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PREVYMIS

NDA

LETERMOVIR | N219104 | MERCK SHARP AND DOHME LLC

2 strengths1 unique patent4 unique exclusivities

Patent Timeline

1 unique patent, 4 exclusivities by expiration date

Active (1)TodayExclusivity

2027

2028

2029

2030

2031

Today

RE46791

Jan. 18, 2029

Aug. 30, 2027

ODE*

Jun. 5, 2030

ODE-495

Aug. 30, 2031

ODE-497

Aug. 30, 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 Chain8 active DMFs

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

LUPIN MANUFACTURING SOLUTIONS LTDLETERMOVIR

DMF 359812021

ZYDUS LIFESCIENCES LTDLETERMOVIR

DMF 360242021

ZHEJIANG CHARIOTEER PHARMACEUTICAL CO LTDLETERMOVIR

DMF 398522024

SHANGHAI DESANO CHEMICAL PHARMACEUTICAL CO LTDLETERMOVIR

DMF 407872024

NANTONG JINGHUA PHARMACEUTICAL CO LTDLETERMOVIR

DMF 412292025

HONOUR LAB LTDLETERMOVIR (AMORPHOUS)

DMF 414412025

ZHEJIANG HISUN PHARMACEUTICAL CO LTDLETERMOVIR

DMF 423092025

BIOPHORE INDIA PHARMACEUTICALS PVT LTDLETERMOVIR

DMF 433022025

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Feb 6, 2025	SUPPL -1	View Letter (PDF)
Sep 3, 2024	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 20MG/PACKET

RLD

1 patent4 exclusivities▴

PELLETS;ORAL | Approved: Aug 30, 2024

Patents (1)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
RE46791	Jan 18, 2029	—	Yes	Yes	—	—

Exclusivities (4)

Code	Date	Status
NP	Aug 30, 2027	Active
ODE-495	Aug 30, 2031	Active
ODE-497	Aug 30, 2031	Active
ODE*	Jun 5, 2030	Active

#002 — 120MG/PACKET

RLD

1 patent4 exclusivities▾

PELLETS;ORAL | Approved: Aug 30, 2024