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Last Updated: July 4, 2020

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Valacyclovir hydrochloride - Generic Drug Details

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

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-five 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
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
Apotex VALACYCLOVIR HYDROCHLORIDE valacyclovir hydrochloride TABLET;ORAL 090500-001 Apr 4, 2014 AB RX No No   Start Trial   Start Trial   Start Trial
Jubilant Generics VALACYCLOVIR HYDROCHLORIDE valacyclovir hydrochloride TABLET;ORAL 201506-002 Apr 3, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Sun Pharm Inds Ltd VALACYCLOVIR HYDROCHLORIDE valacyclovir hydrochloride TABLET;ORAL 076588-002 Jan 31, 2007 AB RX No No   Start Trial   Start Trial   Start Trial
Glaxosmithkline VALTREX valacyclovir hydrochloride TABLET;ORAL 020487-001 Jun 23, 1995 AB RX Yes No   Start Trial   Start Trial   Start Trial
Hikma VALACYCLOVIR HYDROCHLORIDE valacyclovir hydrochloride TABLET;ORAL 078656-001 May 24, 2010 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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Serving leading biopharmaceutical companies globally:

McKesson
AstraZeneca
Mallinckrodt
Boehringer Ingelheim
Harvard Business School
Baxter

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