Valtrex is a drug owned by Glaxosmithkline. It is protected by 4 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 19, 2016. Details of Valtrex's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US5879706 (Pediatric) | Valaciclovir tablets containing colloidal silicon dioxide |
Jul, 2016
(8 years ago) |
Expired
|
|
US6107302 (Pediatric) | Guanine derivative |
Jul, 2016
(8 years ago) |
Expired
|
| US6107302 | Guanine derivative |
Jan, 2016
(8 years ago) |
Expired
|
| US5879706 | Valaciclovir tablets containing colloidal silicon dioxide |
Jan, 2016
(8 years ago) |
Expired
|
FDA has granted several exclusivities to Valtrex. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Valtrex, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Valtrex.
Exclusivity Information
Valtrex holds 3 exclusivities. All of its exclusivities have expired in 2012. Details of Valtrex's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-570) | Sep 02, 2011 |
| New Patient Population(NPP) | Sep 02, 2011 |
| Pediatric Exclusivity(PED) | Mar 02, 2012 |
US patents provide insights into the exclusivity only within the United States, but Valtrex is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Valtrex's family patents as well as insights into ongoing legal events on those patents.
Valtrex's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Valtrex's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 19, 2016 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Valtrex Generic API suppliers:
Valacyclovir Hydrochloride is the generic name for the brand Valtrex. 16 different companies have already filed for the generic of Valtrex, with Apotex having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Valtrex's generic
How can I launch a generic of Valtrex before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Valtrex's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Valtrex's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Valtrex -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 500 mg and 1000 mg |
About Valtrex
Valtrex is a drug owned by Glaxosmithkline. It is used for treating herpes infections and reducing transmission risk. Valtrex uses Valacyclovir Hydrochloride as an active ingredient. Valtrex was launched by Glaxosmithkline in 1995.
Approval Date:
Valtrex was approved by FDA for market use on 23 June, 1995.
Active Ingredient:
Valtrex uses Valacyclovir Hydrochloride as the active ingredient. Check out other Drugs and Companies using Valacyclovir Hydrochloride ingredient
Treatment:
Valtrex is used for treating herpes infections and reducing transmission risk.
Dosage:
Valtrex is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 1GM BASE | TABLET | Prescription | ORAL |
| EQ 500MG BASE | TABLET | Prescription | ORAL |