DOFETILIDE - Generic Drug Details
✉ Email this page to a colleague
What are the generic sources for dofetilide and what is the scope of freedom to operate?
Dofetilide
is the generic ingredient in three branded drugs marketed by Aurobindo Pharma Ltd, Accord Hlthcare, Bionpharma, Dr Reddys Labs Sa, Granules, MSN, Novast Labs, Prinston Inc, Rk Pharma, Sigmapharm Labs Llc, Strides Pharma, Sun Pharm, Teva Pharms Usa, and Pfizer, and is included in fourteen NDAs. Additional information is available in the individual branded drug profile pages.There are thirteen drug master file entries for dofetilide. Sixteen suppliers are listed for this compound.
Summary for DOFETILIDE
US Patents: | 0 |
Tradenames: | 3 |
Applicants: | 14 |
NDAs: | 14 |
Drug Master File Entries: | 13 |
Finished Product Suppliers / Packagers: | 16 |
Raw Ingredient (Bulk) Api Vendors: | 107 |
Clinical Trials: | 12 |
Drug Prices: | Drug price trends 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 |
American Heart Association | Phase 4 |
Sanofi | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Granules | DOFETILIDE | dofetilide | CAPSULE;ORAL | 212750-003 | Oct 14, 2021 | AB | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
Granules | DOFETILIDE | dofetilide | CAPSULE;ORAL | 212750-002 | Oct 14, 2021 | AB | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
Accord Hlthcare | DOFETILIDE | dofetilide | CAPSULE;ORAL | 213338-001 | Jun 19, 2020 | AB | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
Novast Labs | DOFETILIDE | dofetilide | CAPSULE;ORAL | 212410-003 | Dec 27, 2019 | DISCN | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Granules | DOFETILIDE | dofetilide | CAPSULE;ORAL | 212750-001 | Oct 14, 2021 | AB | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
Pfizer | TIKOSYN | dofetilide | CAPSULE;ORAL | 020931-003 | Oct 1, 1999 | AB | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for DOFETILIDE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Pfizer | TIKOSYN | dofetilide | CAPSULE;ORAL | 020931-003 | Oct 1, 1999 | ⤷ Subscribe | ⤷ Subscribe |
Pfizer | TIKOSYN | dofetilide | CAPSULE;ORAL | 020931-001 | Oct 1, 1999 | ⤷ Subscribe | ⤷ Subscribe |
Pfizer | TIKOSYN | dofetilide | CAPSULE;ORAL | 020931-003 | Oct 1, 1999 | ⤷ Subscribe | ⤷ Subscribe |
Pfizer | TIKOSYN | dofetilide | CAPSULE;ORAL | 020931-002 | Oct 1, 1999 | ⤷ Subscribe | ⤷ Subscribe |
Pfizer | TIKOSYN | dofetilide | CAPSULE;ORAL | 020931-002 | Oct 1, 1999 | ⤷ Subscribe | ⤷ Subscribe |
Pfizer | TIKOSYN | dofetilide | CAPSULE;ORAL | 020931-001 | Oct 1, 1999 | ⤷ Subscribe | ⤷ Subscribe |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent 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 |
DOFETILIDE Market Analysis and Financial Projection Experimental
More… ↓
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.