Glucovance is a drug owned by Bristol Myers Squibb. 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 Jan 14, 2020. Details of Glucovance'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). | |||
|
US6303146 (Pediatric) | Solid oral dosage form comprising a combination of metformin and glibenclamide |
Jan, 2020
(4 years ago) |
Expired
|
| US6303146 | Solid oral dosage form comprising a combination of metformin and glibenclamide |
Jul, 2019
(5 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Glucovance 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 Glucovance's family patents as well as insights into ongoing legal events on those patents.
Glucovance's Family Patents
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Generic Launch
Generic Release Date:
Glucovance's generic launch date based on the expiry of its last outstanding patent is estimated to be Jan 14, 2020 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Glucovance Generic API suppliers:
Glyburide; Metformin Hydrochloride is the generic name for the brand Glucovance. 6 different companies have already filed for the generic of Glucovance, with Impax Labs Inc having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Glucovance's generic
How can I launch a generic of Glucovance before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Glucovance's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Glucovance'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 Glucovance -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 1.25mg/250 mg 2.5 mg/500 mg 5 mg/500 mg |
About Glucovance
Glucovance is a drug owned by Bristol Myers Squibb. It is used for managing blood sugar levels in individuals with type 2 diabetes. Glucovance uses Glyburide; Metformin Hydrochloride as an active ingredient. Glucovance was launched by Bristol Myers Squibb in 2000.
Approval Date:
Glucovance was approved by FDA for market use on 31 July, 2000.
Active Ingredient:
Glucovance uses Glyburide; Metformin Hydrochloride as the active ingredient. Check out other Drugs and Companies using Glyburide; Metformin Hydrochloride ingredient
Treatment:
Glucovance is used for managing blood sugar levels in individuals with type 2 diabetes.
Dosage:
Glucovance is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 1.25MG;250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |
| 2.5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |
| 5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |