Aggrenox is a drug owned by Boehringer Ingelheim Pharmaceuticals Inc. 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 Jan 18, 2017. Details of Aggrenox'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). | |||
| US6015577 | Pharmaceutical compositions containing dipyridamole or mopidamol and acetylsalicylic acid or the physiologically acceptable salts thereof, processes for preparing them and their use in treating clot formation |
Jan, 2017
(7 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Aggrenox 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 Aggrenox's family patents as well as insights into ongoing legal events on those patents.
Aggrenox's Family Patents
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Generic Launch
Generic Release Date:
Aggrenox's generic launch date based on the expiry of its last outstanding patent is estimated to be Jan 18, 2017 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Aggrenox Generic API suppliers:
Aspirin; Dipyridamole is the generic name for the brand Aggrenox. 11 different companies have already filed for the generic of Aggrenox, with Amneal Pharms having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Aggrenox's generic
How can I launch a generic of Aggrenox before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Aggrenox's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Aggrenox'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 Aggrenox -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 25 mg and 200 mg | 01 Feb, 2007 | 1 | 14 Aug, 2009 | 18 Jan, 2017 | Deferred |
About Aggrenox
Aggrenox is a drug owned by Boehringer Ingelheim Pharmaceuticals Inc. It is used for reducing the risk of stroke in patients with previous transient ischemic attacks or ischemic strokes caused by thrombosis. Aggrenox uses Aspirin; Dipyridamole as an active ingredient. Aggrenox was launched by Boehringer Ingelheim in 1999.
Approval Date:
Aggrenox was approved by FDA for market use on 22 November, 1999.
Active Ingredient:
Aggrenox uses Aspirin; Dipyridamole as the active ingredient. Check out other Drugs and Companies using Aspirin; Dipyridamole ingredient
Treatment:
Aggrenox is used for reducing the risk of stroke in patients with previous transient ischemic attacks or ischemic strokes caused by thrombosis.
Dosage:
Aggrenox is available in capsule, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 25MG;200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE | Discontinued | ORAL |