Axert is a drug owned by Janssen Pharmaceuticals Inc. 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 Nov 07, 2015. Details of Axert'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). | |||
|
US5565447 (Pediatric) | Indole derivatives |
Nov, 2015
(9 years ago) |
Expired
|
| US5565447 | Indole derivatives |
May, 2015
(9 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Axert 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 Axert's family patents as well as insights into ongoing legal events on those patents.
Axert's Family Patents
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Generic Launch
Generic Release Date:
Axert's generic launch date based on the expiry of its last outstanding patent is estimated to be Nov 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)
Axert Generic API suppliers:
Almotriptan Malate is the generic name for the brand Axert. 3 different companies have already filed for the generic of Axert, with Ajanta Pharma Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Axert's generic
How can I launch a generic of Axert before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Axert's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Axert'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 Axert -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 6.25 mg and 12.5 mg | 08 Dec, 2005 | 1 | 07 Jul, 2015 | 07 May, 2015 | Extinguished |
About Axert
Axert is a drug owned by Janssen Pharmaceuticals Inc. It is used for relieving symptoms of migraines. Axert uses Almotriptan Malate as an active ingredient. Axert was launched by Janssen Pharms in 2001.
Approval Date:
Axert was approved by FDA for market use on 07 May, 2001.
Active Ingredient:
Axert uses Almotriptan Malate as the active ingredient. Check out other Drugs and Companies using Almotriptan Malate ingredient
Treatment:
Axert is used for relieving symptoms of migraines.
Dosage:
Axert is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 12.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |
| EQ 6.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |