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Generated: April 23, 2019

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Acyclovir - Generic Drug Details

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What are the generic drug sources for acyclovir and what is the scope of acyclovir freedom to operate?

Acyclovir is the generic ingredient in six branded drugs marketed by Actavis Elizabeth, Apotex Inc, Boscogen, Cadila Pharms Ltd, Carlsbad Technology, Chartwell Molecules, Dava Pharms Inc, Heritage Pharms Inc, Ivax Sub Teva Pharms, Lek Pharm, Mylan, Ranbaxy, Roxane, Teva, Teva Pharms, Watson Labs, Zydus Pharms Usa Inc, Mylan Pharms Inc, Perrigo Uk Finco, Bausch, Alembic Pharms Ltd, Amneal Pharms, Cipla, Fougera Pharms Inc, G And W Labs Inc, Glenmark Pharms Ltd, Taro, Tolmar, Torrent, Actavis Mid Atlantic, Hi Tech Pharma, Epi Hlth, Carlsbad, Hetero Labs Ltd V, Sun Pharm Inds Ltd, Yiling Pharm Ltd, Abbvie, Eurohlth Intl Sarl, Apothecon, Athenex Inc, Aurobindo Pharma Ltd, Fresenius Kabi Usa, Hikma Pharms, Hospira, Mylan Labs Ltd, Teva Parenteral, and Glaxosmithkline, and is included in seventy-six NDAs. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Acyclovir has forty-three patent family members in twenty-eight countries.

There are fifty-six drug master file entries for acyclovir. Seventy-eight suppliers are listed for this compound. There are three tentative approvals for this compound.

Tentative approvals for ACYCLOVIR
Applicant Application No. Strength Dosage Form
➤ Try a Free Trial➤ Try a Free Trial200MGCAPSULE;ORAL
➤ Try a Free Trial➤ Try a Free Trial800MGTABLET;ORAL
➤ Try a Free Trial➤ Try a Free Trial400MGTABLET;ORAL

US Patents and Regulatory Information for acyclovir

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Zydus Pharms Usa Inc ACYCLOVIR acyclovir TABLET;ORAL 204314-001 Aug 19, 2014 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Mylan Labs Ltd ACYCLOVIR SODIUM acyclovir sodium INJECTABLE;INJECTION 203927-002 Mar 29, 2017 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Apotex Inc ACYCLOVIR acyclovir TABLET;ORAL 077309-001 Sep 29, 2005 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
G And W Labs Inc ACYCLOVIR acyclovir OINTMENT;TOPICAL 205591-001 Nov 13, 2017 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Hospira ACYCLOVIR SODIUM acyclovir sodium INJECTABLE;INJECTION 074663-001 Apr 22, 1997 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for acyclovir

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bausch ZOVIRAX acyclovir OINTMENT;TOPICAL 018604-001 Mar 29, 1982 ➤ Try a Free Trial ➤ Try a Free Trial
Mylan Pharms Inc ZOVIRAX acyclovir TABLET;ORAL 020089-001 Apr 30, 1991 ➤ Try a Free Trial ➤ Try a Free Trial
Mylan Pharms Inc ZOVIRAX acyclovir CAPSULE;ORAL 018828-001 Jan 25, 1985 ➤ Try a Free Trial ➤ Try a Free Trial
Mylan Pharms Inc ZOVIRAX acyclovir TABLET;ORAL 020089-002 Apr 30, 1991 ➤ Try a Free Trial ➤ Try a Free Trial
Bausch ZOVIRAX acyclovir CREAM;TOPICAL 021478-001 Dec 30, 2002 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for acyclovir

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0809498 10C0038 France ➤ Try a Free Trial PRODUCT NAME: ACYCLOVIR ET HYDROCORTISONE; NAT. REGISTRATION NO/DATE: NL 36 826 20100420; FIRST REGISTRATION: SK - 2108/08467-R 20091026
0809498 SPC/GB10/012 United Kingdom ➤ Try a Free Trial PRODUCT NAME: A COMBINATION OF ACYCLOVIR AND HYDROCORTISONE; REGISTERED: UK PL18191/0001-0001 20091112
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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