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Last Updated: December 4, 2021

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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, Granules, Aurobindo Pharma Ltd, Cipla, Dr Reddys, Dr Reddys Labs Ltd, Endo Pharms Inc, Hetero Labs Ltd V, and Mylan, and is included in thirteen 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. Nineteen suppliers are listed for this compound.

Recent Clinical Trials for valganciclovir hydrochloride

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

SponsorPhase
Merck Sharp & Dohme Corp.Phase 2
Laureate Institute for Brain Research, Inc.Phase 1/Phase 2
Fernanda P Silveira, MD, MSPhase 2

See all valganciclovir hydrochloride clinical trials

Pharmacology for valganciclovir hydrochloride
Paragraph IV (Patent) Challenges for VALGANCICLOVIR HYDROCHLORIDE
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 valganciclovir hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Dr Reddys Labs Ltd VALGANCICLOVIR HYDROCHLORIDE valganciclovir hydrochloride TABLET;ORAL 203511-001 Nov 4, 2014 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Mylan VALGANCICLOVIR HYDROCHLORIDE valganciclovir hydrochloride TABLET;ORAL 205151-001 Mar 3, 2021 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Aurobindo Pharma Ltd VALGANCICLOVIR HYDROCHLORIDE valganciclovir hydrochloride TABLET;ORAL 204750-001 Mar 31, 2016 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Hoffmann La Roche VALCYTE valganciclovir hydrochloride TABLET;ORAL 021304-001 Mar 29, 2001 AB RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever 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 valganciclovir hydrochloride

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

Supplementary Protection Certificates for valganciclovir hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0694547 C300071 Netherlands ⤷  Free Forever 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 03C0003 France ⤷  Free Forever 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 SPC/GB02/027 United Kingdom ⤷  Free Forever 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
0694547 2002/028 Ireland ⤷  Free Forever Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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