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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.

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.

Summary for KUVAN

US Patents:	11
Applicants:	1
NDAs:	2
Suppliers / Packagers:	1
Bulk Api Vendors:	65
Patent Applications:	168
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

Generic Entry Opportunity Date for KUVAN

NDA:

205065

Dosage:

POWDER;ORAL

NDA:

022181

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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,1'R,2'S)-5,6,7,8 TETRAHYDROBIOPTERIN

(6R,S)-5,6,7,8-TETRAHYDRO-L-BIOPTERIN 2HCL

(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-tetrahydro-1H-pteridin-4-one

(6R)-2-amino-6-[(1R,2S)-1,2-dihydroxypropyl]-5,6,7,8-tetrahydro-1H-pteridin-4-one 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]-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 Dihydrochloride

(6R)-5,6,7,8-Tetrahydrobiopterin

(6R)-5,6,7,8-Tetrahydrobiopterin dihydrochloride

(6R)-BH4

(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

(R)-2-Amino-6-((1R,2S)-1,2-dihydroxypropyl)-5,6,7,8-tetrahydropteridin-4(3H)-onedihydrochloride

129443-84-1

2-Amino-6-(1,2-dihydroxypropyl)-5,6,7,8-tetrahydoro-4(1H)-pteridinone

2-amino-6-(1,2-dihydroxypropyl)-5,6,7,8-tetrahydro-1H-pteridin-4-one

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

5,6,7,8-tetra-H-biopterin

5,6,7,8-tetrahydro-L-erythrobiopterin

5,6,7,8-tetrahydrobiopterin

5,6,7,8-tetrahydrodictyopterin

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-L-erythro-5,6,7,8-tetrahydrobiopterin

6R-Tetrahydrobiopterin

7-tetrahydrobiopterin

79493-88-2

90687-77-7

AC1L2BG0

AC1LCS48

AJ-64209

AJ-64210

AK-93996

AKOS030231420

AN-37981

ANW-53224

AX8018900

BCBcMAP01_000204

BDBM50373697

BH4

Biobuden

BioMarin T 1401

Biopten

Biopten (TN)

Biopterin, 5,6,7,8-tetrahydro-

Bipten

bmse000911

BPH4

C00272

CAS-69056-38-8

CHEBI:32120

CHEBI:59560

CHEMBL1201774

CHEMBL1201775

CHEMBL1515624

CS-5740

CTK8B6290

D01798

D08505

D0F9XO

D0Q9YT

D0S2IQ

Dapropterin

Dapropterin dihydrochloride

DAPROTERIN

DB00360

DSSTox_CID_20620

DSSTox_GSID_40620

DSSTox_RID_79515

DTXSID0040620

DTXSID1041138

EGX657432I

FNKQXYHWGSIFBK-RPDRRWSUSA-N

FT-0653813

FT-0674967

FT-0700530

GTPL5276

HE023397

HE119041

HE330552

HY-A0124A

KS-00001853

Kuvan (TN)

L-erythro-tetrahydrobiopterin

MLS001332479

MLS002153148

MLS006010665

MolPort-003-959-732

NCGC00160393-01

Phenoptin

phenylalanine hydroxylase cofactor

R-THBP

RG277LF5B3

Sapropterin

Sapropterin (dihydrochloride)

Sapropterin (INN)

Sapropterin (TN)

Sapropterin [EMA EPAR]

Sapropterin [INN]

Sapropterin [MI]

Sapropterin [VANDF]

sapropterin 2HCl

Sapropterin DiHCl

Sapropterin dihydrochloride

Sapropterin dihydrochloride (USAN)

Sapropterin dihydrochloride [USAN]

Sapropterin HCl

SAPROPTERIN HYDROCHLORIDE

Sapropterin hydrochloride (JAN)

Sapropterina

Sapropterina [INN-Spanish]

Sapropterinum

Sapropterinum [INN-Latin]

SCHEMBL1070420

SCHEMBL258544

SCHEMBL258963

Shiratori SN 0588

SMP1_000285

SMR000326922

SMR004701650

SUN 0588

SUN-0588

SUN-0588 (SHIRATORI)

T-1401

T-1401 (Biomarin)

T1401 (BIOMARIN)

tetra-H-biopterin

tetra-hydro-biopterin

tetrahydro-6-biopterin

tetrahydro-l-biopterin

tetrahydrobiopterin

tetrahydrobiopterin (THB)

Tetrahydrobiopterin [WHO-DD]

Tetrahydrobiopterin dihydrochloride

THB

Tox21_111782

UNII-EGX657432I

UNII-RG277LF5B3

W-203341

W-203533

ZINC13585233

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		RX	Yes	Yes
Biomarin Pharm	KUVAN	sapropterin dihydrochloride	TABLET;ORAL	022181-001	Dec 13, 2007		RX	Yes	Yes					Y
Biomarin Pharm	KUVAN	sapropterin dihydrochloride	POWDER;ORAL	205065-002	Oct 27, 2015		RX	Yes	No
Biomarin Pharm	KUVAN	sapropterin dihydrochloride	POWDER;ORAL	205065-001	Dec 19, 2013		RX	Yes	Yes					Y
Biomarin Pharm	KUVAN	sapropterin dihydrochloride	POWDER;ORAL	205065-002	Oct 27, 2015		RX	Yes	No					Y
Biomarin Pharm	KUVAN	sapropterin dihydrochloride	TABLET;ORAL	022181-001	Dec 13, 2007		RX	Yes	Yes					Y

Paragraph IV (Patent) Challenges for KUVAN

Drugname	Dosage	Strength	RLD	Date
	Powder for Oral Solution	500 mg/packet
	Powder for Oral Solution	100 mg per packet
	Tablets	100 mg

International Patents for KUVAN

Country	Document Number	Estimated Expiration
Brazil	PI0821970
Canada	2678165
World Intellectual Property Organization (WIPO)	2009088530
Australia	2004291149
Russian Federation	2006121341
European Patent Office	1687308