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VALTREX Drug Profile
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» See Plans and PricingWhen 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.
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: | 1 |
| Bulk Api Vendors: | 127 |
| Clinical Trials: | 51 |
| Patent Applications: | 4,870 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for VALTREX |
| Drug Sales Revenues: | Drug sales revenues for VALTREX |
| 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 | 020487-001 | 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 |
International Patents for VALTREX
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| African Regional IP Organization (ARIPO) | 160 | Start Trial |
| Cyprus | 2182 | Start Trial |
| Australia | 564576 | Start Trial |
| >Country | >Patent Number | >Estimated 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 |
