Ditropan Xl is a drug owned by Janssen Pharmaceuticals Inc. It is protected by 8 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 22, 2015. Details of Ditropan 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). | |||
|
US5840754 (Pediatric) | Dosage form comprising oxybutynin |
Nov, 2015
(9 years ago) |
Expired
|
|
US5674895 (Pediatric) | Dosage form comprising oxybutynin |
Nov, 2015
(9 years ago) |
Expired
|
|
US6262115 (Pediatric) | Method for the management of incontinence |
Nov, 2015
(9 years ago) |
Expired
|
|
US5912268 (Pediatric) | Dosage form and method for treating incontinence |
Nov, 2015
(9 years ago) |
Expired
|
| US6262115 | Method for the management of incontinence |
May, 2015
(9 years ago) |
Expired
|
| US5912268 | Dosage form and method for treating incontinence |
May, 2015
(9 years ago) |
Expired
|
| US5674895 | Dosage form comprising oxybutynin |
May, 2015
(9 years ago) |
Expired
|
| US5840754 | Dosage form comprising oxybutynin |
May, 2015
(9 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Ditropan 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 Ditropan Xl's family patents as well as insights into ongoing legal events on those patents.
Ditropan Xl's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Ditropan Xl's generic launch date based on the expiry of its last outstanding patent is estimated to be Nov 22, 2015 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Ditropan Xl Generic API suppliers:
Oxybutynin Chloride is the generic name for the brand Ditropan Xl. 29 different companies have already filed for the generic of Ditropan Xl, with Bionpharma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Ditropan Xl's generic
How can I launch a generic of Ditropan Xl before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Ditropan Xl's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Ditropan 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 Ditropan Xl -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 5 mg, 10 mg and 15 mg |
Alternative Brands for Ditropan Xl
Ditropan Xl which is used for managing incontinence, hormone replacement therapy, treating involuntary incontinence, managing overactive bladder, and increasing compliance in patients., has several other brand drugs using the same active ingredient (Oxybutynin Chloride). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | |
|---|---|---|
| Abbvie |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Oxybutynin Chloride, Ditropan Xl's active ingredient. Check the complete list of approved generic manufacturers for Ditropan Xl
About Ditropan Xl
Ditropan Xl is a drug owned by Janssen Pharmaceuticals Inc. It is used for managing incontinence, hormone replacement therapy, treating involuntary incontinence, managing overactive bladder, and increasing compliance in patients. Ditropan Xl uses Oxybutynin Chloride as an active ingredient. Ditropan Xl was launched by Janssen Pharms in 1998.
Approval Date:
Ditropan Xl was approved by FDA for market use on 16 December, 1998.
Active Ingredient:
Ditropan Xl uses Oxybutynin Chloride as the active ingredient. Check out other Drugs and Companies using Oxybutynin Chloride ingredient
Treatment:
Ditropan Xl is used for managing incontinence, hormone replacement therapy, treating involuntary incontinence, managing overactive bladder, and increasing compliance in patients.
Dosage:
Ditropan Xl is available in tablet, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE | Discontinued | ORAL |
| 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE | Discontinued | ORAL |
| 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE | Discontinued | ORAL |