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Tafamidis - Generic Drug Details
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What are the generic drug sources for tafamidis and what is the scope of patent protection?
Tafamidis
is the generic ingredient in two branded drugs marketed by Foldrx Pharms and is included in two NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.Tafamidis has fifty-three patent family members in twenty-three countries.
One supplier is listed for this compound.
Summary for tafamidis
| International Patents: | 53 |
| US Patents: | 5 |
| Tradenames: | 2 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 52 |
| Clinical Trials: | 20 |
| Patent Applications: | 100 |
| DailyMed Link: | tafamidis at DailyMed |
Recent Clinical Trials for tafamidis
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Boston University | Early Phase 1 |
| Corino Therapeutics, Inc. | Early Phase 1 |
| Pfizer | Phase 1 |
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 | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Foldrx Pharms | VYNDAQEL | tafamidis meglumine | CAPSULE;ORAL | 211996-001 | May 3, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Foldrx Pharms | VYNDAMAX | tafamidis | CAPSULE;ORAL | 212161-001 | May 3, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Foldrx Pharms | VYNDAQEL | tafamidis meglumine | CAPSULE;ORAL | 211996-001 | May 3, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for tafamidis
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| China | 1747965 | Start Trial |
| China | 101413143 | Start Trial |
| Japan | 2020055832 | Start Trial |
| China | 100448852 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for tafamidis
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1587821 | 382 | Finland | Start Trial | |
| 1587821 | 12C0008 | France | Start Trial | PRODUCT NAME: TAFAMIDIS OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/11/717/001 20111116 |
| 1587821 | C20120001 00050 | Estonia | Start Trial | PRODUCT NAME: VYNDAQEL - TAFAMIDIS;REG NO/DATE: C(2011)8519 FINAL 16.11.2011 |
| 1587821 | 2012/007 | Ireland | Start Trial | PRODUCT NAME: VYNDAQEL- TAFAMIDIS MEGLUMINE; REGISTRATION NO/DATE: EU/1/11/717/001 20111116 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
