Glucotrol Xl is a drug owned by Pfizer 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 Mar 26, 2019. Details of Glucotrol 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). | |||
| USRE44459 | Method for lowering blood glucose |
Mar, 2019
(7 years ago) |
Expired
|
| US5591454 | Method for lowering blood glucose |
Jan, 2014
(12 years 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 Glucotrol Xl's patents.
Latest Legal Activities on Glucotrol Xl's Patents
Given below is the list of recent legal activities going on the following patents of Glucotrol Xl.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Termination or Final Written Decision | 08 Sep, 2014 | USRE44459 |
| Petition Requesting Trial | 30 May, 2014 | USRE44459 |
| Recordation of Patent Grant Mailed | 27 Aug, 2013 | USRE44459 |
| Email Notification | 08 Aug, 2013 | USRE44459 |
| Issue Notification Mailed | 07 Aug, 2013 | USRE44459 |
| Dispatch to FDC | 29 Jul, 2013 | USRE44459 |
| Application Is Considered Ready for Issue | 14 May, 2013 | USRE44459 |
| Issue Fee Payment Verified | 10 May, 2013 | USRE44459 |
| Issue Fee Payment Received | 10 May, 2013 | USRE44459 |
| Email Notification | 15 Apr, 2013 | USRE44459 |
US patents provide insights into the exclusivity only within the United States, but
Glucotrol 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 Glucotrol Xl's family patents as well as insights into
ongoing legal events
on those patents.
Glucotrol Xl's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Glucotrol Xl's generic launch date based on the expiry of its last outstanding patent is estimated to be Mar 26, 2019 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Glucotrol Xl Generic API suppliers:
Glipizide is the generic name for the brand Glucotrol Xl. 18 different companies have already filed for the generic of Glucotrol Xl, with Watson Labs having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Glucotrol Xl's generic
How can I launch a generic of Glucotrol Xl before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Glucotrol Xl's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Glucotrol 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 Glucotrol Xl -
| Strength | Submission Date | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| None |
About Glucotrol Xl
Glucotrol Xl is a drug owned by Pfizer Inc. It is used for managing hyperglycemia in diabetes through oral administration of a once-a-day sustained release dosage form of Glipizide. Glucotrol Xl uses Glipizide as an active ingredient. Glucotrol Xl was launched by Pfizer in 1994.
Approval Date:
Glucotrol Xl was approved by FDA for market use on 26 April, 1994.
Active Ingredient:
Glucotrol Xl uses Glipizide as the active ingredient. Check out other Drugs and Companies using Glipizide ingredient
Treatment:
Glucotrol Xl is used for managing hyperglycemia in diabetes through oral administration of a once-a-day sustained release dosage form of Glipizide.
Dosage:
Glucotrol 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 | TABLET, EXTENDED RELEASE | Prescription | ORAL |
| 10MG | TABLET, EXTENDED RELEASE | Prescription | ORAL |
| 2.5MG | TABLET, EXTENDED RELEASE | Discontinued | ORAL |