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
(5 years ago) |
Expired
|
| US5591454 | Method for lowering blood glucose |
Jan, 2014
(10 years ago) |
Expired
|
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
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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. 17 different companies have already filed for the generic of Glucotrol Xl, with Norvium Bioscience 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 | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 2.5 mg, 5 mg and 10 mg |
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 1999.
Approval Date:
Glucotrol Xl was approved by FDA for market use on 10 August, 1999.
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 | Prescription | ORAL |