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Last Updated: November 22, 2019

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VALGANCICLOVIR HYDROCHLORIDE Drug Profile

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When do Valganciclovir Hydrochloride patents expire, and when can generic versions of Valganciclovir Hydrochloride launch?

Valganciclovir Hydrochloride is a drug marketed by Actavis Labs Fl Inc, Aurobindo Pharma Ltd, Cipla, Dr Reddys, Dr Reddys Labs Ltd, Endo Pharms Inc, and Hetero Labs Ltd V. and is included in seven NDAs.

The generic ingredient in VALGANCICLOVIR HYDROCHLORIDE is valganciclovir hydrochloride. There are seventeen drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the valganciclovir hydrochloride profile page.

Drug patent expirations by year for VALGANCICLOVIR HYDROCHLORIDE
Recent Clinical Trials for VALGANCICLOVIR HYDROCHLORIDE

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SponsorPhase
Makerere UniversityPhase 2/Phase 3
Hospital Universitario 12 de OctubrePhase 2/Phase 3
Barcelona Institute for Global HealthPhase 2/Phase 3

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Recent Litigation for VALGANCICLOVIR HYDROCHLORIDE

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District Court Litigation
Case NameDate
Hoffmann-La Roche Inc. v. Airis Pharma Private Limited2017-10-13
Genentech, Inc. v. Sandoz Inc.2011-04-20
Roche Palo Alto LLC v. Endo Pharmaceuticals Inc.2010-03-31

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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
Actavis Labs Fl Inc VALGANCICLOVIR HYDROCHLORIDE valganciclovir hydrochloride FOR SOLUTION;ORAL 205220-001 Jul 18, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Hetero Labs Ltd V VALGANCICLOVIR HYDROCHLORIDE valganciclovir hydrochloride TABLET;ORAL 205166-001 Mar 18, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Dr Reddys VALGANCICLOVIR HYDROCHLORIDE valganciclovir hydrochloride TABLET;ORAL 206876-001 Dec 12, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd VALGANCICLOVIR HYDROCHLORIDE valganciclovir hydrochloride TABLET;ORAL 204750-001 Mar 31, 2016 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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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