Lotronex is a drug owned by Sebela Ireland Ltd. 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 05, 2018. Details of Lotronex'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). | |||
| US6284770 | Medicaments for the treatment of non-constipated female irritable bowel syndrome |
Oct, 2018
(6 years ago) |
Expired
|
| US5360800 | Tetrahydro-1H-pyrido[4,3-b]indol-1-one derivatives |
Jan, 2013
(11 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Lotronex 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 Lotronex's family patents as well as insights into ongoing legal events on those patents.
Lotronex's Family Patents
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Generic Launch
Generic Release Date:
Lotronex's generic launch date based on the expiry of its last outstanding patent is estimated to be Oct 05, 2018 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Lotronex Generic API suppliers:
Alosetron Hydrochloride is the generic name for the brand Lotronex. 6 different companies have already filed for the generic of Lotronex, with Amneal Pharms having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Lotronex's generic
How can I launch a generic of Lotronex before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Lotronex's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Lotronex'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 Lotronex -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.5 mg and 1 mg | 02 Dec, 2010 | 1 | 04 May, 2015 | 05 Oct, 2018 | Deferred |
About Lotronex
Lotronex is a drug owned by Sebela Ireland Ltd. It is used for treating severe diarrhea-predominant irritable bowel syndrome (IBS) in women. Lotronex uses Alosetron Hydrochloride as an active ingredient. Lotronex was launched by Sebela Ireland Ltd in 2003.
Approval Date:
Lotronex was approved by FDA for market use on 23 December, 2003.
Active Ingredient:
Lotronex uses Alosetron Hydrochloride as the active ingredient. Check out other Drugs and Companies using Alosetron Hydrochloride ingredient
Treatment:
Lotronex is used for treating severe diarrhea-predominant irritable bowel syndrome (IBS) in women.
Dosage:
Lotronex is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 1MG BASE | TABLET | Prescription | ORAL |
| EQ 0.5MG BASE | TABLET | Prescription | ORAL |