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Valacyclovir hydrochloride - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for valacyclovir hydrochloride?

Valacyclovir hydrochloride is the generic ingredient in two branded drugs marketed by Apotex Inc, Jubilant Generics, Dr Reddys Labs Ltd, Wockhardt, Mylan Pharms Inc, Cipla Ltd, Hetero Labs Ltd V, Teva Pharms, West-ward Pharms Int, Mylan, Watson Labs Inc, Sandoz, Aurobindo Pharma, Glaxosmithkline, and Sun Pharm Inds Ltd, and is included in fifteen NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Valacyclovir hydrochloride has one hundred and two patent family members in forty-five countries.

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

Summary for Generic Name: valacyclovir hydrochloride

Tradenames:2
Patents:3
Applicants:15
NDAs:15
Drug Master File Entries: see list22
Suppliers / Packagers: see list48
Bulk Api Vendors: see list80
Clinical Trials: see list1,025
Patent Applications: see list5,761
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:valacyclovir hydrochloride at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline
VALTREX
valacyclovir hydrochloride
TABLET;ORAL020487-001Jun 23, 1995RXYesNo6,107,302*PED► Subscribe ► Subscribe
Aurobindo Pharma
VALACYCLOVIR HYDROCHLORIDE
valacyclovir hydrochloride
TABLET;ORAL090682-001May 24, 2010RXNoNo► Subscribe► Subscribe
Glaxosmithkline
VALTREX
valacyclovir hydrochloride
TABLET;ORAL020487-002Jun 23, 1995RXYesYes6,107,302*PED► Subscribe ► Subscribe
Mylan
VALACYCLOVIR HYDROCHLORIDE
valacyclovir hydrochloride
TABLET;ORAL078070-001May 24, 2010RXNoNo► Subscribe► Subscribe
Sandoz
VALACYCLOVIR HYDROCHLORIDE
valacyclovir hydrochloride
TABLET;ORAL077478-002May 24, 2010RXNoNo► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: valacyclovir hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline
VALTREX
valacyclovir hydrochloride
TABLET;ORAL020487-001Jun 23, 19956,107,302*PED► Subscribe
Glaxosmithkline
VALTREX
valacyclovir hydrochloride
TABLET;ORAL020487-002Jun 23, 19954,567,182► Subscribe
Glaxosmithkline
VALTREX
valacyclovir hydrochloride
TABLET;ORAL020487-001Jun 23, 19954,957,924*PED► Subscribe
Glaxosmithkline
VALTREX
valacyclovir hydrochloride
TABLET;ORAL020487-001Jun 23, 19954,567,182► Subscribe
Glaxosmithkline
VALTREX
valacyclovir hydrochloride
TABLET;ORAL020487-001Jun 23, 19955,879,706*PED► Subscribe
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International Patent Family for Ingredient: valacyclovir hydrochloride

Country Document Number Estimated Expiration
Austria190483► Subscribe
Hong Kong1003055► Subscribe
Bulgaria101831► Subscribe
Israel116831► Subscribe
Finland973063► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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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 verifification 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.

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