Viewing data from:

PIFELTRO

NDA

DORAVIRINE | N210806 | MERCK SHARP AND DOHME CORP A SUB OF MERCK AND CO INC

1 strength1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Active (1)Today

2027

2028

2029

2030

2031

2032

Today

8486975

Aug. 30, 2032

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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

23 trials from ClinicalTrials.gov — 1 recruiting, 21 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Doravirine (DOR) in Human Immunodeficiency Virus (HIV)-Infected Children Aged 4 Weeks to <12 Years and <45 kg (MK-1439-066)NCT04375800	Phase 2	Recruiting	Merck Sharp & Dohme LLC	84	2021-02-03 → 2034-04-11
Doravirine/Islatravir (DOR/ISL) in Heavily Treatment-Experienced (HTE) Participants for Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-019)NCT04233216	Phase 3	Completed	Merck Sharp & Dohme LLC	35	2020-03-18 → 2023-11-01
Doravirine, Rifapentine and Isoniazid Interaction NCT03886701	Phase 1	Completed	Walter K. Kraft	11	2019-04-22 → 2019-05-20
Study of Doravirine/Islatravir (DOR/ISL 100 mg/0.75 mg) to Evaluate the Antiretroviral Activity, Safety, and Tolerability in Treatment-Naïve Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-020)NCT04233879	Phase 3	Completed	Merck Sharp & Dohme LLC	599	2020-02-28 → 2025-01-29
Doravirine Concentrations and Antiviral Activity in Genital Fluids in HIV-1 Infected Individuals NCT04097925	Phase 2	Completed	Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia	30	2020-02-18 → 2020-08-24
Effects of Doravirine (MK-1439) on Methadone Pharmacokinetics in Methadone-Maintained Participants (MK-1439-045)NCT02715700	Phase 1	Completed	Merck Sharp & Dohme LLC	14	2015-09-28 → 2016-08-15
A Study of Doravirine (MK-1439) in Human Immunodeficiency Virus Type 1 (HIV-1)-Infected Participants (MK-1439-005)NCT01466985	Phase 1	Completed	Merck Sharp & Dohme LLC	18	2011-10-21 → 2012-04-10
A Dose-Ranging Study to Compare Doravirine (MK-1439) Plus TRUVADA® Versus Efavirenz Plus TRUVADA® in Human Immunodeficiency Virus (HIV)-1 Infected Participants (MK-1439-007)NCT01632345	Phase 2	Completed	Merck Sharp & Dohme LLC	342	2012-10-12 → 2016-03-21
Comparison of Doravirine, Tenofovir, Lamivudine (MK-1439A) and ATRIPLA™ in Treatment-Naive Human Immunodeficiency Virus Type 1 (HIV-1)-Infected Participants (MK-1439A-021)NCT02403674	Phase 3	Completed	Merck Sharp & Dohme LLC	734	2015-06-05 → 2023-09-07
Bioavailability of Doravirine (MK-1439) Experimental Nano Formulations in Healthy Adults (MK-1439-046)NCT02549040	Phase 1	Completed	Merck Sharp & Dohme LLC	16	2015-09-21 → 2015-12-24

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

$60.76

per ea

Lowest NADAC/Unit

$60.76

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00006306901PIFELTRO 100 MG TABLET	$60.76	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

$1282.48

Highest Price

$1812.11

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00006-3069-01DORAVIRINE 100MG TAB	$1812.11	FSS	Merck Sharp & Dohme LLC	05/31/2030
00006-3069-01DORAVIRINE 100MG TAB	$1282.48	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 Pifeltro (2024)

Total Spending

$78.7M

Total Claims

42,316

Beneficiaries

4,774

Avg Cost/Unit

$58.16

Spending Trend

$14.0M(2019)→$32.8M(2020)→$47.8M(2021)→$59.5M(2022)→$70.6M(2023)→$78.7M(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.

API Supply Chain2 active DMFs

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

HETERO LABS LTDDORAVIRINE PREMIX

DMF 372162022

MATRIX PHARMACORP PRIVATE LTDDORAVIRINE

DMF 387952023

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

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Nov 8, 2024	SUPPL -11	View Letter (PDF)
Feb 1, 2022	SUPPL -7	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

RLD

1 patent0 exclusivities▴

TABLET;ORAL | Approved: Aug 30, 2018

Patents (1) · 3 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8486975	Aug 30, 2032	—	Yes	Yes		—