Question 1

Is there a generic for Resmetirom?

Accepted Answer

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

Question 2

What is the reference-listed drug for Resmetirom?

Accepted Answer

REZDIFFRA (NDA 217785, MADRIGAL) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Resmetirom?

Accepted Answer

The Orange Book lists 6 patents against Resmetirom 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 Resmetirom have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 3 marketing-exclusivity periods for Resmetirom. 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 Resmetirom are approved?

Accepted Answer

Resmetirom is approved in the following dosage form: tablet.

Patent	Expires	In	Type
7452882	Sep 12, 2026	in 3 mo	SubstanceProduct
11986481	Sep 17, 2033	in 7 yr 4 mo	U-3861
11564926	Sep 17, 2033	in 7 yr 4 mo	SubstanceProductU-3861
10376517	Sep 17, 2033	in 7 yr 4 mo	U-3861
9266861	Sep 17, 2033	in 7 yr 4 mo	SubstanceProduct
12377104	Feb 04, 2045	in 18 yr 11 mo	U-3861

Resmetirom

Brand (NDA) products · tablet

Marketing exclusivity (3)

Listed patents (6)

Resmetirom — frequently asked questions

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