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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-four drug master file entries for acyclovir. Nine suppliers are listed for this compound.

Summary for Generic Name: acyclovir

Drug Master File Entries: see list54
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
Teva Parenteral
acyclovir sodium
INJECTABLE;INJECTION074969-002Aug 26, 1997DISCNNo<disabled><disabled>
Innocutis Holdings
TABLET;BUCCAL203791-001Apr 12, 2013RXYes8,592,434<disabled>Y<disabled>
CAPSULE;ORAL075090-001Jan 26, 1999RXNo<disabled><disabled>
Teva Parenteral
acyclovir sodium
INJECTABLE;INJECTION074969-001Aug 26, 1997DISCNNo<disabled><disabled>
acyclovir sodium
INJECTABLE;INJECTION074897-002Feb 27, 1998DISCNNo<disabled><disabled>
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International Patent Family for Ingredient: acyclovir

Country Document Number Publication Date
Hong Kong1121692Jan 15, 2010
Slovenia1998750Feb 26, 2010
Canada2647123Oct 04, 2007
South Korea101335185Dec 02, 2013
Portugal1998750Jan 08, 2010
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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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