Women's Rogaine is a drug owned by Johnson And Johnson Group Consumer Companies. It is protected by 1 US drug patent filed in 2015 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 20, 2019. Details of Women's Rogaine'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). | |||
| US6946120 | Pharmaceutical composition |
Apr, 2019
(5 years ago) |
Expired
|
FDA has granted several exclusivities to Women's Rogaine. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Women's Rogaine, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Women's Rogaine.
Exclusivity Information
Women's Rogaine holds 1 exclusivities. All of its exclusivities have expired in 2017. Details of Women's Rogaine's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Feb 28, 2017 |
US patents provide insights into the exclusivity only within the United States, but Women's Rogaine 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 Women's Rogaine's family patents as well as insights into ongoing legal events on those patents.
Women's Rogaine's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Women's Rogaine's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 20, 2019 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Women's Rogaine Generics:
There are no approved generic versions for Women's Rogaine as of now.
How can I launch a generic of Women's Rogaine before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Women's Rogaine's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Women's Rogaine'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 Women's Rogaine -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.05 | 06 Apr, 2009 | 1 | 28 Apr, 2011 | 20 Apr, 2019 | Eligible |
| 0.05 | 04 Feb, 2015 | 1 | 27 Jul, 2017 | 20 Apr, 2019 | Eligible |
About Women's Rogaine
Women'S Rogaine is a drug owned by Johnson And Johnson Group Consumer Companies. It is used for promoting hair regrowth in patients with hair loss. Women'S Rogaine uses Minoxidil as an active ingredient. Women'S Rogaine was launched by Johnson And Johnson in 2006.
Approval Date:
Women's Rogaine was approved by FDA for market use on 20 January, 2006.
Active Ingredient:
Women's Rogaine uses Minoxidil as the active ingredient. Check out other Drugs and Companies using Minoxidil ingredient
Treatment:
Women's Rogaine is used for promoting hair regrowth in patients with hair loss.
Dosage:
Women's Rogaine is available in aerosol, foam form for topical use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 5% | AEROSOL, FOAM | Over the counter | TOPICAL |