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Last Updated: August 14, 2020

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ZOVIRAX Drug Profile

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When do Zovirax patents expire, and when can generic versions of Zovirax launch?

Zovirax is a drug marketed by Mylan, Bausch, and Glaxosmithkline. and is included in six NDAs.

The generic ingredient in ZOVIRAX is acyclovir sodium. There are fifty-six drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the acyclovir sodium profile page.

US ANDA Litigation and Generic Entry Outlook for Zovirax

A generic version of ZOVIRAX was approved as acyclovir sodium by FRESENIUS KABI USA on May 13th, 1998.

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Drug patent expirations by year for ZOVIRAX
Drug Prices for ZOVIRAX

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Recent Clinical Trials for ZOVIRAX

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SponsorPhase
Squarex, LLCPhase 2
TKL Research, Inc.Phase 2
AiCuris Anti-infective Cures GmbHPhase 2

See all ZOVIRAX clinical trials

Paragraph IV (Patent) Challenges for ZOVIRAX
Tradename Dosage Ingredient NDA Submissiondate
ZOVIRAX INJECTABLE;INJECTION acyclovir sodium 018603

US Patents and Regulatory Information for ZOVIRAX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan ZOVIRAX acyclovir CAPSULE;ORAL 018828-001 Jan 25, 1985 DISCN Yes No   Start Trial   Start Trial   Start Trial
Mylan ZOVIRAX acyclovir SUSPENSION;ORAL 019909-001 Dec 22, 1989 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Glaxosmithkline ZOVIRAX acyclovir sodium INJECTABLE;INJECTION 018603-003 Aug 30, 1983 DISCN Yes No   Start Trial   Start Trial   Start Trial
Mylan ZOVIRAX acyclovir TABLET;ORAL 020089-001 Apr 30, 1991 DISCN Yes No   Start Trial   Start Trial   Start Trial
Bausch ZOVIRAX acyclovir CREAM;TOPICAL 021478-001 Dec 30, 2002 AB RX Yes No   Start Trial   Start Trial   Start Trial
Glaxosmithkline ZOVIRAX acyclovir sodium INJECTABLE;INJECTION 018603-002 Jun 29, 1989 DISCN Yes No   Start Trial   Start Trial   Start Trial
Bausch ZOVIRAX acyclovir OINTMENT;TOPICAL 018604-001 Mar 29, 1982 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
>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 ZOVIRAX

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mylan ZOVIRAX acyclovir TABLET;ORAL 020089-002 Apr 30, 1991   Start Trial   Start Trial
Mylan ZOVIRAX acyclovir CAPSULE;ORAL 018828-001 Jan 25, 1985   Start Trial   Start Trial
Glaxosmithkline ZOVIRAX acyclovir sodium INJECTABLE;INJECTION 018603-001 Oct 22, 1982   Start Trial   Start Trial
Bausch ZOVIRAX acyclovir CREAM;TOPICAL 021478-001 Dec 30, 2002   Start Trial   Start Trial
Bausch ZOVIRAX acyclovir OINTMENT;TOPICAL 018604-001 Mar 29, 1982   Start Trial   Start Trial
Mylan ZOVIRAX acyclovir TABLET;ORAL 020089-001 Apr 30, 1991   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for ZOVIRAX

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

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