Flecainide acetate - Generic Drug Details
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What are the generic sources for flecainide acetate and what is the scope of freedom to operate?
Flecainide acetate
is the generic ingredient in two branded drugs marketed by Amneal Pharm, Ani Pharms, Aurobindo Pharma Ltd, Beximco Pharms Usa, Chartwell, Hikma, Sun Pharm Inds Ltd, Yichang Humanwell, and Alvogen, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.There are ten drug master file entries for flecainide acetate. Fourteen suppliers are listed for this compound.
Summary for flecainide acetate
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 9 |
| NDAs: | 10 |
| Drug Master File Entries: | 10 |
| Finished Product Suppliers / Packagers: | 14 |
| Raw Ingredient (Bulk) Api Vendors: | 79 |
| Clinical Trials: | 5 |
| Patent Applications: | 1,148 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for flecainide acetate |
| What excipients (inactive ingredients) are in flecainide acetate? | flecainide acetate excipients list |
| DailyMed Link: | flecainide acetate at DailyMed |
Recent Clinical Trials for flecainide acetate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| InCarda Therapeutics, Inc. | Phase 3 |
| InCarda Therapeutics Australia Pty Ltd. | Phase 2 |
| InCarda Therapeutics, Inc. | Phase 2 |
Pharmacology for flecainide acetate
| Drug Class | Antiarrhythmic |
Medical Subject Heading (MeSH) Categories for flecainide acetate
Anatomical Therapeutic Chemical (ATC) Classes for flecainide acetate
US Patents and Regulatory Information for flecainide acetate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sun Pharm Inds Ltd | FLECAINIDE ACETATE | flecainide acetate | TABLET;ORAL | 076421-001 | Mar 28, 2003 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Chartwell | FLECAINIDE ACETATE | flecainide acetate | TABLET;ORAL | 079164-003 | Jul 9, 2009 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Beximco Pharms Usa | FLECAINIDE ACETATE | flecainide acetate | TABLET;ORAL | 210683-001 | Sep 16, 2020 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Ani Pharms | FLECAINIDE ACETATE | flecainide acetate | TABLET;ORAL | 076030-001 | Oct 28, 2002 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Ani Pharms | FLECAINIDE ACETATE | flecainide acetate | TABLET;ORAL | 075882-001 | Oct 28, 2002 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Alvogen | TAMBOCOR | flecainide acetate | TABLET;ORAL | 018830-004 | Aug 23, 1988 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 flecainide acetate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Alvogen | TAMBOCOR | flecainide acetate | TABLET;ORAL | 018830-003 | Jun 3, 1988 | ⤷ Try a Trial | ⤷ Try a Trial |
| Alvogen | TAMBOCOR | flecainide acetate | TABLET;ORAL | 018830-003 | Jun 3, 1988 | ⤷ Try a Trial | ⤷ Try a Trial |
| Alvogen | TAMBOCOR | flecainide acetate | TABLET;ORAL | 018830-004 | Aug 23, 1988 | ⤷ Try a Trial | ⤷ Try a Trial |
| Alvogen | TAMBOCOR | flecainide acetate | TABLET;ORAL | 018830-001 | Oct 31, 1985 | ⤷ Try a Trial | ⤷ Try a Trial |
| Alvogen | TAMBOCOR | flecainide acetate | TABLET;ORAL | 018830-004 | Aug 23, 1988 | ⤷ Try a Trial | ⤷ Try a Trial |
| Alvogen | TAMBOCOR | flecainide acetate | TABLET;ORAL | 018830-003 | Jun 3, 1988 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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.
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