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Last Updated: February 19, 2020

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ZOVIRAX Drug Profile


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Which patents cover Zovirax, 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
AiCuris Anti-infective Cures GmbHPhase 2
TKL Research, Inc.Phase 2

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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
>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 CAPSULE;ORAL 018828-001 Jan 25, 1985   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

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Serving leading biopharmaceutical companies globally:

Colorcon
Johnson and Johnson
AstraZeneca
Harvard Business School
Boehringer Ingelheim
Moodys

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