Ranexa is a drug owned by Menarini International Operations Luxembourg Sa. It is protected by 10 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 May 27, 2019. Details of Ranexa'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). | |||
| US6369062 | Sustained release ranolazine formulations |
May, 2019
(5 years ago) |
Expired
|
| US6503911 | Sustained release ranolazine formulations |
May, 2019
(5 years ago) |
Expired
|
| US6617328 | Sustained release ranolazine formulations |
May, 2019
(5 years ago) |
Expired
|
| US6525057 | Sustained release ranolazine formulations |
May, 2019
(5 years ago) |
Expired
|
| US6479496 | Methods for treating angina with ranolazine |
May, 2019
(5 years ago) |
Expired
|
| US6620814 | Sustained release ranolazine formulations |
May, 2019
(5 years ago) |
Expired
|
| US6864258 | Sustained release ranolazine formulations |
May, 2019
(5 years ago) |
Expired
|
| US6562826 | Sustained release ranolazine formulations |
May, 2019
(5 years ago) |
Expired
|
| US6852724 | Sustained release ranolazine formulations |
May, 2019
(5 years ago) |
Expired
|
| US6303607 | Method for administering a sustained release ranolanolazine formulation |
May, 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 Ranexa's patents.
Latest Legal Activities on Ranexa's Patents
Given below is the list of recent legal activities going on the following patents of Ranexa.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| File Marked Found | 20 Dec, 2016 | US6620814 (Litigated) |
| File Marked Found | 15 Dec, 2016 | US6525057 (Litigated) |
| File Marked Found | 12 Dec, 2016 | US6525057 (Litigated) |
| Post Issue Communication - Certificate of Correction | 11 Aug, 2015 | US6562826 (Litigated) |
| Case Docketed to Examiner in GAU Critical | 05 Aug, 2015 | US6562826 (Litigated) |
| Post Issue Communication - Certificate of Correction | 19 Mar, 2015 | US6620814 (Litigated) |
| Post Issue Communication - Certificate of Correction | 21 Jan, 2015 | US6852724 (Litigated) |
| Correspondence Address Change Critical | 01 Mar, 2012 | US6525057 (Litigated) |
| Correspondence Address Change Critical | 01 Mar, 2012 | US6562826 (Litigated) |
| Correspondence Address Change Critical | 01 Mar, 2012 | US6503911 (Litigated) |
US patents provide insights into the exclusivity only within the United States, but Ranexa 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 Ranexa's family patents as well as insights into ongoing legal events on those patents.
Ranexa's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Ranexa's generic launch date based on the expiry of its last outstanding patent is estimated to be May 27, 2019 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Ranexa Generic API suppliers:
Ranolazine is the generic name for the brand Ranexa. 24 different companies have already filed for the generic of Ranexa, with Accord Hlthcare having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Ranexa's generic
How can I launch a generic of Ranexa before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Ranexa's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Ranexa'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 Ranexa -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 500 mg and 1000 mg | 17 May, 2010 | 1 | 29 Jul, 2013 | 27 May, 2019 | Eligible |
Alternative Brands for Ranexa
Ranexa which is used for managing chronic angina through extended release administration of ranolazine., has several other brand drugs using the same active ingredient (Ranolazine). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | |
|---|---|---|
| Spil |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Ranolazine, Ranexa's active ingredient. Check the complete list of approved generic manufacturers for Ranexa
About Ranexa
Ranexa is a drug owned by Menarini International Operations Luxembourg Sa. It is used for managing chronic angina through extended release administration of ranolazine. Ranexa uses Ranolazine as an active ingredient. Ranexa was launched by Menarini Intl in 2007.
Approval Date:
Ranexa was approved by FDA for market use on 12 February, 2007.
Active Ingredient:
Ranexa uses Ranolazine as the active ingredient. Check out other Drugs and Companies using Ranolazine ingredient
Treatment:
Ranexa is used for managing chronic angina through extended release administration of ranolazine.
Dosage:
Ranexa is available in tablet, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE | Discontinued | ORAL |
| 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE | Discontinued | ORAL |