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PREVYMIS

NDA

LETERMOVIR | N209940 | MERCK SHARP AND DOHME CORP

2 strengths2 unique patents6 unique exclusivities

Patent Timeline

2 unique patents, 6 exclusivities by expiration date

Active (2)TodayExclusivity

2027

2028

2029

2030

2031

2032

2033

Today

RE46791

Jan. 18, 2029

10603384

Feb. 28, 2033

I-916

Jun. 5, 2026

D-189

Aug. 2, 2026

NPP

Aug. 30, 2027

ODE-423

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

1 case on OB patents (1 active) from PACER

Case	Court	Filed	Status	Judge
MERCK SHARP & DOHME LLC et al v. ALEMBIC PHARMACEUTICALS LIMITED et al 1:2026cv08057 1 patentANDA 221473letermovir	D.N.J.	2026-07-01	Active	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

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

10 letters from Drugs@FDA

Date	Submission	Document
Feb 6, 2025	SUPPL -15	View Letter (PDF)
Sep 3, 2024	SUPPL -16	View Letter (PDF)
Sep 3, 2024	SUPPL -12	View Letter (PDF)
Aug 3, 2023	SUPPL -10	View Letter (PDF)
Jun 6, 2023	SUPPL -11	View Letter (PDF)
Mar 24, 2020	SUPPL -6	View Letter (PDF)
Dec 26, 2019	SUPPL -4	View Letter (PDF)
Sep 3, 2019	SUPPL -3	View Letter (PDF)
Mar 7, 2019	SUPPL -1	View Letter (PDF)
Nov 8, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 240MG/12ML (20MG/ML)

RLD

2 patents6 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Nov 8, 2017

Patents (2)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
RE46791	Jan 18, 2029	—	Yes	Yes	—	—
10603384	Feb 28, 2033	—	—	Yes	—	—

Exclusivities (6)

Code	Date	Status
D-189	Aug 2, 2026	< 1 year
I-916	Jun 5, 2026	Expired
NPP	Aug 30, 2027	Active
ODE-423	Jun 5, 2030	Active
ODE-495	Aug 30, 2031	Active
ODE-497	Aug 30, 2031	Active

#002 — 480MG/24ML (20MG/ML)

RLD

2 patents6 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Nov 8, 2017