➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

McKesson
Dow
Merck
McKinsey
Mallinckrodt
Harvard Business School

Last Updated: June 5, 2020

DrugPatentWatch Database Preview

VALCYTE Drug Profile


Email this page to a colleague

» See Plans and Pricing

« Back to Dashboard

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-six patent family members in thirty-one countries.

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

Drug patent expirations by year for VALCYTE
Drug Prices for VALCYTE

See drug prices for VALCYTE

Recent Clinical Trials for VALCYTE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Karolinska University HospitalPhase 2
Cecilia Soderberg-NauclerPhase 2
Karolinska InstitutetPhase 2

See all VALCYTE clinical trials

Recent Litigation for VALCYTE

Identify potential future generic entrants

District Court Litigation
Case NameDate
Hoffmann-La Roche Inc. v. Airis Pharma Private Limited2017-10-13
Genentech, Inc. v. Sandoz Inc.2011-04-20
Roche Palo Alto LLC v. Endo Pharmaceuticals Inc.2010-03-31

See all VALCYTE litigation

Synonyms for VALCYTE
(2S)-2-((2-amino-6-oxo-1H-purin-9(6H)-yl)methoxy)-3-hydroxypropyl 2-amino-3-methylbutanoate hydrochloride
[2-[(2-amino-6-oxo-3H-purin-9-yl)methoxy]-3-hydroxypropyl] (2S)-2-amino-3-methylbutanoate 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-6-oxo-6,9-dihydro-3H-purin-9-yl)methoxy]-3-hydroxypropyl (2S)-2-amino-3-methylbutanoate hydrochloride hydrate
865V595
AC-7501
ACT02670
AKOS015963325
AKOS030241609
BS-1015
C14H22N6O5.HCl
C14H23ClN6O5
CAS-175865-59-5
CCG-213225
CHEMBL1200454
CS-1755
CTK8F1149
Cymeval
D03256
DSSTox_CID_26784
DSSTox_GSID_46784
DSSTox_RID_81902
DTXSID9046784
EBD4420
FT-0631198
HY-A0032A
J-011142
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, 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
MLS003876616
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]
Valganciclovir hydrochloride, 97+%
valganciclovir-hcl
Valixa
ZORWARFPXPVJLW-MTFPJWTKSA-N
Paragraph IV (Patent) Challenges for VALCYTE
Tradename Dosage Ingredient NDA Submissiondate
VALCYTE FOR SOLUTION;ORAL valganciclovir hydrochloride 022257 2011-03-21
VALCYTE TABLET;ORAL valganciclovir hydrochloride 021304 2005-12-27

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   Start Trial   Start Trial Y   Start Trial
Hoffmann La Roche VALCYTE valganciclovir hydrochloride FOR SOLUTION;ORAL 022257-001 Aug 28, 2009 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Hoffmann La Roche VALCYTE valganciclovir hydrochloride TABLET;ORAL 021304-001 Mar 29, 2001 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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   Start Trial   Start Trial
Hoffmann La Roche VALCYTE valganciclovir hydrochloride TABLET;ORAL 021304-001 Mar 29, 2001   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for VALCYTE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0694547 SPC028/2002 Ireland   Start Trial SPC028/2002: 20040929, EXPIRES: 20160919
0694547 CA 2002 00021 Denmark   Start Trial
0694547 03C0003 France   Start 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
0694547 0290023-1 Sweden   Start Trial PRODUCT NAME:VALGANCIKLOVIR
0694547 91136 Luxembourg   Start Trial 91136, EXPIRES: 20160920
0694547 C300071 Netherlands   Start Trial PRODUCT NAME: VALGANCICLOVIR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; REGISTRATION NO/DATE: RVG 25992 20010920
0694547 SPC/GB02/027 United Kingdom   Start 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

McKesson
Dow
Merck
McKinsey
Mallinckrodt
Harvard Business School

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 verification 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.