Jalyn is a drug owned by Waylis Therapeutics Llc. It is protected by 3 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 Nov 20, 2015. Details of Jalyn'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). | |||
| US5565467 | Androstenone derivative |
Nov, 2015
(9 years ago) |
Expired
|
| US5998427 | Androstenones |
Sep, 2013
(11 years ago) |
Expired
|
| US5846976 | Androstenone derivative |
Sep, 2013
(11 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Jalyn 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 Jalyn's family patents as well as insights into ongoing legal events on those patents.
Jalyn's Family Patents
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Generic Launch
Generic Release Date:
Jalyn's generic launch date based on the expiry of its last outstanding patent is estimated to be Nov 20, 2015 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Jalyn Generic API suppliers:
Dutasteride; Tamsulosin Hydrochloride is the generic name for the brand Jalyn. 4 different companies have already filed for the generic of Jalyn, with Actavis Labs Fl Inc having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Jalyn's generic
How can I launch a generic of Jalyn before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Jalyn's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Jalyn'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 Jalyn -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.5 mg/0.4 mg | 26 Oct, 2010 | 1 | 26 Feb, 2014 | 20 Nov, 2015 | Eligible |
About Jalyn
Jalyn is a drug owned by Waylis Therapeutics Llc. It is used for treating benign prostatic hyperplasia and other androgen responsive or mediated conditions in mammals with Dutasteride. Jalyn uses Dutasteride; Tamsulosin Hydrochloride as an active ingredient. Jalyn was launched by Waylis Therap in 2010.
Approval Date:
Jalyn was approved by FDA for market use on 14 June, 2010.
Active Ingredient:
Jalyn uses Dutasteride; Tamsulosin Hydrochloride as the active ingredient. Check out other Drugs and Companies using Dutasteride; Tamsulosin Hydrochloride ingredient
Treatment:
Jalyn is used for treating benign prostatic hyperplasia and other androgen responsive or mediated conditions in mammals with Dutasteride.
Dosage:
Jalyn is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.5MG;0.4MG | CAPSULE | Prescription | ORAL |