You are 3 steps away
from making better decisions

Serving leading biopharmaceutical companies globally:

Express Scripts
Baxter
Dow
Moodys
Merck
Harvard Business School

Last Updated: March 9, 2021

DrugPatentWatch Database Preview

Valacyclovir hydrochloride - Generic Drug Details

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

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, Atlantide, 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, Yiling, 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-seven suppliers are listed for this compound.

Summary for valacyclovir hydrochloride
US Patents:0
Tradenames:2
Applicants:17
NDAs:17
Drug Master File Entries: 23
Suppliers / Packagers: 37
Bulk Api Vendors: 70
Clinical Trials: 110
Patent Applications: 1,736
Formulation / Manufacturing:see details
What excipients (inactive ingredients) are in valacyclovir hydrochloride?valacyclovir hydrochloride excipients list
DailyMed Link:valacyclovir hydrochloride at DailyMed
Recent Clinical Trials for valacyclovir hydrochloride

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

SponsorPhase
Alzheimer's AssociationPhase 2
University of Maryland, BaltimorePhase 4
University of Alabama at BirminghamPhase 1

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
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
Jubilant Generics VALACYCLOVIR HYDROCHLORIDE valacyclovir hydrochloride TABLET;ORAL 201506-002 Apr 3, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Yiling VALACYCLOVIR HYDROCHLORIDE valacyclovir hydrochloride TABLET;ORAL 209553-001 Mar 18, 2020 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
Sandoz VALACYCLOVIR HYDROCHLORIDE valacyclovir hydrochloride TABLET;ORAL 077478-001 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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline VALTREX valacyclovir hydrochloride TABLET;ORAL 020487-002 Jun 23, 1995   Start Trial   Start Trial
Glaxosmithkline VALTREX valacyclovir hydrochloride TABLET;ORAL 020487-001 Jun 23, 1995   Start Trial   Start Trial
Glaxosmithkline VALTREX valacyclovir hydrochloride TABLET;ORAL 020487-002 Jun 23, 1995   Start Trial   Start Trial
Glaxosmithkline VALTREX valacyclovir hydrochloride TABLET;ORAL 020487-001 Jun 23, 1995   Start Trial   Start Trial
Glaxosmithkline VALTREX valacyclovir hydrochloride TABLET;ORAL 020487-001 Jun 23, 1995   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

McKesson
AstraZeneca
Mallinckrodt
Boehringer Ingelheim
Harvard Business School
Baxter

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.