Plavix is a drug owned by Sanofi Aventis Us Llc. 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 Dec 10, 2019. Details of Plavix'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). | |||
|
US6504030 (Pediatric) | Polymorphic form of clopidogrel hydrogen sulphate |
Dec, 2019
(5 years ago) |
Expired
|
|
US6429210 (Pediatric) | Polymorphic clopidogrel hydrogenesulphate form |
Dec, 2019
(5 years ago) |
Expired
|
| US6504030 | Polymorphic form of clopidogrel hydrogen sulphate |
Jun, 2019
(5 years ago) |
Expired
|
| US6429210 | Polymorphic clopidogrel hydrogenesulphate form |
Jun, 2019
(5 years ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Plavix's patents.
Latest Legal Activities on Plavix's Patents
Given below is the list of recent legal activities going on the following patents of Plavix.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| File Marked Found | 26 May, 2010 | US6504030 |
| Correspondence Address Change Critical | 02 Aug, 2006 | US6504030 |
| Recordation of Patent Grant Mailed Critical | 10 Jan, 2003 | US6504030 |
| Patent Issue Date Used in PTA Calculation Critical | 07 Jan, 2003 | US6504030 |
| Issue Notification Mailed Critical | 19 Dec, 2002 | US6504030 |
| Receipt into Pubs | 06 Dec, 2002 | US6504030 |
| Application Is Considered Ready for Issue Critical | 03 Dec, 2002 | US6504030 |
| Issue Fee Payment Received Critical | 21 Nov, 2002 | US6504030 |
| Issue Fee Payment Verified Critical | 21 Nov, 2002 | US6504030 |
| Workflow - Drawings Sent to Contractor | 20 Nov, 2002 | US6504030 |
FDA has granted several exclusivities to Plavix. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Plavix, 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 Plavix.
Exclusivity Information
Plavix holds 2 exclusivities. All of its exclusivities have expired in 2014. Details of Plavix's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| M(M-61) | May 06, 2014 |
| Pediatric Exclusivity(PED) | Nov 06, 2014 |
US patents provide insights into the exclusivity only within the United States, but Plavix 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 Plavix's family patents as well as insights into ongoing legal events on those patents.
Plavix's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Plavix's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 10, 2019 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Plavix Generic API suppliers:
Clopidogrel Bisulfate is the generic name for the brand Plavix. 23 different companies have already filed for the generic of Plavix, with Rising having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Plavix's generic
How can I launch a generic of Plavix before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Plavix's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Plavix'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 Plavix -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 75 mg | |||||
| 300 mg | 04 Mar, 2009 | 1 | 17 May, 2012 | 10 Jun, 2019 | Eligible |
About Plavix
Plavix is a drug owned by Sanofi Aventis Us Llc. Plavix uses Clopidogrel Bisulfate as an active ingredient. Plavix was launched by Sanofi Aventis Us in 1997.
Approval Date:
Plavix was approved by FDA for market use on 17 November, 1997.
Active Ingredient:
Plavix uses Clopidogrel Bisulfate as the active ingredient. Check out other Drugs and Companies using Clopidogrel Bisulfate ingredient
Dosage:
Plavix is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 300MG BASE | TABLET | Prescription | ORAL |
| EQ 75MG BASE | TABLET | Prescription | ORAL |