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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Citi
Mallinckrodt
Fish and Richardson
McKesson
Chubb
Covington
QuintilesIMS
Queensland Health

Generated: December 12, 2018

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VALCYTE Drug Profile

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When do Valcyte patents expire, and when can generic versions of Valcyte launch?

Valcyte is a drug marketed by Hoffmann La Roche and is included in two NDAs. There are two patents protecting this drug and two Paragraph IV challenges.

This drug has thirty-five patent family members in thirty countries.

The generic ingredient in VALCYTE is valganciclovir hydrochloride. There are seventeen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the valganciclovir hydrochloride profile page.

Drug patent expirations by year for VALCYTE
Synonyms for VALCYTE
(S)-Valganciclovir Hydrochloride
[2-[(2-amino-6-oxo-3H-purin-9-yl)methoxy]-3-hydroxy-propyl] (2S)-2-amino-3-methyl-butanoate hydrochloride
[2-[(2-amino-6-oxo-3H-purin-9-yl)methoxy]-3-hydroxypropyl] (2S)-2-amino-3-methylbutanoate hydrochloride
175865-59-5
2-[(2-Amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]-3-hydroxypropyl Ester L-Valine Hydrochloride
2-[(2-amino-6-oxo-6,9-dihydro-3H-purin-9-yl)methoxy]-3-hydroxypropyl (2S)-2-amino-3-methylbutanoate hydrochloride hydrate
865V595
AC-7501
AC1L3802
ACT02670
AK-59963
AKOS015963325
AKOS030241609
AN-8918
BC215809
BS-1015
C14H22N6O5.HCl
C14H23ClN6O5
CAS-175865-59-5
CCG-213225
CHEMBL1200454
CS-1755
CTK8F1149
D03256
DSSTox_CID_26784
DSSTox_GSID_46784
DSSTox_RID_81902
DTXSID9046784
EBD4420
FT-0631198
HY-A0032A
J-011142
KB-278124
KS-00000XN5
L-Valine, 2-((2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy)-3-hydroxypropyl ester, monohydrochloride
L-Valine, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]-3-hydroxypropyl ester, hydrochloride (1:1)
L-Valine, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]-3-hydroxypropyl ester, monohydrochloride hydrate
L-Valine, ester with 9-((2-hydroxy-1-(hydroxymethyl)ethoxy)methyl)guanine, monohydrochloride
L-Valine,2[(amino-1,6-dihydro-6-oxo-9H-purin-9-y1)methoxy]-3-hydroxypropyl ester, monohydrochloride
LS-173676
MFCD08460118
MLS003876616
MolPort-005-938-316
MolPort-028-751-165
NCGC00168779-01
NSC-760349
NSC760349
Pharmakon1600-01503870
R-127
RG-127
RO 107-9070/194
Ro-10-79070/194
Ro-1079070/194
Ro107-9070/194
RS 079070-194
RS-079070-194
RS-79070
RS-79070-194
SC-15265
SCHEMBL23225
SMR002533167
TA-9070
Tox21_112640
Valcyt
Valcyte (TN)
Valganciclovir (hydrochloride)
Valganciclovir HCl
Valganciclovir hydrochloride
Valganciclovir hydrochloride (JAN/USAN)
Valganciclovir hydrochloride [USAN:USP]
Valixa
ZORWARFPXPVJLW-MTFPJWTKSA-N

US Patents and Regulatory Information for VALCYTE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hoffmann La Roche VALCYTE valganciclovir hydrochloride FOR SOLUTION;ORAL 022257-001 Aug 28, 2009 AB RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Hoffmann La Roche VALCYTE valganciclovir hydrochloride FOR SOLUTION;ORAL 022257-001 Aug 28, 2009 AB RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Hoffmann La Roche VALCYTE valganciclovir hydrochloride FOR SOLUTION;ORAL 022257-001 Aug 28, 2009 AB RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
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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Expired US Patents for VALCYTE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Hoffmann La Roche VALCYTE valganciclovir hydrochloride FOR SOLUTION;ORAL 022257-001 Aug 28, 2009 ➤ Sign Up ➤ Sign Up
Hoffmann La Roche VALCYTE valganciclovir hydrochloride TABLET;ORAL 021304-001 Mar 29, 2001 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for VALCYTE
Drugname Dosage Strength RLD Date
➤ Subscribe For Oral Solution 50 mg/mL ➤ Subscribe ➤ Sign Up
➤ Subscribe Tablets 450 mg ➤ Subscribe ➤ Sign Up

Supplementary Protection Certificates for VALCYTE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00071 Netherlands ➤ Sign Up PRODUCT NAME: VALGANCICLOVIR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; REGISTRATION NO/DATE: RVG 25992 20010920
C0003 France ➤ Sign Up PRODUCT NAME: VALGANCICLOVIR AINSI QUE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES ET EN PARTICULIER LE CHLORHYDRATE; NAT. REGISTRATION NO/DATE: NL 27380 20021016; FIRST REGISTRATION: NL - RVG 25 992 20010920
C/GB02/027 United Kingdom ➤ Sign Up PRODUCT NAME: 2-(2-AMINO-1,6-DIHYDRO-6-OXO-PURIN-9-YL)-METHOXY-3-HYDROXY-1-PROPANYL-L-VALINATE HYDROCHLORIDE (VALGANCICLOVIR HYDROCHLORIDE); REGISTERED: NL RVG 25992 20010920; UK PL 00031/0599 20020425
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
Daiichi Sankyo
McKinsey
Fish and Richardson
Accenture
Dow
Express Scripts
Citi
UBS

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