Viewing data from:

IDVYNSO

NDA

DORAVIRINE; ISLATRAVIR | N216964 | MERCK SHARP AND DOHME LLC

1 strength2 unique patents1 unique exclusivity

Patent Timeline

2 unique patents, 1 exclusivity by expiration date

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

2027

2028

2029

2030

2031

2032

Today

7339053

May. 31, 2027

8486975

Aug. 30, 2032

NCE

Apr. 20, 2031

PTAB Proceedings

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

Patent Reexaminations

1 reexamination on OB patents from USPTO Patent Center

96/000,265Ex PartePending

Patent: 8486975Filed: 2018-07-02

NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS

Source: USPTO Patent Center. Ex parte and inter partes reexamination proceedings.

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
Apr 21, 2026	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 100MG;0.25MG

RLD

2 patents1 exclusivity▴

TABLET;ORAL | Approved: Apr 20, 2026

Patents (2)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7339053	May 31, 2027	—	Yes	—	—	—
8486975	Aug 30, 2032	—	Yes	Yes	U-4527	—

Exclusivities (1)

Code	Date	Status
NCE	Apr 20, 2031	Active

Change History (2)

Recent changes detected for this application.

ADDED7/1/2026

MSD added U.S. Patent 7,339,053 to the Orange Book for IDVYNSO (doravirine; islatravir).

New: New record

ADDED7/1/2026

MSD added U.S. Patent 8,486,975 to the Orange Book for IDVYNSO (doravirine; islatravir).

New: New record