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, Chartwell Rx, Cipla, Graviti Pharms, Hetero Labs Ltd V, Hikma, Jubilant Generics, Mylan Pharms Inc, Norvium Bioscience, 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

US Patents:	0
Tradenames:	2
Applicants:	17
NDAs:	17
Drug Master File Entries:	22
Finished Product Suppliers / Packagers:	42
Raw Ingredient (Bulk) Api Vendors:	90
Clinical Trials:	120
Patent Applications:	2,142
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

Sponsor	Phase
The Leukemia and Lymphoma Society	Phase 2
Loxo Oncology, Inc.	Phase 2
University of California, San Francisco	Early Phase 1

See all valacyclovir hydrochloride clinical trials

Pharmacology for valacyclovir hydrochloride

Drug Class	Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor
Mechanism of Action	DNA Polymerase Inhibitors

US Patents and Regulatory Information for valacyclovir hydrochloride

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxosmithkline	VALTREX	valacyclovir hydrochloride	TABLET;ORAL	020487-002	Jun 23, 1995	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma	VALACYCLOVIR HYDROCHLORIDE	valacyclovir hydrochloride	TABLET;ORAL	078656-002	May 24, 2010		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sun Pharm Inds Ltd	VALACYCLOVIR HYDROCHLORIDE	valacyclovir hydrochloride	TABLET;ORAL	076588-002	Jan 31, 2007	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hetero Labs Ltd V	VALACYCLOVIR HYDROCHLORIDE	valacyclovir hydrochloride	TABLET;ORAL	203047-001	Apr 8, 2015	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	VALTREX	valacyclovir hydrochloride	TABLET;ORAL	020487-002	Jun 23, 1995	⤷ Sign Up	⤷ Sign Up
Glaxosmithkline	VALTREX	valacyclovir hydrochloride	TABLET;ORAL	020487-002	Jun 23, 1995	⤷ Sign Up	⤷ Sign Up
Glaxosmithkline	VALTREX	valacyclovir hydrochloride	TABLET;ORAL	020487-001	Jun 23, 1995	⤷ Sign Up	⤷ Sign Up
Glaxosmithkline	VALTREX	valacyclovir hydrochloride	TABLET;ORAL	020487-001	Jun 23, 1995	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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