Viewing data from:

REZDIFFRA

NDA

RESMETIROM | N217785 | MADRIGAL PHARMACEUTICALS INC

3 strengths6 unique patents1 unique exclusivity

Patent Timeline

6 unique patents, 1 exclusivity by expiration date

Expiring < 1yr (1)Active (5)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

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2038

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2046

Today

Sep. 12, 2026

Sep. 17, 2033

Sep. 17, 2033

Sep. 17, 2033

Sep. 17, 2033

Feb. 4, 2045

NCE

Mar. 14, 2029

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

1 trial from ClinicalTrials.gov — 1 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
Nutrition Intervention Combined With Resmetirom for MASH NCT07680478	Phase 4	Not Yet Recruiting	City University of New York	120	2026-10-01 → 2028-06-30

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain13 active DMFs

10 active API suppliers hold Drug Master Files for this ingredient.

LEE PHARMA LTDRESMETIROM

DMF 399902024

SICHUAN ELIXIR PHARMACEUTICAL CO LTDRESMETIROM

DMF 408722024

CIPLA LTDResmetirom

DMF 409722025

SHANDONG CHEMINSPIRE PHARMACEUTICAL CO LTDRESMETIROM INTERMEDIATE: 6-(4-AMINO-2,6-DICHLOROPHENOXY)-4-ISOPROPYLPYRIDAZIN-3(2H)-ONE

DMF 410452025

SAI SREYAS PHARMACEUTICAL PRIVATE LIMITEDRESMETIROM INTERMEDIATE- N-CYANOACETYL URETHANE (NCA) (CAS 6629-04-5)”.

DMF 418812025

LEE PHARMA LTDRESMETIROM (LP FORM)

DMF 418972025

METROCHEM API PRIVATE LTDRESMETIROM

DMF 421722025

SAI SREYAS PHARMACEUTICAL PRIVATE LIMITEDRESMETIROM INTERMEDIATE – 3,6-DICHLORO-4-ISOPROPYLPYRIDAZINE (DIP IH) (CAS NO. 107228-51-3)

DMF 426042025

APICHEM LABORATORIES PRIVATE LTDRESMETIROM

DMF 426282025

BIOPHORE INDIA PHARMACEUTICALS PVT LTDRESMETIROM

DMF 427132025

ZHEJIANG HISUN PHARMACEUTICAL CO LTDRESMETIROM

DMF 432872025

CHANGZHOU PHARMACEUTICAL FACTORYRESMETIROM

DMF 432962025

APICHEM LABORATORIES PRIVATE LTDRESMETIROM [ROUTE CODE ART]

DMF 434312025

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Dec 23, 2025	SUPPL -2	View Letter (PDF)
Dec 23, 2025	SUPPL -4	View Letter (PDF)
Dec 23, 2025	SUPPL -5	View Letter (PDF)
May 17, 2024	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 60MG

RLD

6 patents1 exclusivity▴

TABLET;ORAL | Approved: Mar 14, 2024

Patents (6)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7452882	Sep 12, 2026	—	Yes	Yes	—	—
9266861	Sep 17, 2033	—	Yes	Yes	—	—
10376517	Sep 17, 2033	—	—	—		—
11564926	Sep 17, 2033	—	Yes	Yes		—
11986481	Sep 17, 2033	—	—	—		—
12377104	Feb 4, 2045	—	—	—		—

Exclusivities (1)

Code	Date	Status
NCE	Mar 14, 2029	Active

#002 — 80MG

RLD

6 patents1 exclusivity▾

TABLET;ORAL | Approved: Mar 14, 2024

#003 — 100MG

RLD

6 patents1 exclusivity▾

TABLET;ORAL | Approved: Mar 14, 2024