Baraclude is a drug owned by Bristol Myers Squibb. It is protected by 2 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 Sep 20, 2017. Details of Baraclude'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). | |||
|
US5206244 (Pediatric) | Hydroxymethyl (methylenecyclopentyl) purines and pyrimidines |
Aug, 2015
(9 years ago) |
Expired
|
| US5206244 | Hydroxymethyl (methylenecyclopentyl) purines and pyrimidines |
Feb, 2015
(9 years ago) |
Expired
|
FDA has granted several exclusivities to Baraclude. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Baraclude, 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 Baraclude.
Exclusivity Information
Baraclude holds 3 exclusivities. All of its exclusivities have expired in 2017. Details of Baraclude's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Dosing Schedule(D-127) | Oct 15, 2013 |
| New Patient Population(NPP) | Oct 12, 2015 |
| Pediatric Exclusivity(PED) | Sep 20, 2017 |
US patents provide insights into the exclusivity only within the United States, but Baraclude 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 Baraclude's family patents as well as insights into ongoing legal events on those patents.
Baraclude's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Baraclude's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 20, 2017 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Baraclude Generic API suppliers:
Entecavir is the generic name for the brand Baraclude. 16 different companies have already filed for the generic of Baraclude, with Chartwell Rx having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Baraclude's generic
How can I launch a generic of Baraclude before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Baraclude's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Baraclude'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 Baraclude -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.5 mg and 1 mg | 14 Jun, 2010 | 1 | 26 Aug, 2014 | 21 Aug, 2015 | Eligible |
About Baraclude
Baraclude is a drug owned by Bristol Myers Squibb. Baraclude uses Entecavir as an active ingredient. Baraclude was launched by Bristol Myers Squibb in 2005.
Approval Date:
Baraclude was approved by FDA for market use on 29 March, 2005.
Active Ingredient:
Baraclude uses Entecavir as the active ingredient. Check out other Drugs and Companies using Entecavir ingredient
Dosage:
Baraclude is available in the following dosage forms - tablet form for oral use, solution form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 1MG | TABLET | Prescription | ORAL |
| 0.5MG | TABLET | Prescription | ORAL |
| 0.05MG/ML | SOLUTION | Prescription | ORAL |