Valacyclovir hydrochloride - Generic Drug Details

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-one 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:	41
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
Loxo Oncology, Inc.	Phase 2
The Leukemia and Lymphoma Society	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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Graviti Pharms	VALACYCLOVIR HYDROCHLORIDE	valacyclovir hydrochloride	TABLET;ORAL	079012-002	May 24, 2010	AB	RX	No	No
Zydus Lifesciences	VALACYCLOVIR HYDROCHLORIDE	valacyclovir hydrochloride	TABLET;ORAL	079137-001	Dec 29, 2017	AB	RX	No	No
Mylan Pharms Inc	VALACYCLOVIR HYDROCHLORIDE	valacyclovir hydrochloride	TABLET;ORAL	078518-002	May 24, 2010	AB	RX	No	No
Glaxosmithkline	VALTREX	valacyclovir hydrochloride	TABLET;ORAL	020487-001	Jun 23, 1995	AB	RX	Yes	No
Hikma	VALACYCLOVIR HYDROCHLORIDE	valacyclovir hydrochloride	TABLET;ORAL	078656-001	May 24, 2010		DISCN	No	No
Hetero Labs Ltd V	VALACYCLOVIR HYDROCHLORIDE	valacyclovir hydrochloride	TABLET;ORAL	203047-001	Apr 8, 2015	AB	RX	No	No
Jubilant Generics	VALACYCLOVIR HYDROCHLORIDE	valacyclovir hydrochloride	TABLET;ORAL	201506-001	Apr 3, 2012	AB	RX	No	No

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
Glaxosmithkline	VALTREX	valacyclovir hydrochloride	TABLET;ORAL	020487-001	Jun 23, 1995
Glaxosmithkline	VALTREX	valacyclovir hydrochloride	TABLET;ORAL	020487-001	Jun 23, 1995
Glaxosmithkline	VALTREX	valacyclovir hydrochloride	TABLET;ORAL	020487-001	Jun 23, 1995
Glaxosmithkline	VALTREX	valacyclovir hydrochloride	TABLET;ORAL	020487-002	Jun 23, 1995
Glaxosmithkline	VALTREX	valacyclovir hydrochloride	TABLET;ORAL	020487-002	Jun 23, 1995
Glaxosmithkline	VALTREX	valacyclovir hydrochloride	TABLET;ORAL	020487-001	Jun 23, 1995