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Deloitte
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Cerilliant
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Dow
US Department of Justice
Teva
Mallinckrodt

Generated: November 19, 2018

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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.

Drug patent expirations by year for KUVAN
Generic Entry Opportunity Date for KUVAN
Generic Entry Dates for KUVAN*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
POWDER;ORAL
Generic Entry Dates for KUVAN*:
Constraining patent/regulatory exclusivity:
NDA:
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.

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 ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Biomarin Pharm KUVAN sapropterin dihydrochloride TABLET;ORAL 022181-001 Dec 13, 2007 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Biomarin Pharm KUVAN sapropterin dihydrochloride POWDER;ORAL 205065-002 Oct 27, 2015 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Biomarin Pharm KUVAN sapropterin dihydrochloride POWDER;ORAL 205065-001 Dec 19, 2013 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Biomarin Pharm KUVAN sapropterin dihydrochloride POWDER;ORAL 205065-002 Oct 27, 2015 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Biomarin Pharm KUVAN sapropterin dihydrochloride TABLET;ORAL 022181-001 Dec 13, 2007 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Paragraph IV (Patent) Challenges for KUVAN
Drugname Dosage Strength RLD Date
➤ Subscribe Powder for Oral Solution 500 mg/packet ➤ Subscribe ➤ Try a Free Trial
➤ Subscribe Powder for Oral Solution 100 mg per packet ➤ Subscribe ➤ Try a Free Trial
➤ Subscribe Tablets 100 mg ➤ Subscribe ➤ Try a Free Trial

International Patents for KUVAN

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
Farmers Insurance
Cerilliant
Moodys
Argus Health
Dow
US Department of Justice
Teva
Mallinckrodt

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.