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VALCYTE Drug Profile

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When do Valcyte patents expire, and what generic alternatives are available?

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 fifteen drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the valganciclovir hydrochloride profile page.

Summary for VALCYTE

International Patents:	35
US Patents:	2
Applicants:	1
NDAs:	2
Suppliers / Packagers:	1
Bulk Api Vendors:	50
Clinical Trials:	37
Patent Applications:	135
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VALCYTE
DailyMed Link:	VALCYTE at DailyMed

Pharmacology for VALCYTE

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

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

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

Paragraph IV (Patent) Challenges for VALCYTE

Drugname	Dosage	Strength	RLD	Submissiondate
	For Oral Solution	50 mg/mL		2011-03-21
	Tablets	450 mg		2005-12-27

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International Patents for VALCYTE

Country	Document Number	Estimated Expiration
South Korea	20090086469
Russian Federation	2009126616
Morocco	31280
Peru	15782008

Supplementary Protection Certificates for VALCYTE

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C0003	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
00071	Netherlands		PRODUCT NAME: VALGANCICLOVIR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; REGISTRATION NO/DATE: RVG 25992 20010920
C/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
02/028	Ireland		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