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 sixty-three patent family members in twenty-eight countries.
One supplier is listed for this compound.
Summary for tafamidis
| International Patents: | 63 |
| US Patents: | 5 |
| Tradenames: | 2 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 67 |
| 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 |
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 | Y | Y | ⤷ 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 | ||||
| >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 |
|---|---|---|---|
| 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 |
| Denmark | 1587821 | ⤷ Try a Trial | |
| Denmark | 1988397 | ⤷ Try a Trial | |
| Japan | 2010270134 | COMPOSITION AND METHOD FOR STABILIZING TRANSTHYRETIN AND INHIBITING MISFOLDING OF TRANSTHYRETIN | ⤷ 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 | 382 | Finland | ⤷ Try a Trial | |
| 1587821 | CA 2012 00006 | Denmark | ⤷ Try a Trial | |
| 1587821 | 6/2012 | Austria | ⤷ Try a Trial | PRODUCT NAME: TAFAMIDIS; REGISTRATION NO/DATE: EU/1/11/717/001 20111116 |
| 1587821 | 126 5003-2012 | Slovakia | ⤷ Try a Trial | PRODUCT NAME: TAFAMIDIS MEGLUMIN; REGISTRATION NO/DATE: EU/1/11/717/001 20111116 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
