TAFAMIDIS MEGLUMINE - Generic Drug Details

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What are the generic sources for tafamidis meglumine and what is the scope of freedom to operate?

Tafamidis meglumine is the generic ingredient in one branded drug marketed by Foldrx Pharms and is included in one NDA. There are two 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:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	26
Clinical Trials:	9
Patent Applications:	157
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TAFAMIDIS MEGLUMINE
What excipients (inactive ingredients) are in TAFAMIDIS MEGLUMINE?	TAFAMIDIS MEGLUMINE excipients list
DailyMed Link:	TAFAMIDIS MEGLUMINE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for TAFAMIDIS MEGLUMINE

Generic Entry Date for TAFAMIDIS MEGLUMINE^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: TREATMENT OF THE CARDIOMYOPATHY OF WILD TYPE OR HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS (ATTR-CM) IN ADULTS TO REDUCE CARDIOVASCULAR MORTALITY AND CARDIOVASCULAR-RELATED HOSPITALIZATION 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 MEGLUMINE

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

Sponsor	Phase
Pfizer	Phase 4
Pfizer	Phase 1
Pfizer	Phase 3

See all TAFAMIDIS MEGLUMINE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for TAFAMIDIS MEGLUMINE

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

Paragraph IV (Patent) Challenges for TAFAMIDIS MEGLUMINE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VYNDAQEL	Capsules	tafamidis meglumine	20 mg	211996	1	2023-05-03

US Patents and Regulatory Information for TAFAMIDIS MEGLUMINE

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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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Foldrx Pharms	VYNDAQEL	tafamidis meglumine	CAPSULE;ORAL	211996-001	May 3, 2019		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Foldrx Pharms	VYNDAQEL	tafamidis meglumine	CAPSULE;ORAL	211996-001	May 3, 2019		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for TAFAMIDIS MEGLUMINE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Foldrx Pharms	VYNDAQEL	tafamidis meglumine	CAPSULE;ORAL	211996-001	May 3, 2019	⤷ Sign Up	⤷ Sign Up
Foldrx Pharms	VYNDAQEL	tafamidis meglumine	CAPSULE;ORAL	211996-001	May 3, 2019	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for TAFAMIDIS MEGLUMINE

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Country	Patent Number	Title	Estimated Expiration
Spain	2312857		⤷ Sign Up
South Korea	20050090410	COMPOSITIONS AND METHODS FOR STABILIZING TRANSTHYRETIN AND INHIBITING TRANSTHYRETIN MISFOLDING	⤷ Sign Up
China	101413143	Compositions and methods for stabilizing transthyretin and inhibiting transthyretin misfolding	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for TAFAMIDIS MEGLUMINE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1587821	126 5003-2012	Slovakia	⤷ Sign Up	PRODUCT NAME: TAFAMIDIS MEGLUMIN; REGISTRATION NO/DATE: EU/1/11/717/001 20111116
1587821	382	Finland	⤷ Sign Up
1587821	1290005-6	Sweden	⤷ Sign Up	PERIOD OF VALIDITY AFTER CORRECTION (FROM - UNTIL): 20231220 - 20261117
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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