Avalide 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 Avalide'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). | |||
|
US5994348 (Pediatric) | Pharmaceutical compositions containing irbesartan |
Dec, 2015
(8 years ago) |
Expired
|
| US5994348 | Pharmaceutical compositions containing irbesartan |
Jun, 2015
(9 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Avalide 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 Avalide's family patents as well as insights into ongoing legal events on those patents.
Avalide's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Avalide'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)
Avalide Generic API suppliers:
Hydrochlorothiazide; Irbesartan is the generic name for the brand Avalide. 15 different companies have already filed for the generic of Avalide, with Norvium Bioscience having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Avalide's generic
How can I launch a generic of Avalide before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Avalide's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Avalide'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 Avalide -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 150 mg/12.5 mg and 300 mg/12.5 mg | 10 Nov, 2004 | 1 | 30 Mar, 2012 | 07 Jun, 2015 | Eligible |
| 300 mg/25 mg | 06 Jun, 2006 | 1 | 30 Mar, 2012 | 07 Jun, 2015 | Eligible |
About Avalide
Avalide is a drug owned by Sanofi Aventis Us Llc. Avalide uses Hydrochlorothiazide; Irbesartan as an active ingredient. Avalide was launched by Sanofi Aventis Us in 1997.
Approval Date:
Avalide was approved by FDA for market use on 30 September, 1997.
Active Ingredient:
Avalide uses Hydrochlorothiazide; Irbesartan as the active ingredient. Check out other Drugs and Companies using Hydrochlorothiazide; Irbesartan ingredient
Dosage:
Avalide is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 12.5MG;75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |
| 12.5MG;150MG | TABLET | Prescription | ORAL |
| 12.5MG;300MG | TABLET | Prescription | ORAL |
| 25MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |