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
(11 years ago) |
Expired
|
| US5206244 | Hydroxymethyl (methylenecyclopentyl) purines and pyrimidines |
Feb, 2015
(11 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
Clinical Trials
Recent Clinical Trials on Baraclude:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
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. 17 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 | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| 14 Jun, 2010 | 21 Aug, 2015 | Eligible | 26 Aug, 2014 | Less |
About Baraclude
Baraclude is a drug owned by Bristol Myers Squibb. Baraclude uses Entecavir as an active ingredient. Baraclude was launched by Bristol Myers 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 |