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Last Updated: March 29, 2024

Valacyclovir hydrochloride - Generic Drug Details


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

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

There are twenty-two drug master file entries for valacyclovir hydrochloride. Forty-two suppliers are listed for this compound.

Summary for valacyclovir hydrochloride
Recent Clinical Trials for valacyclovir hydrochloride

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

SponsorPhase
Loxo Oncology, Inc.Phase 2
The Leukemia and Lymphoma SocietyPhase 2
University of California, San FranciscoEarly Phase 1

See all valacyclovir hydrochloride clinical trials

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
Hikma VALACYCLOVIR HYDROCHLORIDE valacyclovir hydrochloride TABLET;ORAL 078656-001 May 24, 2010 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline VALTREX valacyclovir hydrochloride TABLET;ORAL 020487-002 Jun 23, 1995 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan Pharms Inc VALACYCLOVIR HYDROCHLORIDE valacyclovir hydrochloride TABLET;ORAL 078518-002 May 24, 2010 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Watson Labs Inc VALACYCLOVIR HYDROCHLORIDE valacyclovir hydrochloride TABLET;ORAL 090370-002 Mar 16, 2011 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hetero Labs Ltd V VALACYCLOVIR HYDROCHLORIDE valacyclovir hydrochloride TABLET;ORAL 203047-002 Apr 8, 2015 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Cipla VALACYCLOVIR HYDROCHLORIDE valacyclovir hydrochloride TABLET;ORAL 077135-002 May 24, 2010 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sun Pharm Inds Ltd VALACYCLOVIR HYDROCHLORIDE valacyclovir hydrochloride TABLET;ORAL 076588-001 Jan 31, 2007 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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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