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Dofetilide - Generic Drug Details
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What are the generic drug 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, Bionpharma Inc, Mayne Pharma Inc, MSN, Par Pharm Inc, Prinston Inc, Riconpharma Llc, Sigmapharm Labs Llc, Sun Pharm, and Pfizer, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.There are thirteen drug master file entries for dofetilide. Eleven suppliers are listed for this compound.
Summary for dofetilide
| US Patents: | 0 |
| Tradenames: | 3 |
| Applicants: | 10 |
| NDAs: | 10 |
| Drug Master File Entries: | 13 |
| Suppliers / Packagers: | 11 |
| Bulk Api Vendors: | 88 |
| Clinical Trials: | 8 |
| Patent Applications: | 2,896 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for dofetilide |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for dofetilide |
| DailyMed Link: | dofetilide at DailyMed |
Recent Clinical Trials for dofetilide
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Oregon Health and Science University | Phase 2 |
| Gilead Sciences | Phase 1 |
| VA Office of Research and Development | N/A |
Pharmacology for dofetilide
| Drug Class | Antiarrhythmic |
Paragraph IV (Patent) Challenges for DOFETILIDE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| TIKOSYN | CAPSULE;ORAL | dofetilide | 020931 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Bionpharma Inc | DOFETILIDE | dofetilide | CAPSULE;ORAL | 208625-002 | Apr 10, 2018 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Pfizer | TIKOSYN | dofetilide | CAPSULE;ORAL | 020931-001 | Oct 1, 1999 | AB | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
| Par Pharm Inc | DOFETILIDE | dofetilide | CAPSULE;ORAL | 208519-001 | Oct 9, 2018 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Mayne Pharma Inc | DOFETILIDE | dofetilide | CAPSULE;ORAL | 207058-001 | Jun 6, 2016 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Sigmapharm Labs Llc | DOFETILIDE | dofetilide | CAPSULE;ORAL | 207746-002 | Mar 26, 2018 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Prinston Inc | DOFETILIDE | dofetilide | CAPSULE;ORAL | 211223-002 | Dec 17, 2019 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| >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 | Start Trial | Start Trial |
| Pfizer | TIKOSYN | dofetilide | CAPSULE;ORAL | 020931-001 | Oct 1, 1999 | Start Trial | Start Trial |
| Pfizer | TIKOSYN | dofetilide | CAPSULE;ORAL | 020931-002 | Oct 1, 1999 | Start Trial | Start Trial |
| Pfizer | TIKOSYN | dofetilide | CAPSULE;ORAL | 020931-001 | Oct 1, 1999 | Start Trial | Start Trial |
| Pfizer | TIKOSYN | dofetilide | CAPSULE;ORAL | 020931-002 | Oct 1, 1999 | Start Trial | Start Trial |
| Pfizer | TIKOSYN | dofetilide | CAPSULE;ORAL | 020931-003 | Oct 1, 1999 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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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.
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