Rythmol Sr is a drug owned by Glaxosmithkline Llc. 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 Oct 28, 2014. Details of Rythmol Sr'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). | |||
| US5681588 | Delayed release microtablet of β-phenylpropiophenone derivatives |
Oct, 2014
(10 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Rythmol Sr 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 Rythmol Sr's family patents as well as insights into ongoing legal events on those patents.
Rythmol Sr's Family Patents
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Generic Launch
Generic Release Date:
Rythmol Sr's generic launch date based on the expiry of its last outstanding patent is estimated to be Oct 28, 2014 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Rythmol Sr Generic API suppliers:
Propafenone Hydrochloride is the generic name for the brand Rythmol Sr. 15 different companies have already filed for the generic of Rythmol Sr, with Strides Pharma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Rythmol Sr's generic
How can I launch a generic of Rythmol Sr before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Rythmol Sr's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Rythmol Sr'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 Rythmol Sr -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 325 mg | 07 Nov, 2006 | 1 | 18 Oct, 2010 | 28 Oct, 2014 | Deferred |
| 225 mg and 425 mg | 11 Oct, 2006 | 1 | 18 Oct, 2010 | 28 Oct, 2014 | Deferred |
About Rythmol Sr
Rythmol Sr is a drug owned by Glaxosmithkline Llc. Rythmol Sr uses Propafenone Hydrochloride as an active ingredient. Rythmol Sr was launched by Glaxosmithkline Llc in 2003.
Approval Date:
Rythmol Sr was approved by FDA for market use on 04 September, 2003.
Active Ingredient:
Rythmol Sr uses Propafenone Hydrochloride as the active ingredient. Check out other Drugs and Companies using Propafenone Hydrochloride ingredient
Dosage:
Rythmol Sr is available in capsule, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 225MG | CAPSULE, EXTENDED RELEASE | Discontinued | ORAL |
| 325MG | CAPSULE, EXTENDED RELEASE | Discontinued | ORAL |
| 425MG | CAPSULE, EXTENDED RELEASE | Discontinued | ORAL |