Avapro is a drug owned by Sanofi Aventis Us Llc. 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 Dec 07, 2015. Details of Avapro'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). | |||
|
US6342247 (Pediatric) | Pharmaceutical compositions containing irbesartan |
Dec, 2015
(8 years ago) |
Expired
|
| US6342247 | Pharmaceutical compositions containing irbesartan |
Jun, 2015
(9 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Avapro 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 Avapro's family patents as well as insights into ongoing legal events on those patents.
Avapro's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Avapro's generic launch date based on the expiry of its last outstanding patent is estimated to be Dec 07, 2015 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Avapro Generic API suppliers:
Irbesartan is the generic name for the brand Avapro. 22 different companies have already filed for the generic of Avapro, with Ajanta Pharma Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Avapro's generic
How can I launch a generic of Avapro before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Avapro's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Avapro'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 Avapro -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 75 mg, 150 mg and 300 mg | 25 May, 2004 | 1 | 30 Mar, 2012 | 07 Jun, 2015 | Non-Forfeiture |
Alternative Brands for Avapro
There are several other brand drugs using the same active ingredient (Irbesartan) as Avapro. 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 | |
|---|---|---|
| Sanofi Aventis Us |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Irbesartan, Avapro's active ingredient. Check the complete list of approved generic manufacturers for Avapro
About Avapro
Avapro is a drug owned by Sanofi Aventis Us Llc. Avapro uses Irbesartan as an active ingredient. Avapro was launched by Sanofi Aventis Us in 1997.
Approval Date:
Avapro was approved by FDA for market use on 30 September, 1997.
Active Ingredient:
Avapro uses Irbesartan as the active ingredient. Check out other Drugs and Companies using Irbesartan ingredient
Dosage:
Avapro is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 150MG | TABLET | Prescription | ORAL |
| 75MG | TABLET | Discontinued | ORAL |
| 300MG | TABLET | Prescription | ORAL |