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NDA

SETMELANOTIDE ACETATE | N213793 | RHYTHM PHARMACEUTICALS INC

1 strength3 unique patents6 unique exclusivities

Patent Timeline

3 unique patents, 6 exclusivities by expiration date

Active (3)TodayExclusivity

2027

2028

2029

2030

2031

2032

2033

2034

Today

8039435

Aug. 21, 2032

9458195

Oct. 13, 2027

11129869

Jul. 4, 2034

ODE-336

Nov. 25, 2027

NPP

Dec. 20, 2027

I-987

Mar. 19, 2029

ODE-402

Jun. 16, 2029

ODE-508

Dec. 20, 2031

ODE-509

Dec. 20, 2031

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

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain1 active DMF

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTDSETMELANOTIDE ACETATE

DMF 414902025

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

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Mar 23, 2026	SUPPL -9	View Letter (PDF)
Aug 25, 2025	SUPPL -8	View Letter (PDF)
Jan 15, 2025	SUPPL -7	View Letter (PDF)
Nov 16, 2023	SUPPL -5	View Letter (PDF)
Jun 17, 2022	SUPPL -1	View Letter (PDF)
Dec 7, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 10MG BASE/ML (EQ 10MG BASE/ML)

RLD

3 patents6 exclusivities▴

SOLUTION;SUBCUTANEOUS | Approved: Nov 25, 2020

Patents (3)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8039435	Aug 21, 2032	—	Yes	Yes	—	—
9458195	Oct 13, 2027	—	Yes	Yes	—	—
11129869	Jul 4, 2034	—	—	Yes	—	—

Exclusivities (6)

Code	Date	Status
I-987	Mar 19, 2029	Active
NPP	Dec 20, 2027	Active
ODE-336	Nov 25, 2027	Active
ODE-402	Jun 16, 2029	Active
ODE-508	Dec 20, 2031	Active
ODE-509	Dec 20, 2031	Active