Pravachol 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 Oct 22, 2014. Details of Pravachol'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). | |||
|
US5622985 (Pediatric) | Method for preventing a second heart attack employing an HMG CoA reductase inhibitor |
Oct, 2014
(10 years ago) |
Expired
|
| US5622985 | Method for preventing a second heart attack employing an HMG CoA reductase inhibitor |
Apr, 2014
(10 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Pravachol 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 Pravachol's family patents as well as insights into ongoing legal events on those patents.
Pravachol's Family Patents
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Generic Launch
Generic Release Date:
Pravachol's generic launch date based on the expiry of its last outstanding patent is estimated to be Oct 22, 2014 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Pravachol Generic API suppliers:
Pravastatin Sodium is the generic name for the brand Pravachol. 18 different companies have already filed for the generic of Pravachol, with Norvium Bioscience having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Pravachol's generic
How can I launch a generic of Pravachol before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Pravachol's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Pravachol'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 Pravachol -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 10 mg, 20 mg, 40 mg and 80 mg | |||||
| 30 mg | 01 Jun, 2005 | 1 | 28 Nov, 2006 | 22 Apr, 2014 | Eligible |
Alternative Brands for Pravachol
Pravachol which is used for secondary prevention of coronary events in patients with a history of myocardial infarction and normal cholesterol levels., has several other brand drugs in the same treatment category and using the same active ingredient (Pravastatin Sodium). 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 | Treatment Area | ||
|---|---|---|---|---|
| Bristol Myers Squibb |
| |||
Apart from brand drugs containing the same ingredient, some generics have also been filed for Pravastatin Sodium, Pravachol's active ingredient. Check the complete list of approved generic manufacturers for Pravachol
About Pravachol
Pravachol is a drug owned by Bristol Myers Squibb. It is used for secondary prevention of coronary events in patients with a history of myocardial infarction and normal cholesterol levels. Pravachol uses Pravastatin Sodium as an active ingredient. Pravachol was launched by Bristol Myers Squibb in 1991.
Approval Date:
Pravachol was approved by FDA for market use on 31 October, 1991.
Active Ingredient:
Pravachol uses Pravastatin Sodium as the active ingredient. Check out other Drugs and Companies using Pravastatin Sodium ingredient
Treatment:
Pravachol is used for secondary prevention of coronary events in patients with a history of myocardial infarction and normal cholesterol levels.
Dosage:
Pravachol is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |
| 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |
| 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |
| 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |