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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-seven suppliers are listed for this compound. Additional details are available on the valacyclovir hydrochloride profile page.
US ANDA Litigation and Generic Entry Outlook for Valtrex
A generic version of VALTREX was approved as valacyclovir hydrochloride by SUN PHARM INDS LTD on January 31st, 2007.
Summary for VALTREX
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Suppliers / Packagers: | 2 |
Bulk Api Vendors: | 134 |
Clinical Trials: | 52 |
Patent Applications: | 4,577 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for VALTREX |
What excipients (inactive ingredients) are in VALTREX? | VALTREX excipients list |
DailyMed Link: | VALTREX at DailyMed |



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 | 020487-002 | 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 |
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 |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for VALTREX
Country | Patent Number | Estimated Expiration |
---|---|---|
Philippines | 19112 | Start Trial |
Italy | 8222848 | Start Trial |
Japan | H10512564 | Start Trial |
Australia | 612393 | Start Trial |
Poland | 185307 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for VALTREX
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
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 |
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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |