Sular is a drug owned by Covis Pharma Gmbh. It is protected by 1 US drug patent filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Nov 30, 2014. Details of Sular'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). | |||
| US5626874 | Controlled release pharmaceutical tablet having lenticular form |
Nov, 2014
(10 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Sular 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 Sular's family patents as well as insights into ongoing legal events on those patents.
Sular's Family Patents
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Generic Launch
Generic Release Date:
Sular's generic launch date based on the expiry of its last outstanding patent is estimated to be Nov 30, 2014 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Sular Generic API suppliers:
Nisoldipine is the generic name for the brand Sular. 2 different companies have already filed for the generic of Sular, with Mylan having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Sular's generic
How can I launch a generic of Sular before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Sular's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Sular'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 Sular -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 8.5 mg and 17 mg | 02 Mar, 2009 | 1 | 26 Jan, 2011 | 06 Jun, 2012 | Eligible |
| 20 mg and 30 mg | 07 Nov, 2007 | 1 | 25 Jul, 2008 | 08 Jun, 2008 | Extinguished |
| 25.5 mg and 34 mg | 28 Nov, 2008 | 1 | 26 Jan, 2011 | 30 Nov, 2014 | Eligible |
| 40 mg | 11 Jun, 2007 | 1 | 25 Jul, 2008 | 08 Jun, 2008 | Extinguished |
About Sular
Sular is a drug owned by Covis Pharma Gmbh. Sular uses Nisoldipine as an active ingredient. Sular was launched by Covis in 2008.
Approval Date:
Sular was approved by FDA for market use on 02 January, 2008.
Active Ingredient:
Sular uses Nisoldipine as the active ingredient. Check out other Drugs and Companies using Nisoldipine ingredient
Dosage:
Sular is available in tablet, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 34MG | TABLET, EXTENDED RELEASE | Prescription | ORAL |
| 25.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE | Discontinued | ORAL |
| 17MG | TABLET, EXTENDED RELEASE | Prescription | ORAL |
| 8.5MG | TABLET, EXTENDED RELEASE | Prescription | ORAL |