Question 1

Is there a generic for Tafamidis?

Accepted Answer

The FDA Orange Book does not currently list an approved generic (ANDA) for Tafamidis. It is available as 1 brand (NDA) application.

Question 2

What is the reference-listed drug for Tafamidis?

Accepted Answer

VYNDAMAX (NDA 212161, FOLDRX PHARMS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Tafamidis?

Accepted Answer

The Orange Book lists 3 patents against Tafamidis products, with the earliest listed expiry in 2026. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Question 4

Does Tafamidis have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 1 marketing-exclusivity period for Tafamidis. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

Question 5

What dosage forms of Tafamidis are approved?

Accepted Answer

Tafamidis is approved in the following dosage form: capsule.

Patent	Expires	In	Type
7214696	Dec 19, 2026	in 6 mo	U-2524
7214695	Dec 19, 2026	in 6 mo	SubstanceProduct
9770441	Aug 31, 2035	in 9 yr 4 mo	SubstanceProductU-2524

Tafamidis

Brand (NDA) products · capsule

Marketing exclusivity (1)

Listed patents (3)

Tafamidis — frequently asked questions

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