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Last Updated: August 10, 2020

DrugPatentWatch Database Preview

VALACYCLOVIR HYDROCHLORIDE - Generic Drug Details

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What are the generic sources for valacyclovir hydrochloride and what is the scope of patent protection?

Valacyclovir hydrochloride is the generic ingredient in two branded drugs marketed by Apotex, Aurobindo Pharma, Cipla, Hetero Labs Ltd V, Hikma, Jubilant Generics, Mylan, Mylan Pharms Inc, Sandoz, Sun Pharm Inds Ltd, Teva Pharms, Time-cap Labs Inc, Watson Labs Inc, Wockhardt, Yiling Pharm Ltd, Zydus Pharms, and Glaxosmithkline, and is included in seventeen NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-three drug master file entries for valacyclovir hydrochloride. Thirty-four suppliers are listed for this compound.

Recent Clinical Trials for VALACYCLOVIR HYDROCHLORIDE

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SponsorPhase
University of Alabama at BirminghamPhase 1
Radboud UniversityN/A
The Methodist Hospital SystemPhase 2

See all VALACYCLOVIR HYDROCHLORIDE clinical trials

Paragraph IV (Patent) Challenges for VALACYCLOVIR HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
VALTREX TABLET;ORAL valacyclovir hydrochloride 020487

US Patents and Regulatory Information for VALACYCLOVIR HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Cipla VALACYCLOVIR HYDROCHLORIDE valacyclovir hydrochloride TABLET;ORAL 077135-002 May 24, 2010 AB RX No No   Start Trial   Start Trial   Start Trial
Wockhardt VALACYCLOVIR HYDROCHLORIDE valacyclovir hydrochloride TABLET;ORAL 090216-001 May 24, 2010 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan VALACYCLOVIR HYDROCHLORIDE valacyclovir hydrochloride TABLET;ORAL 078070-002 May 24, 2010 DISCN No No   Start Trial   Start Trial   Start Trial
Hetero Labs Ltd V VALACYCLOVIR HYDROCHLORIDE valacyclovir hydrochloride TABLET;ORAL 203047-002 Apr 8, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
Time-cap Labs Inc VALACYCLOVIR HYDROCHLORIDE valacyclovir hydrochloride TABLET;ORAL 079012-002 May 24, 2010 AB RX No No   Start Trial   Start Trial   Start Trial
Sandoz VALACYCLOVIR HYDROCHLORIDE valacyclovir hydrochloride TABLET;ORAL 077478-002 May 24, 2010 AB RX No No   Start Trial   Start Trial   Start Trial
Yiling Pharm Ltd VALACYCLOVIR HYDROCHLORIDE valacyclovir hydrochloride TABLET;ORAL 209553-002 Mar 18, 2020 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 VALACYCLOVIR HYDROCHLORIDE

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