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Last Updated: October 29, 2020

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

Recent Clinical Trials for valganciclovir hydrochloride

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

SponsorPhase
Centre Hospitalier CocodyPhase 2/Phase 3
University Hospital, BordeauxPhase 2/Phase 3
Institut National de la Santé Et de la Recherche Médicale, FrancePhase 2/Phase 3

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
Aurobindo Pharma Ltd VALGANCICLOVIR HYDROCHLORIDE valganciclovir hydrochloride TABLET;ORAL 204750-001 Mar 31, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Ajanta Pharma Ltd VALGANCICLOVIR HYDROCHLORIDE valganciclovir hydrochloride TABLET;ORAL 212234-001 Dec 26, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Cipla VALGANCICLOVIR HYDROCHLORIDE valganciclovir hydrochloride TABLET;ORAL 209672-001 Nov 9, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Hoffmann La Roche VALCYTE valganciclovir hydrochloride FOR SOLUTION;ORAL 022257-001 Aug 28, 2009 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Hoffmann La Roche VALCYTE valganciclovir hydrochloride TABLET;ORAL 021304-001 Mar 29, 2001 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Endo Pharms Inc VALGANCICLOVIR HYDROCHLORIDE valganciclovir hydrochloride TABLET;ORAL 200790-001 Nov 4, 2014 AB RX No No   Start Trial   Start Trial   Start 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   Start Trial   Start Trial
Hoffmann La Roche VALCYTE valganciclovir hydrochloride TABLET;ORAL 021304-001 Mar 29, 2001   Start Trial   Start 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   Start 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   Start 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   Start 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   Start 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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