Tikosyn is a drug owned by Pfizer Pharmaceuticals Production Corp Ltd. 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 Oct 09, 2018. Details of Tikosyn'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). | |||
| US6124363 | Dofetilide polymorphs |
Oct, 2018
(6 years ago) |
Expired
|
| US4959366 | Anti-arrhythmic agents |
Sep, 2012
(12 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Tikosyn 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 Tikosyn's family patents as well as insights into ongoing legal events on those patents.
Tikosyn's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Tikosyn's generic launch date based on the expiry of its last outstanding patent is estimated to be Oct 09, 2018 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Tikosyn Generic API suppliers:
Dofetilide is the generic name for the brand Tikosyn. 13 different companies have already filed for the generic of Tikosyn, with Accord Hlthcare having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Tikosyn's generic
How can I launch a generic of Tikosyn before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Tikosyn's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Tikosyn'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 Tikosyn -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.125 mg, 0.25 mg, and 0.5 mg | 01 May, 2014 | 1 | 06 Jun, 2016 | 09 Oct, 2018 | Eligible |
About Tikosyn
Tikosyn is a drug owned by Pfizer Pharmaceuticals Production Corp Ltd. It is used for treating cardiac arrhythmia. Tikosyn uses Dofetilide as an active ingredient. Tikosyn was launched by Pfizer in 1999.
Approval Date:
Tikosyn was approved by FDA for market use on 01 October, 1999.
Active Ingredient:
Tikosyn uses Dofetilide as the active ingredient. Check out other Drugs and Companies using Dofetilide ingredient
Treatment:
Tikosyn is used for treating cardiac arrhythmia.
Dosage:
Tikosyn is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.125MG | CAPSULE | Prescription | ORAL |
| 0.25MG | CAPSULE | Prescription | ORAL |
| 0.5MG | CAPSULE | Prescription | ORAL |