Enablex is a drug owned by Abbvie 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 Aug 21, 2016. Details of Enablex'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). | |||
| US6106864 | Pharmaceutical formulations containing darifenacin |
Aug, 2016
(8 years ago) |
Expired
|
| US5096890 | Pyrrolidine derivatives |
Mar, 2015
(9 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Enablex 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 Enablex's family patents as well as insights into ongoing legal events on those patents.
Enablex's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Enablex's generic launch date based on the expiry of its last outstanding patent is estimated to be Aug 21, 2016 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Enablex Generic API suppliers:
Darifenacin Hydrobromide is the generic name for the brand Enablex. 9 different companies have already filed for the generic of Enablex, with Alembic having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Enablex's generic
How can I launch a generic of Enablex before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Enablex's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Enablex'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 Enablex -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 7.5 mg and 15 mg | 22 Dec, 2008 | 3 | 13 Mar, 2015 | 21 Aug, 2016 | Deferred |
About Enablex
Enablex is a drug owned by Abbvie Inc. It is used for treating a disease of altered motility or tone of smooth muscle and urinary incontinence. Enablex uses Darifenacin Hydrobromide as an active ingredient. Enablex was launched by Abbvie in 2004.
Approval Date:
Enablex was approved by FDA for market use on 22 December, 2004.
Active Ingredient:
Enablex uses Darifenacin Hydrobromide as the active ingredient. Check out other Drugs and Companies using Darifenacin Hydrobromide ingredient
Treatment:
Enablex is used for treating a disease of altered motility or tone of smooth muscle and urinary incontinence.
Dosage:
Enablex is available in tablet, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE | Discontinued | ORAL |
| EQ 7.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE | Discontinued | ORAL |