Prandin is a drug owned by Gemini Laboratories 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 Jun 12, 2018. Details of Prandin'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 Prandin 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 Prandin's family patents as well as insights into ongoing legal events on those patents.
Prandin's Family Patents
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Generic Launch
Generic Release Date:
Prandin'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)
Prandin Generic API suppliers:
Repaglinide is the generic name for the brand Prandin. 8 different companies have already filed for the generic of Prandin, with Actavis Totowa having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Prandin's generic
How can I launch a generic of Prandin before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Prandin's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Prandin'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 Prandin -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.5 mg*, 1 mg and 2 mg | 10 Feb, 2005 | 1 | 11 Jul, 2013 | 12 Jun, 2018 | Eligible |
Alternative Brands for Prandin
Prandin which is used for improving glycemic control in adults with type 2 diabetes mellitus., has several other brand drugs using the same active ingredient (Repaglinide). 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 | |
|---|---|---|
| Novo Nordisk Inc |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Repaglinide, Prandin's active ingredient. Check the complete list of approved generic manufacturers for Prandin
About Prandin
Prandin is a drug owned by Gemini Laboratories Llc. It is used for improving glycemic control in adults with type 2 diabetes mellitus. Prandin uses Repaglinide as an active ingredient. Prandin was launched by Gemini Labs Llc in 1997.
Approval Date:
Prandin was approved by FDA for market use on 22 December, 1997.
Active Ingredient:
Prandin uses Repaglinide as the active ingredient. Check out other Drugs and Companies using Repaglinide ingredient
Treatment:
Prandin is used for improving glycemic control in adults with type 2 diabetes mellitus.
Dosage:
Prandin is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |
| 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |
| 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |