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Last Updated: July 4, 2020

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VALTREX Drug Profile


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When do Valtrex patents expire, and what generic alternatives are available?

Valtrex is a drug marketed by Glaxosmithkline and is included in one NDA.

The generic ingredient in VALTREX is valacyclovir hydrochloride. There are twenty-three drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the valacyclovir hydrochloride profile page.

Paragraph IV (Patent) Challenges for VALTREX
Tradename Dosage Ingredient NDA Submissiondate
VALTREX TABLET;ORAL valacyclovir hydrochloride 020487

US Patents and Regulatory Information for VALTREX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline VALTREX valacyclovir hydrochloride TABLET;ORAL 020487-002 Jun 23, 1995 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Glaxosmithkline VALTREX valacyclovir hydrochloride TABLET;ORAL 020487-001 Jun 23, 1995 AB RX 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 VALTREX

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline VALTREX valacyclovir hydrochloride TABLET;ORAL 020487-001 Jun 23, 1995   Start Trial   Start Trial
Glaxosmithkline VALTREX valacyclovir hydrochloride TABLET;ORAL 020487-001 Jun 23, 1995   Start Trial   Start Trial
Glaxosmithkline VALTREX valacyclovir hydrochloride TABLET;ORAL 020487-002 Jun 23, 1995   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for VALTREX

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0077460 SPC/GB95/020 United Kingdom   Start Trial SPC/GB95/020:, EXPIRES: 20070907
0308065 97C0015 Belgium   Start Trial PRODUCT NAME: VALACICLOVIR HYDROCHLORID; NAT. REGISTRATION NO/DATE: 725 IS 144 F 3 19970219; FIRST REGISTRATION: IE PA 17/111/1 19941220
0077460 97C0035 Belgium   Start Trial PRODUCT NAME: VALACICLOVIR; NAT REG. NO/DATE: 725 IS 144 F 3; FIRST REG.: IE PA 17/111/1 19941212
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
McKesson
Express Scripts
Moodys
Colorcon
Dow

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