Nitrostat is a drug owned by Viatris Specialty 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 Sep 16, 2018. Details of Nitrostat'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). | |||
| US6500456 | Compressed nitroglycerin tablet and its method of manufacture |
Sep, 2018
(6 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Nitrostat 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 Nitrostat's family patents as well as insights into ongoing legal events on those patents.
Nitrostat's Family Patents
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Generic Launch
Generic Release Date:
Nitrostat's generic launch date based on the expiry of its last outstanding patent is estimated to be Sep 16, 2018 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Nitrostat Generic API suppliers:
Nitroglycerin is the generic name for the brand Nitrostat. 27 different companies have already filed for the generic of Nitrostat, with Mylan Technologies having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Nitrostat's generic
How can I launch a generic of Nitrostat before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Nitrostat's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Nitrostat'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 Nitrostat -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.3 mg, 0.4 mg, and 0.6 mg | 19 Oct, 2005 | 1 | 16 Sep, 2018 | Extinguished |
Alternative Brands for Nitrostat
There are several other brand drugs using the same active ingredient (Nitroglycerin) as Nitrostat. 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 | ||
|---|---|---|---|
| Abbvie |
| ||
| Evus |
| ||
| Pohl Boskamp |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Nitroglycerin, Nitrostat's active ingredient. Check the complete list of approved generic manufacturers for Nitrostat
About Nitrostat
Nitrostat is a drug owned by Viatris Specialty Llc. Nitrostat uses Nitroglycerin as an active ingredient. Nitrostat was launched by Viatris in 2000.
Approval Date:
Nitrostat was approved by FDA for market use on 01 May, 2000.
Active Ingredient:
Nitrostat uses Nitroglycerin as the active ingredient. Check out other Drugs and Companies using Nitroglycerin ingredient
Dosage:
Nitrostat is available in tablet form for sublingual use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.3MG | TABLET | Prescription | SUBLINGUAL |
| 0.4MG | TABLET | Prescription | SUBLINGUAL |
| 0.6MG | TABLET | Prescription | SUBLINGUAL |