Lescol Xl is a drug owned by Sandoz Inc. 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 Oct 13, 2020. Details of Lescol Xl'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). | |||
|
US6242003 (Pediatric) | Organic compounds |
Oct, 2020
(4 years ago) |
Expired
|
| US6242003 | Organic compounds |
Apr, 2020
(4 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Lescol Xl 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 Lescol Xl's family patents as well as insights into ongoing legal events on those patents.
Lescol Xl's Family Patents
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Generic Launch
Generic Release Date:
Lescol Xl's generic launch date based on the expiry of its last outstanding patent is estimated to be Oct 13, 2020 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Lescol Xl Generic API suppliers:
Fluvastatin Sodium is the generic name for the brand Lescol Xl. 5 different companies have already filed for the generic of Lescol Xl, with Mylan Pharms Inc having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Lescol Xl's generic
How can I launch a generic of Lescol Xl before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Lescol Xl's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Lescol Xl'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 Lescol Xl -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 80 mg | 15 Mar, 2007 | 1 | 13 Apr, 2020 | Extinguished |
About Lescol Xl
Lescol Xl is a drug owned by Sandoz Inc. Lescol Xl uses Fluvastatin Sodium as an active ingredient. Lescol Xl was launched by Sandoz in 2000.
Approval Date:
Lescol Xl was approved by FDA for market use on 06 October, 2000.
Active Ingredient:
Lescol Xl uses Fluvastatin Sodium as the active ingredient. Check out other Drugs and Companies using Fluvastatin Sodium ingredient
Dosage:
Lescol Xl is available in tablet, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 80MG BASE | TABLET, EXTENDED RELEASE | Prescription | ORAL |