Sanctura Xr is a drug owned by Allergan Inc. It is protected by 5 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 Feb 01, 2025. Details of Sanctura Xr'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). | |||
| US7410978 | Once daily dosage forms of trospium |
Feb, 2025
(1 year, 8 months ago) |
Expired
|
| US7781449 | Trospium chloride treatment method |
Nov, 2024
(1 year, 10 months ago) |
Expired
|
| US7781448 | Once daily dosage forms of trospium |
Nov, 2024
(1 year, 10 months ago) |
Expired
|
| US7759359 | Method of treating bladder dysfunction with once-a-day trospium salt formulation |
Nov, 2024
(1 year, 10 months ago) |
Expired
|
| US7763635 | Once daily dosage forms of trospium |
Nov, 2024
(1 year, 10 months ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical
activities like
abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease
the life of a
patent hence affecting its expiry date and in turn affecting the generic launch date of that drug.
Tracking these
ongoing activities on a patent application helps to keep an eye on the latest developments in the
patent process of
the drug which can give an idea of how early a drug's generic could be available. The next section
provides a list of
recent legal activities on Sanctura Xr's patents.
Latest Legal Activities on Sanctura Xr's Patents
Given below is the list of recent legal activities going on the following patents of Sanctura Xr.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent
Critical | 01 Oct, 2018 | US7781449 (Litigated) |
| Expire Patent
Critical | 01 Oct, 2018 | US7781448 (Litigated) |
| Expire Patent
Critical | 03 Sep, 2018 | US7763635 (Litigated) |
| Expire Patent
Critical | 27 Aug, 2018 | US7759359 (Litigated) |
| Maintenance Fee Reminder Mailed
Critical | 09 Apr, 2018 | US7781449 (Litigated) |
| Maintenance Fee Reminder Mailed
Critical | 09 Apr, 2018 | US7781448 (Litigated) |
| Maintenance Fee Reminder Mailed
Critical | 12 Mar, 2018 | US7763635 (Litigated) |
| Maintenance Fee Reminder Mailed
Critical | 05 Mar, 2018 | US7759359 (Litigated) |
| Expire Patent
Critical | 09 Sep, 2016 | US7410978 (Litigated) |
| Change in Power of Attorney (May Include Associate POA)
Critical | 27 Apr, 2015 | US7759359 (Litigated) |
US patents provide insights into the exclusivity only within the United States, but
Sanctura Xr 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 Sanctura Xr's family patents as well as insights into
ongoing legal events
on those patents.
Sanctura Xr's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Sanctura Xr:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
Generic Launch
Generic Release Date:
Sanctura Xr's generic launch date based on the expiry of its last outstanding patent is estimated to be Feb 01, 2025 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Sanctura Xr Generic API suppliers:
Trospium Chloride is the generic name for the brand Sanctura Xr. 11 different companies have already filed for the generic of Sanctura Xr, with Padagis Us having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Sanctura Xr's generic
How can I launch a generic of Sanctura Xr before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Sanctura Xr's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Sanctura Xr'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 Sanctura Xr -
| Strength | Submission Date | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| 02 Mar, 2009 | 01 Feb, 2025 | Deferred | 12 Oct, 2012 | Less |
Alternative Brands for Sanctura Xr
Sanctura Xr which is used for treating bladder dysfunction., has several other brand drugs using the same active ingredient (Trospium 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 | |
|---|---|---|
| Bristol-myers |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Trospium Chloride, Sanctura Xr's active ingredient. Check the complete list of approved generic manufacturers for Sanctura Xr
About Sanctura Xr
Sanctura Xr is a drug owned by Allergan Inc. It is used for treating bladder dysfunction. Sanctura Xr uses Trospium Chloride as an active ingredient. Sanctura Xr was launched by Allergan in 2007.
Approval Date:
Sanctura Xr was approved by FDA for market use on 03 August, 2007.
Active Ingredient:
Sanctura Xr uses Trospium Chloride as the active ingredient. Check out other Drugs and Companies using Trospium Chloride ingredient
Treatment:
Sanctura Xr is used for treating bladder dysfunction.
Dosage:
Sanctura Xr is available in capsule, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE | Discontinued | ORAL |