Tafamidis - Generic Drug Details
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What are the generic drug sources for tafamidis and what is the scope of freedom to operate?
Tafamidis
is the generic ingredient in two branded drugs marketed by Foldrx Pharms and is included in two NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.Tafamidis has sixty-six patent family members in twenty-seven countries.
One supplier is listed for this compound.
Summary for tafamidis
| International Patents: | 66 |
| US Patents: | 3 |
| Tradenames: | 2 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 70 |
| Clinical Trials: | 29 |
| Patent Applications: | 65 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for tafamidis |
| DailyMed Link: | tafamidis at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for tafamidis
Generic Entry Date for tafamidis*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for tafamidis
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Texas Southwestern Medical Center | Phase 4 |
| Yale University | Phase 1 |
| Columbia University | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for tafamidis
US Patents and Regulatory Information for tafamidis
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Foldrx Pharms | VYNDAQEL | tafamidis meglumine | CAPSULE;ORAL | 211996-001 | May 3, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Foldrx Pharms | VYNDAMAX | tafamidis | CAPSULE;ORAL | 212161-001 | May 3, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Foldrx Pharms | VYNDAMAX | tafamidis | CAPSULE;ORAL | 212161-001 | May 3, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Foldrx Pharms | VYNDAQEL | tafamidis meglumine | CAPSULE;ORAL | 211996-001 | May 3, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Foldrx Pharms | VYNDAMAX | tafamidis | CAPSULE;ORAL | 212161-001 | May 3, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Foldrx Pharms | VYNDAMAX | tafamidis | CAPSULE;ORAL | 212161-001 | May 3, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ 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 |
EU/EMA Drug Approvals for tafamidis
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Pfizer Europe MA EEIG | Vyndaqel | tafamidis | EMEA/H/C/002294 Vyndaqel is indicated for the treatment of transthyretin amyloidosis in adult patients with stage-1 symptomatic polyneuropathy to delay peripheral neurologic impairment. |
Authorised | no | no | yes | 2011-11-16 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for tafamidis
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Canada | 2510455 | COMPOSITIONS AND METHODS FOR STABILIZING TRANSTHYRETIN AND INHIBITING TRANSTHYRETIN MISFOLDING | ⤷ Try a Trial |
| Slovenia | 1587821 | ⤷ Try a Trial | |
| Poland | 3191461 | ⤷ Try a Trial | |
| Brazil | 112017003421 | formas sólidas cristalinas de 6-carbóxi-2-(3,5-diclorofenil)-benzoxazol | ⤷ Try a Trial |
| Japan | 2020055832 | ６−カルボキシ−２−（３，５−ジクロロフェニル）−ベンゾオキサゾールの結晶性固体形態 (CRYSTALLINE SOLID FORMS OF 6-CARBOXY-2-(3,5-DICHLOROPHENYL)-BENZOXAZOLE) | ⤷ Try a Trial |
| Portugal | 1988397 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for tafamidis
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1587821 | C 2012 004 | Romania | ⤷ Try a Trial | PRODUCT NAME: TAFAMIDISMEGLUMINA; NATIONAL AUTHORISATION NUMBER: EU/1/11/717/001; DATE OF NATIONAL AUTHORISATION: 20111116; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/11/717/001; DATE OF FIRST AUTHORISATION IN EEA: 20111116 |
| 1587821 | 6/2012 | Austria | ⤷ Try a Trial | PRODUCT NAME: TAFAMIDIS; REGISTRATION NO/DATE: EU/1/11/717/001 20111116 |
| 1587821 | 12C0008 | France | ⤷ Try a Trial | PRODUCT NAME: TAFAMIDIS OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/11/717/001 20111118 |
| 1587821 | 1290005-6 | Sweden | ⤷ Try a Trial | PERIOD OF VALIDITY AFTER CORRECTION (FROM - UNTIL): 20231220 - 20261117 |
| 1587821 | CA 2012 00006 | Denmark | ⤷ Try a Trial | |
| 1587821 | SPC/GB12/009 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: TAFAMIDIS, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING THE MEGLUMINE SALT; REGISTERED: UK EU/1/11/717/001 20111118 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
