Ethyol is a drug owned by Clinigen Inc. It is protected by 3 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 08, 2017. Details of Ethyol'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 active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US5591731 | Crystalline amifostine compositions |
Jul, 2012
(12 years ago) |
Expired
|
| US5424471 | Crystalline amifostine compositions and methods of the preparation and use of same |
Jul, 2012
(12 years ago) |
Expired
|
| US5994409 | Methods for treatment of neuro--and nephro--disorders and therapeutic toxicities using aminothiol compounds |
Dec, 2017
(6 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Ethyol 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 Ethyol's family patents as well as insights into ongoing legal events on those patents.
Ethyol's Family Patents
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Generic Launch
Generic Release Date:
Ethyol's generic launch date based on the expiry of its last outstanding patent is estimated to be Dec 08, 2017 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Ethyol Generics:
Amifostine is the generic name for the brand Ethyol. 2 different companies have already filed for the generic of Ethyol, with Eugia Pharma Speclts having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Ethyol's generic
How can I launch a generic of Ethyol before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Ethyol's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Ethyol'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 Ethyol -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 500 mg/vial | 16 Apr, 2004 | 1 | 14 Mar, 2008 | 31 Jul, 2012 | Eligible |
About Ethyol
Ethyol is a drug owned by Clinigen Inc. It is used for administering the drug product. Ethyol uses Amifostine as an active ingredient. Ethyol was launched by Clinigen in 1999.
Approval Date:
Ethyol was approved by FDA for market use on 10 September, 1999.
Active Ingredient:
Ethyol uses Amifostine as the active ingredient. Check out other Drugs and Companies using Amifostine ingredient
Treatment:
Ethyol is used for administering the drug product.
Dosage:
Ethyol is available in injectable form for injection use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 500MG/VIAL | INJECTABLE | Prescription | INJECTION |
| 375MG/VIAL | INJECTABLE | Discontinued | INJECTION |