Valganciclovir hydrochloride - Generic Drug Details

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What are the generic sources for valganciclovir hydrochloride and what is the scope of freedom to operate?

Valganciclovir hydrochloride is the generic ingredient in two branded drugs marketed by Hoffmann La Roche, Actavis Labs Fl Inc, Ajanta Pharma Ltd, Aurobindo Pharma, Granules, Hetero Labs Ltd V, MSN, Aurobindo Pharma Ltd, Cipla, Dr Reddys, Mylan, and Strides Pharma, and is included in sixteen 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-six patent family members in thirty-one countries.

There are seventeen drug master file entries for valganciclovir hydrochloride. Twenty-two suppliers are listed for this compound.

Summary for valganciclovir hydrochloride

International Patents:	36
US Patents:	2
Tradenames:	2
Applicants:	12
NDAs:	16
Drug Master File Entries:	17
Finished Product Suppliers / Packagers:	22
Raw Ingredient (Bulk) Api Vendors:	81
Clinical Trials:	103
Patent Applications:	303
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for valganciclovir hydrochloride
What excipients (inactive ingredients) are in valganciclovir hydrochloride?	valganciclovir hydrochloride excipients list
DailyMed Link:	valganciclovir hydrochloride at DailyMed

Recent Clinical Trials for valganciclovir hydrochloride

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

Sponsor	Phase
Viracor Eurofins	Phase 2
NYU Langone Health	Phase 2
New York Medical College	Phase 1/Phase 2

See all valganciclovir hydrochloride clinical trials

Pharmacology for valganciclovir hydrochloride

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

Anatomical Therapeutic Chemical (ATC) Classes for valganciclovir hydrochloride

Paragraph IV (Patent) Challenges for VALGANCICLOVIR HYDROCHLORIDE

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 valganciclovir hydrochloride

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Dr Reddys	VALGANCICLOVIR HYDROCHLORIDE	valganciclovir hydrochloride	TABLET;ORAL	206876-001	Dec 12, 2017	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aurobindo Pharma Ltd	VALGANCICLOVIR HYDROCHLORIDE	valganciclovir hydrochloride	TABLET;ORAL	204750-001	Mar 31, 2016	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hoffmann La Roche	VALCYTE	valganciclovir hydrochloride	TABLET;ORAL	021304-001	Mar 29, 2001	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hoffmann La Roche	VALCYTE	valganciclovir hydrochloride	FOR SOLUTION;ORAL	022257-001	Aug 28, 2009	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Hetero Labs Ltd V	VALGANCICLOVIR HYDROCHLORIDE	valganciclovir hydrochloride	TABLET;ORAL	205166-001	Mar 18, 2016	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Msn	VALGANCICLOVIR HYDROCHLORIDE	valganciclovir hydrochloride	FOR SOLUTION;ORAL	210169-001	Feb 17, 2022	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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 valganciclovir hydrochloride

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

International Patents for valganciclovir hydrochloride

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Country	Patent Number	Title	Estimated Expiration
Cyprus	1113468		⤷ Sign Up
Portugal	2101733		⤷ Sign Up
Croatia	P20121033		⤷ Sign Up
Malaysia	152540	POWDER FORMULATION FOR VALGANCICLOVIR	⤷ Sign Up
Ukraine	93599	ПОРОШКОПОДІБНИЙ ПРЕПАРАТ ВАЛГАНЦИКЛОВІРУ[Порошкообразный препарат валганцикловира (powder valgancyclovir preparation)	⤷ Sign Up
Chile	2007003564	COMBINACION FARMACEUTICA QUE CONTIENE VALGANCICLOVIR CLORHIDRATO Y UN ACIDO ORGANICO NO HIGROSCOPICO; Y SU USO PARA TRATAR ENFERMEDADES MEDIADAS POR EL VIRUS HERPES SIMPLEX Y EL CITOMEGALOVIRUS.	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for valganciclovir hydrochloride

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0694547	SPC/GB02/027	United Kingdom	⤷ Sign Up	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	2002/028	Ireland	⤷ Sign Up	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
0694547	C300071	Netherlands	⤷ Sign Up	PRODUCT NAME: VALGANCICLOVIR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; REGISTRATION NO/DATE: RVG 25992 20010920
0694547	03C0003	France	⤷ Sign Up	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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