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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-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.

US ANDA Litigation and Generic Entry Outlook for Valcyte

A generic version of VALCYTE was approved as valganciclovir hydrochloride by DR REDDYS LABS LTD on November 4^th, 2014.

Summary for VALCYTE

International Patents:	36
US Patents:	2
Applicants:	1
NDAs:	2
Suppliers / Packagers:	1
Bulk Api Vendors:	63
Clinical Trials:	40
Patent Applications:	160
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for VALCYTE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VALCYTE
DailyMed Link:	VALCYTE at DailyMed

See drug prices for VALCYTE

Recent Clinical Trials for VALCYTE

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

Sponsor	Phase
Karolinska University Hospital	Phase 2
Cecilia Soderberg-Naucler	Phase 2
Karolinska Institutet	Phase 2

See all VALCYTE clinical trials

Recent Litigation for VALCYTE

Identify potential future generic entrants

District Court Litigation

Case Name	Date
Hoffmann-La Roche Inc. v. Airis Pharma Private Limited	2017-10-13
Genentech, Inc. v. Sandoz Inc.	2011-04-20
Roche Palo Alto LLC v. Endo Pharmaceuticals Inc.	2010-03-31

See all VALCYTE litigation

Pharmacology for VALCYTE

Drug Class	Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor Nucleoside Analog Antiviral
Mechanism of Action	DNA Polymerase Inhibitors

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			Y
Hoffmann La Roche	VALCYTE	valganciclovir hydrochloride	FOR SOLUTION;ORAL	022257-001	Aug 28, 2009	AB	RX	Yes	Yes			Y
Hoffmann La Roche	VALCYTE	valganciclovir hydrochloride	TABLET;ORAL	021304-001	Mar 29, 2001	AB	RX	Yes	Yes

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
Hoffmann La Roche	VALCYTE	valganciclovir hydrochloride	TABLET;ORAL	021304-001	Mar 29, 2001

International Patents for VALCYTE

Country	Patent Number	Estimated Expiration
Germany	694547
European Patent Office	0694547
Australia	2007332640
World Intellectual Property Organization (WIPO)	2008071573
Greece	3030678
Israel	198854
Japan	H0841061

Supplementary Protection Certificates for VALCYTE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0694547	SPC028/2002	Ireland		SPC028/2002: 20040929, EXPIRES: 20160919
0694547	CA 2002 00021	Denmark
0694547	03C0003	France		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		PRODUCT NAME:VALGANCIKLOVIR
0694547	91136	Luxembourg		91136, EXPIRES: 20160920
0694547	C300071	Netherlands		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		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