DOFETILDE Drug Patent Profile
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When do Dofetilde patents expire, and when can generic versions of Dofetilde launch?
Dofetilde is a drug marketed by Aurobindo Pharma Ltd and is included in one NDA.
The generic ingredient in DOFETILDE is dofetilide. There are thirteen drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the dofetilide profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Dofetilde
A generic version of DOFETILDE was approved as dofetilide by DR REDDYS LABS SA on June 6th, 2016.
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Questions you can ask:
- What is the 5 year forecast for DOFETILDE?
- What are the global sales for DOFETILDE?
- What is Average Wholesale Price for DOFETILDE?
Summary for DOFETILDE
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| DailyMed Link: | DOFETILDE at DailyMed |
Pharmacology for DOFETILDE
| Drug Class | Antiarrhythmic |
US Patents and Regulatory Information for DOFETILDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Aurobindo Pharma Ltd | DOFETILDE | dofetilide | CAPSULE;ORAL | 210740-001 | Jan 22, 2019 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Aurobindo Pharma Ltd | DOFETILDE | dofetilide | CAPSULE;ORAL | 210740-002 | Jan 22, 2019 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Aurobindo Pharma Ltd | DOFETILDE | dofetilide | CAPSULE;ORAL | 210740-003 | Jan 22, 2019 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
EU/EMA Drug Approvals for DOFETILDE
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Pfizer Limited | Tikosyn | dofetilide | EMEA/H/C/000238 Tikosyn is a Class III antiarrhythmic agent that is indicated for the following:Conversion of persistent atrial fibrillation or atrial flutter to normal sinus rhythm in patients in whom cardioversion by electrical means is not appropriate and in whom the duration of the arrhythmic episode is less than 6 months (see section 5.1).Maintenance of sinus rhythm (after conversion) in patients with persistent atrial fibrillation or atrial flutter. Because TIKOSYN can cause ventricular arrhythmias, it should be reserved for patients in whom atrial fibrillation/atrial flutter is highly symptomatic and in whom other antiarrhythmic therapy is not appropriate.Dofetilide has not been shown to be effective in patients with paroxysmal atrial arrhythmias (including paroxysmal atrial fibrillation). |
Withdrawn | no | no | no | 1999-11-29 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
