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MODEYSO

NDA

DORDAVIPRONE HYDROCHLORIDE | N219876 | CHIMERIX INC

1 strength7 unique patents2 unique exclusivities

Patent Timeline

7 unique patents, 2 exclusivities by expiration date

Active (7)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

Today

Apr. 30, 2032

Jul. 26, 2034

Apr. 30, 2032

Jan. 30, 2037

Jan. 30, 2037

Mar. 1, 2036

Jan. 30, 2037

NCE

Aug. 6, 2030

ODE-547

Aug. 6, 2032

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Aug 7, 2025	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 125MG BASE

RLD

7 patents2 exclusivities▴

CAPSULE;ORAL | Approved: Aug 6, 2025

Patents (7)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
RE46290	Apr 30, 2032	—	—	—		—
9265765	Jul 26, 2034	—	—	Yes	—	—
9629842	Apr 30, 2032	—	—	—		—
10172862	Jan 30, 2037	—	—	—		—
10369154	Jan 30, 2037	—	—	—		—
11976068	Mar 1, 2036	—	—	Yes	—	—
12102639	Jan 30, 2037	—	—	—		—

Exclusivities (2)

Code	Date	Status
NCE	Aug 6, 2030	Active
ODE-547	Aug 6, 2032	Active

Change History (1)

Recent changes detected for this application.

ADDED7/1/2026

Chimerix obtained orphan drug exclusivity for Modeyso (dordaviprone hydrochloride) for NDA 219876, granting seven years of regulatory exclusivity from approval.

New: New record