Evoxac is a drug owned by Cosette 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 Jul 07, 2013. Details of Evoxac'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). | |||
| US5340821 | Composition and method for treating Sjoegren syndrome disease |
Jul, 2013
(11 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Evoxac 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 Evoxac's family patents as well as insights into ongoing legal events on those patents.
Evoxac's Family Patents
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Generic Launch
Generic Release Date:
Evoxac's generic launch date based on the expiry of its last outstanding patent is estimated to be Jul 07, 2013 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Evoxac Generic API suppliers:
Cevimeline Hydrochloride is the generic name for the brand Evoxac. 8 different companies have already filed for the generic of Evoxac, with Apotex Inc having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Evoxac's generic
How can I launch a generic of Evoxac before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Evoxac's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Evoxac'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 Evoxac -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 30 mg | 27 Feb, 2009 | 1 | 07 Jul, 2013 | Extinguished |
About Evoxac
Evoxac is a drug owned by Cosette Pharmaceuticals Inc. It is used for managing symptoms of Sjögren's syndrome. Evoxac uses Cevimeline Hydrochloride as an active ingredient. Evoxac was launched by Cosette in 2000.
Approval Date:
Evoxac was approved by FDA for market use on 11 January, 2000.
Active Ingredient:
Evoxac uses Cevimeline Hydrochloride as the active ingredient. Check out other Drugs and Companies using Cevimeline Hydrochloride ingredient
Treatment:
Evoxac is used for managing symptoms of Sjögren's syndrome.
Dosage:
Evoxac is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 30MG | CAPSULE | Prescription | ORAL |