Viewing data from:

DELSTRIGO

NDA

DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE | N210807 | MERCK SHARP AND DOHME CORP A SUB OF MERCK AND CO INC

1 strength3 unique patents0 unique exclusivities

Patent Timeline

3 unique patents by expiration date

Active (3)Today

2027

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2037

Today

8486975

Aug. 30, 2032

10603282

Nov. 29, 2036

10842751

Nov. 29, 2036

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

96/000,265Supp. ExamSE Certificate — No SNQ Found

Patent: 8486975Filed: 2018-07-02Certificate: 2018-08-29

NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS

Recent Events

2018-08-29MSNQNSE Certificate — No Substantial New Question

2018-07-02SEREQSupplemental Examination Request Filed

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

Hatch-Waxman Litigation

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

4 trials from ClinicalTrials.gov, 4 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Islatravir (MK-8591) With Doravirine and Lamivudine in Participants Infected With Human Immunodeficiency Virus Type 1 (MK-8591-011)NCT03272347	Phase 2	Completed	Merck Sharp & Dohme LLC	123	2017-11-27 → 2022-03-09
Safety and Efficacy of a Switch to Doravirine, Tenofovir, Lamivudine (MK-1439A) in Human Immunodeficiency Virus (HIV-1)-Infected Participants Virologically Suppressed on an Anti-retroviral Regimen in Combination With Two Nucleoside Reverse Transcriptase Inhibitors (MK-1439A-024)NCT02397096	Phase 3	Completed	Merck Sharp & Dohme LLC	673	2015-06-09 → 2023-09-05
Evaluating the Pharmacokinetics, Safety, and Tolerability of Doravirine (MK-1439) and Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (MK-1439A) in HIV-1-Infected Children and Adolescents NCT03332095	Phase 1/2	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	55	2018-07-02 → 2022-05-25
Safety and Efficacy of Doravirine, Tenofovir, Lamivudine (MK-1439A) in Participants Infected With Treatment-Naïve Human Immunodeficiency Virus (HIV) -1 With Transmitted Resistance (MK-1439A-030)NCT02629822	Phase 2	Completed	Merck Sharp & Dohme LLC	10	2016-01-14 → 2020-10-28

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$92.72

per ea

Lowest NADAC/Unit

$92.72

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00006500701DELSTRIGO 100-300-300 MG TAB	$92.72	EA	Brand	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$1915.28

Highest Price

$2758.23

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00006-5007-01DORAVIRINE 100MG/LAMIVUDINE 300MG/TENOFOVIR D	$2758.23	FSS	Merck Sharp & Dohme LLC	05/31/2030
00006-5007-01DORAVIRINE 100MG/LAMIVUDINE 300MG/TENOFOVIR D	$1915.28	Big4	Merck Sharp & Dohme LLC	05/31/2030

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Delstrigo (2024)

Total Spending

$18.5M

Total Claims

6,688

Beneficiaries

796

Avg Cost/Unit

$88.39

Spending Trend

$2.2M(2019)→$5.9M(2020)→$8.1M(2021)→$12.0M(2022)→$16.1M(2023)→$18.5M(2024)

YoY Change:-1.3%

5yr CAGR:+3.9%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Oct 31, 2025	SUPPL -17	View Letter (PDF)
Jun 13, 2025	SUPPL -16	View Letter (PDF)
Nov 8, 2024	SUPPL -13	View Letter (PDF)
Feb 1, 2022	SUPPL -8	View Letter (PDF)
Oct 11, 2019	SUPPL -3	View Letter (PDF)
Sep 20, 2019	SUPPL -2	View Letter (PDF)
Aug 30, 2018	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 100MG;300MG;300MG

RLD

3 patents0 exclusivities▴

TABLET;ORAL | Approved: Aug 30, 2018

Patents (3) · 3 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8486975	Aug 30, 2032	—	Yes	Yes		—
10603282	Nov 29, 2036	—	—	Yes	—	—
10842751	Nov 29, 2036	—	—	Yes	—	—