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Generated: July 16, 2018

DrugPatentWatch Database Preview

Valganciclovir hydrochloride - Generic Drug Details

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What are the generic drug sources for valganciclovir hydrochloride and what is the scope of valganciclovir hydrochloride patent protection?

Valganciclovir hydrochloride
is the generic ingredient in two branded drugs marketed by Hoffmann La Roche, Actavis Labs Fl Inc, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Endo Pharms Inc, and Hetero Labs Ltd V, and is included in eight NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Valganciclovir hydrochloride has thirty-five patent family members in thirty countries.

There are fifteen drug master file entries for valganciclovir hydrochloride. Twelve suppliers are listed for this compound.
Pharmacology for valganciclovir hydrochloride
Synonyms for valganciclovir hydrochloride
(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
Valcyte (TN)
Valganciclovir (hydrochloride)
Valganciclovir HCl
Valganciclovir hydrochloride (JAN/USAN)
Valganciclovir hydrochloride [USAN:USP]
Valixa
ZORWARFPXPVJLW-MTFPJWTKSA-N

US Patents and Regulatory Information for valganciclovir hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Actavis Labs Fl Inc VALGANCICLOVIR HYDROCHLORIDE valganciclovir hydrochloride FOR SOLUTION;ORAL 205220-001 Jul 18, 2016 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Endo Pharms Inc VALGANCICLOVIR HYDROCHLORIDE valganciclovir hydrochloride TABLET;ORAL 200790-001 Nov 4, 2014 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Aurobindo Pharma Ltd VALGANCICLOVIR HYDROCHLORIDE valganciclovir hydrochloride TABLET;ORAL 204750-001 Mar 31, 2016 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Dr Reddys Labs Ltd VALGANCICLOVIR HYDROCHLORIDE valganciclovir hydrochloride TABLET;ORAL 206876-001 Dec 12, 2017 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ 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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Expired US Patents for valganciclovir hydrochloride

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

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Supplementary Protection Certificates for valganciclovir hydrochloride

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB02/027 United Kingdom ➤ Try a Free Trial 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
C0003 France ➤ Try a Free Trial 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
00071 Netherlands ➤ Try a Free Trial PRODUCT NAME: VALGANCICLOVIR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; REGISTRATION NO/DATE: RVG 25992 20010920
02/028 Ireland ➤ Try a Free Trial PRODUCT NAME: VALGANCICLOVIR (2-(2-AMINO-1,6-DIHYDRO-6-OXO-PURIN-9-YL)- METHOXY-3-HYDROXY-1-PROPANYL-L-VALINATE) AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; NAT REGISTRATION NO/DATE: 50/150/1 20020913; FIRST REGISTRATION NO/DATE: NL 25992 20010920; PAEDIATRIC INVESTIGATION PLAN: P/0220/2013
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Federal Trade Commission
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Healthtrust
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