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-two patent family members in twenty-eight countries.

One supplier is listed for this compound.

Summary for tafamidis

International Patents:	62
US Patents:	5
Tradenames:	2
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	58
Clinical Trials:	25
Patent Applications:	50
DailyMed Link:	tafamidis at DailyMed

Recent Clinical Trials for tafamidis

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Columbia University	Phase 4
Eidos Therapeutics, a BridgeBio company	Phase 3
Pfizer	Phase 4

See all tafamidis clinical trials

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	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	Y	Y		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

International Patents for tafamidis

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Country	Patent Number	Title	Estimated Expiration
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)	See Plans and Pricing
Brazil	112017003421	formas sólidas cristalinas de 6-carbóxi-2-(3,5-diclorofenil)-benzoxazol	See Plans and Pricing
Slovenia	1587821		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	6/2012	Austria	See Plans and Pricing	PRODUCT NAME: TAFAMIDIS; REGISTRATION NO/DATE: EU/1/11/717/001 20111116
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	382	Finland	See Plans and Pricing
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.