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 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:	64
Clinical Trials:	29
Patent Applications:	50
DailyMed Link:	tafamidis at DailyMed

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

See all tafamidis clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for tafamidis

N07XX	Other nervous system drugs
N07X	OTHER NERVOUS SYSTEM DRUGS
N07	OTHER NERVOUS SYSTEM DRUGS
N	Nervous system

US Patents and Regulatory Information for tafamidis

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Glossary

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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	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Foldrx Pharms	VYNDAMAX	tafamidis	CAPSULE;ORAL	212161-001	May 3, 2019		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing	Y	Y		See Plans and Pricing
Foldrx Pharms	VYNDAMAX	tafamidis	CAPSULE;ORAL	212161-001	May 3, 2019		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Foldrx Pharms	VYNDAMAX	tafamidis	CAPSULE;ORAL	212161-001	May 3, 2019		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Foldrx Pharms	VYNDAQEL	tafamidis meglumine	CAPSULE;ORAL	211996-001	May 3, 2019		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing	Y	Y		See Plans and Pricing
Foldrx Pharms	VYNDAQEL	tafamidis meglumine	CAPSULE;ORAL	211996-001	May 3, 2019		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Foldrx Pharms	VYNDAMAX	tafamidis	CAPSULE;ORAL	212161-001	May 3, 2019		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
>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

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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

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	1587821	COMPOSITIONS AND METHODS FOR STABILIZING TRANSTHYRETIN AND INHIBITING TRANSTHYRETIN MISFOLDING	See Plans and Pricing
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)	See Plans and Pricing
China	1747965	Compositions and methods for stabilizing transthyretin and inhibiting transthyretin misfolding	See Plans and Pricing
Germany	60323155		See Plans and Pricing
South Korea	20170040314	6-카르복시-2--벤족사졸의 결정질 고체 형태 (6--2-35-- CRYSTALLINE SOLID FORMS OF 6-CARBOXY-2-35-DICHLOROPHENYL-BENZOXAZOLE)	See Plans and Pricing
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)	See Plans and Pricing
World Intellectual Property Organization (WIPO)	2016038500		See Plans and Pricing
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for tafamidis

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1587821	12C0008	France	See Plans and Pricing	PRODUCT NAME: TAFAMIDIS OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/11/717/001 20111118
1587821	C20120001 00050	Estonia	See Plans and Pricing	PRODUCT NAME: VYNDAQEL - TAFAMIDIS;REG NO/DATE: C(2011)8519 FINAL 16.11.2011
1587821	91935	Luxembourg	See Plans and Pricing	91935, EXPIRES: 20261116
1587821	1290005-6	Sweden	See Plans and Pricing	PERIOD OF VALIDITY AFTER CORRECTION (FROM - UNTIL): 20231220 - 20261117
1587821	2012/007	Ireland	See Plans and Pricing	PRODUCT NAME: VYNDAQEL- TAFAMIDIS MEGLUMINE; REGISTRATION NO/DATE: EU/1/11/717/001 20111116
1587821	126 5003-2012	Slovakia	See Plans and Pricing	PRODUCT NAME: TAFAMIDIS MEGLUMIN; REGISTRATION NO/DATE: EU/1/11/717/001 20111116
1587821	CA 2012 00006	Denmark	See Plans and Pricing
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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