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Details for Generic Name: acyclovir

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Acyclovir is the generic ingredient in six branded drugs marketed by Actavis Elizabeth, Apotex Inc, Cadila Pharms Ltd, Dava Pharms Inc, Heritage Pharms Inc, Ivax Sub Teva Pharms, Lek Pharm, Mylan, Ranbaxy, Roxane, Stason, Teva, Teva Pharms, Watson Labs, Delcor Asset, Valeant Bermuda, Amneal Pharms, Mylan Pharms Inc, Actavis Mid Atlantic, Hi Tech Pharma, Innocutis Holdings, Carlsbad, Hetero Labs Ltd V, Sun Pharm Inds Ltd, Zydus Pharms Usa Inc, Abbvie, Hikma Maple , Apothecon, Aurobindo Pharma Ltd, Bedford, Fresenius Kabi Usa, Hospira, Teva Parenteral, and Glaxosmithkline, and is included in fifty-nine NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has thirty-two patent family members in twenty-four countries.

There are fifty-three drug master file entries for acyclovir. Nine suppliers are listed for this compound.

Summary for Generic Name: acyclovir

Tradenames:6
Patents:6
Applicants:34
NDAs:59
Drug Master File Entries: see list53
Suppliers / Packaging: see list21
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

Clinical Trials for: acyclovir

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Fresenius Kabi Usa
ACYCLOVIR SODIUM
acyclovir sodium
INJECTABLE;INJECTION075015-001Apr 30, 1998RXYes<disabled><disabled>
Amneal Pharms
ACYCLOVIR
acyclovir
OINTMENT;TOPICAL204605-001Jun 18, 2014RXNo<disabled><disabled>
Cadila Pharms Ltd
ACYCLOVIR
acyclovir
TABLET;ORAL202168-001Nov 15, 2013RXNo<disabled><disabled>
Actavis Elizabeth
ACYCLOVIR
acyclovir
TABLET;ORAL074870-001Jun 5, 1997DISCNNo<disabled><disabled>
Teva Pharms
ACYCLOVIR
acyclovir
TABLET;ORAL075021-001Mar 18, 1998DISCNNo<disabled><disabled>
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International Patent Family for Ingredient: acyclovir

Country Document Number Publication Date
Malaysia150072Nov 29, 2013
Portugal1998750Jan 08, 2010
Japan2013513575Apr 22, 2013
European Patent Office2216017Aug 11, 2010
European Patent Office2509586Oct 17, 2012
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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