DOFETILIDE Drug Patent Profile
✉ Email this page to a colleague
Which patents cover Dofetilide, and when can generic versions of Dofetilide launch?
Dofetilide is a drug marketed by Accord Hlthcare, Bionpharma, Dr Reddys Labs Sa, Granules, MSN, Novast Labs, Prinston Inc, Rk Pharma, Sigmapharm Labs Llc, Strides Pharma, Sun Pharm, and Teva Pharms Usa. and is included in twelve NDAs.
The generic ingredient in DOFETILIDE 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 Dofetilide
A generic version of DOFETILIDE was approved as dofetilide by DR REDDYS LABS SA on June 6th, 2016.
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for DOFETILIDE?
- What are the global sales for DOFETILIDE?
- What is Average Wholesale Price for DOFETILIDE?
Summary for DOFETILIDE
| US Patents: | 0 |
| Applicants: | 12 |
| NDAs: | 12 |
| Finished Product Suppliers / Packagers: | 16 |
| Raw Ingredient (Bulk) Api Vendors: | 107 |
| Clinical Trials: | 12 |
| Drug Prices: | Drug price information for DOFETILIDE |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for DOFETILIDE |
| What excipients (inactive ingredients) are in DOFETILIDE? | DOFETILIDE excipients list |
| DailyMed Link: | DOFETILIDE at DailyMed |
Recent Clinical Trials for DOFETILIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Thryv Therapeutics, Inc. | Phase 1/Phase 2 |
| Sanofi | Phase 4 |
| Duke Clinical Research Institute | Phase 4 |
Pharmacology for DOFETILIDE
| Drug Class | Antiarrhythmic |
Anatomical Therapeutic Chemical (ATC) Classes for DOFETILIDE
Paragraph IV (Patent) Challenges for DOFETILIDE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| TIKOSYN | Capsules | dofetilide | 0.125 mg, 0.25 mg, and 0.5 mg | 020931 | 1 | 2014-05-01 |
US Patents and Regulatory Information for DOFETILIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sun Pharm | DOFETILIDE | dofetilide | CAPSULE;ORAL | 210466-002 | Oct 9, 2018 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Strides Pharma | DOFETILIDE | dofetilide | CAPSULE;ORAL | 208519-001 | Oct 9, 2018 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sun Pharm | DOFETILIDE | dofetilide | CAPSULE;ORAL | 210466-003 | Oct 9, 2018 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Strides Pharma | DOFETILIDE | dofetilide | CAPSULE;ORAL | 208519-002 | Oct 9, 2018 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Accord Hlthcare | DOFETILIDE | dofetilide | CAPSULE;ORAL | 213338-001 | Jun 19, 2020 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Novast Labs | DOFETILIDE | dofetilide | CAPSULE;ORAL | 212410-003 | Dec 27, 2019 | DISCN | 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 DOFETILIDE
| 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 |
