Robinul is a drug owned by Casper Pharma Llc. It is protected by 1 US drug patent filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 24, 2024. Details of Robinul'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). | |||
| US7091236 | Method for increasing the bioavailability of glycopyrrolate |
Apr, 2024
(7 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 Robinul's patents.
Latest Legal Activities on Robinul's Patents
Given below is the list of recent legal activities going on the following patents of Robinul.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 09 Feb, 2018 | US7091236 (Litigated) |
| Change in Power of Attorney (May Include Associate POA) Critical | 13 Dec, 2012 | US7091236 (Litigated) |
| Email Notification Critical | 13 Dec, 2012 | US7091236 (Litigated) |
| Correspondence Address Change Critical | 12 Dec, 2012 | US7091236 (Litigated) |
| Change in Power of Attorney (May Include Associate POA) Critical | 30 Aug, 2011 | US7091236 (Litigated) |
| Email Notification Critical | 30 Aug, 2011 | US7091236 (Litigated) |
| Correspondence Address Change Critical | 26 Aug, 2011 | US7091236 (Litigated) |
| Patent Issue Date Used in PTA Calculation Critical | 15 Aug, 2006 | US7091236 (Litigated) |
| Recordation of Patent Grant Mailed Critical | 15 Aug, 2006 | US7091236 (Litigated) |
| Issue Notification Mailed Critical | 26 Jul, 2006 | US7091236 (Litigated) |
US patents provide insights into the exclusivity only within the United States, but Robinul 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 Robinul's family patents as well as insights into ongoing legal events on those patents.
Robinul's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Robinul's generic launch date based on the expiry of its last outstanding patent is estimated to be Apr 24, 2024 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Robinul Generic API suppliers:
Glycopyrrolate is the generic name for the brand Robinul. 44 different companies have already filed for the generic of Robinul, with Watson Labs having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Robinul's generic
How can I launch a generic of Robinul before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Robinul's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Robinul'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 Robinul -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 1 mg | 14 Aug, 2009 | 1 | 03 Feb, 2014 | 24 Apr, 2024 | Extinguished |
| 2 mg | 12 Oct, 2010 | 1 | 03 Feb, 2014 | 24 Apr, 2024 | Eligible |
Alternative Brands for Robinul
Robinul which is used for supporting treatment of peptic ulcers., has several other brand drugs in the same treatment category and using the same active ingredient (Glycopyrrolate). 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 | Treatment Area | ||
|---|---|---|---|---|
| Casper Pharma Llc |
| |||
Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Glycopyrrolate. Given below is the list of those drugs and companies owning them.
| Drug Owner | Drug Name | ||
|---|---|---|---|
| Astrazeneca |
| ||
| Astrazeneca Ab |
| ||
| Azurity |
| ||
| Merz Pharms |
| ||
| Novartis |
| ||
| Sumitomo Pharma Am |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Glycopyrrolate, Robinul's active ingredient. Check the complete list of approved generic manufacturers for Robinul
About Robinul
Robinul is a drug owned by Casper Pharma Llc. It is used for supporting treatment of peptic ulcers. Robinul uses Glycopyrrolate as an active ingredient. Robinul was launched by Casper Pharma Llc in 1982.
Approval Date:
Robinul was approved by FDA for market use on 01 January, 1982.
Active Ingredient:
Robinul uses Glycopyrrolate as the active ingredient. Check out other Drugs and Companies using Glycopyrrolate ingredient
Treatment:
Robinul is used for supporting treatment of peptic ulcers.
Dosage:
Robinul is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Prescription | ORAL |