrahydro-4(1H)-pteridinone dihydrochloride
(6R)-2-Amino-6-((1R,2S)-1,2-dihydroxypropyl)-5,6,7,8-tetrahydropteridin-4(1H)-one
(6R)-2-amino-6-[(1R,2S)-1,2-dihydroxypropyl]-3,4,5,6,7,8-hexahydropteridin-4-one
(6R)-2-amino-6-[(1R,2S)-1,2-dihydroxypropyl]-5,6,7,8-tetrahydropteridin-4(1H)-one
(6R)-2-amino-6-[(1R,2S)-1,2-dihydroxypropyl]-5,6,7,8-tetrahydropteridin-4(1H)-one dihydrochloride
(6R)-2-amino-6-[(1R,2S)-1,2-dihydroxypropyl]-5,6,7,8-tetrahydropteridin-4(3H)-one
(6R)-2-amino-6-[(1R,2S)-1,2-dihydroxypropyl]-5,6,7,8-tetrahydropteridin-4(3H)-one dihydrochloride
(6R)-5,6,7,8-TETRAHYDRO-L-BIOPTERIN
(6R)-5,6,7,8-Tetrahydro-L-biopterin 2HCl
(6R)-5,6,7,8-Tetrahydro-l-biopterin diHCl
(6R)-5,6,7,8-Tetrahydro-L-Biopterin Dihydrochloride
(6R)-5,6,7,8-Tetrahydrobiopterin
(6R)-5,6,7,8-Tetrahydrobiopterin dihydrochloride
(6r)-erythro-5,6,7,8-tet-rahydrobiopterin
(6R)-L-erythro-5,6,7,8-Tetrahydrobiopterin
(6R)-L-erythro-tetrahydrobiopterin
(6R)-Tetrahydrobiopterin
(6R)-tetrahydrobiopterin dihydrochloride
(6R)-Tetrahydrobiopterin hydrochloride
(R)-2-amino-6-((1R,2S)-1,2-dihydroxypropyl)-5,6,7,8-tetrahydropteridin-4(1H)-one
(R)-2-amino-6-((1R,2S)-1,2-dihydroxypropyl)-5,6,7,8-tetrahydropteridin-4(1H)-one dihydrochloride
(R)-2-Amino-6-((1R,2S)-1,2-dihydroxypropyl)-5,6,7,8-tetrahydropteridin-4(3H)-one dihydrochloride
2-amino-6-((1R,2S)-1,2-dihydroxypropyl)-5,6,7,8-tetrahydropteridin-4(3H)-one
2-Amino-6-(1,2-dihydroxypropyl)-5,6,7,8-tetrahydoro-4(1H)-pteridinone
2-Amino-6R-(1R,2S-dihydroxypropyl)-5,6,7,8-tetrahydro-4(1H)-pteridinone
27070-47-9
4(1H)-Pteridinone, (6R)-2-amino-6-((1R,2S)-1,2-dihydroxypropyl)-5,6,7,8-tetrahydro-
4(1H)-Pteridinone, 2-amino-6-[(1R,2S)-1,2-dihydroxypropyl]-5,6,7,8-tetrahydro-, (6r)-
4(1H)-Pteridinone, 5,6,7,8-tetrahydro-2-amino-6-(1,2-dihydroxypropyl)-, dihydrochloride, (6R-(6R(1R,2S*)))-
4(1H)-Pteridinone,2-amino-6-[(1R,2S)-1,2-dihydroxypropyl]-5,6,7,8-tetrahydro
5,6,7,8-tetrahydrobiopterin
56T388
62989-33-7
69056-38-8
69081654-1FB6-4B89-B9B9-823C9887EE36
6R-5,6,7,8-Tetrahydrobiopterin
6R-BH4
6R-L-5,6,7,8-Tetrahydrobiopterin
6R-Tetrahydrobiopterin
AC-30208
AKOS016842774
ANW-53224
AX8018900
BCBcMAP01_000204
BCP03735
BCP09678
BDBM50373697
BH4
Biobuden
BioMarin T 1401
Biopten
Biopten (TN)
Biopterin, 5,6,7,8-tetrahydro-
Bipten
bmse000911
C00272
CAS-69056-38-8
CHEBI:32120
CHEBI:59560
CHEMBL1201774
CHEMBL1201775
CS-5740
CTK8B6290
D01798
D08505
Dapropterin
Dapropterin dihydrochloride
DAPROTERIN
DB00360
DS-018709
DSSTox_CID_20620
DSSTox_GSID_40620
DSSTox_RID_79515
DTXSID0040620
DTXSID1041138
EGX657432I
EX-A2877
FNKQXYHWGSIFBK-RPDRRWSUSA-N
FT-0653813
FT-0674967
FT-0700530
GTPL5276
HY-A0124A
KS-00001853
Kuvan (TN)
L-erythro-tetrahydrobiopterin
NCGC00160393-01
NCGC00485328-01
Phenoptin
Q27114793
R-THBP
RG277LF5B3
s9568
Sapropterin
Sapropterin (dihydrochloride)
Sapropterin (INN)
Sapropterin [EMA EPAR]
Sapropterin [INN]
Sapropterin [MI]
Sapropterin [VANDF]
sapropterin 2HCl
Sapropterin dihydrochloride
Sapropterin dihydrochloride (USAN)
Sapropterin dihydrochloride [USAN]
Sapropterin HCl
SAPROPTERIN HYDROCHLORIDE
Sapropterin hydrochloride (JAN)
Sapropterina
Sapropterina [INN-Spanish]
Sapropterinum
Sapropterinum [INN-Latin]
SCHEMBL258544
SCHEMBL258963
Shiratori SN 0588
SMP1_000285
SUN 0588
SUN-0588
SUN-0588 (SHIRATORI)
T-1401
T-1401 (Biomarin)
T1401
T1401 (BIOMARIN)
tetrahydro-l-biopterin
tetrahydrobiopterin
tetrahydrobiopterin (THB)
Tetrahydrobiopterin [WHO-DD]
Tetrahydrobiopterin dihydrochloride
THB
Tox21_111782
UNII-EGX657432I
UNII-RG277LF5B3
W-203341
W-203533
ZINC13585233

Paragraph IV (Patent) Challenges for KUVAN

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 KUVAN

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Glossary

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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	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				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
Biomarin Pharm	KUVAN	sapropterin dihydrochloride	POWDER;ORAL	205065-002	Oct 27, 2015		RX	Yes	No	Start Trial	Start Trial			Y	Start Trial
>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 KUVAN

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Country	Patent Number	Estimated Expiration
Canada	2711160	Start Trial
European Patent Office	2139485	Start Trial
European Patent Office	1708690	Start Trial
Japan	2012207029	Start Trial
European Patent Office	2545939	Start Trial
>Country	>Patent Number	>Estimated Expiration