Prandimet is a drug owned by Novo Nordisk Inc. 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 Jun 12, 2018. Details of Prandimet'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). | |||
| US6677358 | NIDDM regimen |
Jun, 2018
(6 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Prandimet 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 Prandimet's family patents as well as insights into ongoing legal events on those patents.
Prandimet's Family Patents
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Generic Launch
Generic Release Date:
Prandimet's generic launch date based on the expiry of its last outstanding patent is estimated to be Jun 12, 2018 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Prandimet Generic API suppliers:
Metformin Hydrochloride; Repaglinide is the generic name for the brand Prandimet. 1 company has already filed for the generic of Prandimet. Check out the entire list of companies who have already received approval for Prandimet's generic
How can I launch a generic of Prandimet before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Prandimet's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Prandimet'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 Prandimet -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 1 mg/500 mg and 2 mg/500 mg | 09 Apr, 2009 | 1 | 12 Jun, 2018 | Extinguished |
About Prandimet
Prandimet is a drug owned by Novo Nordisk Inc. It is used for managing blood glucose levels in patients with diabetes. Prandimet uses Metformin Hydrochloride; Repaglinide as an active ingredient. Prandimet was launched by Novo Nordisk Inc in 2008.
Approval Date:
Prandimet was approved by FDA for market use on 23 June, 2008.
Active Ingredient:
Prandimet uses Metformin Hydrochloride; Repaglinide as the active ingredient. Check out other Drugs and Companies using Metformin Hydrochloride; Repaglinide ingredient
Treatment:
Prandimet is used for managing blood glucose levels in patients with diabetes.
Dosage:
Prandimet is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 500MG;1MG | TABLET | Discontinued | ORAL |
| 500MG;2MG | TABLET | Discontinued | ORAL |