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 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 |
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 | VYNDAMAX | tafamidis | CAPSULE;ORAL | 212161-001 | 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 | 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 | Y | Y | ⤷ 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 | ||||
>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 |
---|---|---|---|
European Patent Office | 3977993 | FORMES CRISTALLINES SOLIDES DU 6-CARBOXY-2-(3,5-DICHLOROPHÉNYL)-BENZOXAZOLE POUR L'UTILISATION COMME MÉDICAMENTS (CRYSTALLINE SOLID FORMS OF 6-CARBOXY-2-(3,5-DICHLOROPHENYL)-BENZOXAZOLE FOR USE AS A MEDICAMENT) | ⤷ Try a Trial |
Spain | 2901785 | ⤷ Try a Trial | |
South Africa | 200505034 | Compositions and methods for stabilizing transthyretin and inhibiting transthyretin misfolding | ⤷ Try a Trial |
China | 106715405 | 6‑羧基‑2‑(3,5‑二氯苯基)苯并噁唑的结晶固体形式 (Crystalline solid forms of 6-carboxy-2-(3,5-dichlorophenyl)-benzoxazole) | ⤷ Try a Trial |
Australia | 2003303196 | COMPOSITIONS AND METHODS FOR STABILIZING TRANSTHYRETIN AND INHIBITING TRANSTHYRETIN MISFOLDING | ⤷ 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 | C20120001 00050 | Estonia | ⤷ Try a Trial | PRODUCT NAME: VYNDAQEL - TAFAMIDIS;REG NO/DATE: C(2011)8519 FINAL 16.11.2011 |
1587821 | C01587821/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: TAFAMIDIS; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67083 09.03.2020 |
1587821 | C300516 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: TAFAMIDIS, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER TAFAMIDIS MEGLUMINE ZOUT; REGISTRATION NO/DATE: EU/1/11/717/001 20111116 |
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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |