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Tafamidis meglumine - Generic Drug Details
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What are the generic sources for tafamidis meglumine and what is the scope of patent protection?
Tafamidis meglumine
is the generic ingredient in one branded drug marketed by Foldrx Pharms and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.Tafamidis meglumine has thirty-five patent family members in seventeen countries.
One supplier is listed for this compound.
Summary for tafamidis meglumine
| International Patents: | 35 |
| US Patents: | 4 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 13 |
| Clinical Trials: | 7 |
| Patent Applications: | 5 |
| What excipients (inactive ingredients) are in tafamidis meglumine? | tafamidis meglumine excipients list |
| DailyMed Link: | tafamidis meglumine at DailyMed |
Recent Clinical Trials for tafamidis meglumine
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Pfizer | Phase 1 |
| Pfizer | Phase 3 |
US Patents and Regulatory Information for tafamidis meglumine
| 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 | 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 | 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 meglumine
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Germany | 60323155 | Start Trial |
| Canada | 2800237 | Start Trial |
| European Patent Office | 2325651 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for tafamidis meglumine
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1587821 | C 2012 004 | Romania | Start 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 | CR 2012 00006 | Denmark | Start Trial | PRODUCT NAME: TAFAMIDIS (SOM MEGLUMIN); REG. NO/DATE: EU/1/11/717/001 20111116 |
| 1587821 | SPC/GB12/009 | United Kingdom | Start 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 |
