VALCYTE Drug Patent Profile

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. Twenty-one suppliers are listed for this compound. Additional details are available on the valganciclovir hydrochloride profile page.

DrugPatentWatch^® 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
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	41
Patent Applications:	214
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for VALCYTE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VALCYTE
What excipients (inactive ingredients) are in VALCYTE?	VALCYTE excipients list
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
Viracta Therapeutics, Inc.	Phase 1/Phase 2
Cecilia Soderberg-Naucler	Phase 2
Karolinska University Hospital	Phase 2

See all VALCYTE clinical trials

Pharmacology for VALCYTE

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

Anatomical Therapeutic Chemical (ATC) Classes for VALCYTE

J05AB	Nucleosides and nucleotides excl. reverse transcriptase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

J05AB	Nucleosides and nucleotides excl. reverse transcriptase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

S01AD	Antivirals
S01A	ANTIINFECTIVES
S01	OPHTHALMOLOGICALS
S	Sensory organs

Paragraph IV (Patent) Challenges for VALCYTE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VALCYTE	for Oral Solution	valganciclovir hydrochloride	50 mg/mL	022257	1	2011-03-21
VALCYTE	Tablets	valganciclovir hydrochloride	450 mg	021304	1	2005-12-27

US Patents and Regulatory Information for VALCYTE

VALCYTE is protected by two US patents.

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

International Patents for VALCYTE

See the table below for patents covering VALCYTE around the world.

Country	Patent Number	Title	Estimated Expiration
China	1045089
Japan	H0841061	2-(2-AMINO-1,6-DIHYDRO-6-OXOPURIN-9-YL)METHOXY-1, 3-PROPANEDIOL DERIVATIVE
Poland	2101733
Portugal	2101733
Ukraine	93599	ПОРОШКОПОДІБНИЙ ПРЕПАРАТ ВАЛГАНЦИКЛОВІРУ[Порошкообразный препарат валганцикловира (powder valgancyclovir preparation)

Supplementary Protection Certificates for VALCYTE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0694547	0290023-1	Sweden		PRODUCT NAME:VALGANCIKLOVIR
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	91136	Luxembourg		91136, EXPIRES: 20160920
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
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