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PRIFTIN

NDA

RIFAPENTINE | N021024 | SANOFI AVENTIS US LLC

1 strength0 unique patents0 unique exclusivities

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

39 trials from ClinicalTrials.gov — 1 recruiting, 1 active, 28 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Tuberculosis Preventive Therapy Among Latent Tuberculosis Infection in HIV-infected Individuals NCT03785106	Phase 3	Active	The HIV Netherlands Australia Thailand Research Collaboration	2,500	2019-08-15 → 2038-03
Assessment of the Safety, Tolerability, and Effectiveness of Rifapentine Given Daily for LTBI NCT03474029	Phase 2/3	Recruiting	Centers for Disease Control and Prevention	3,400	2019-08-01 → 2029-12-31
Efficacy of Weekly Rifapentine and Isoniazid for Tuberculosis Prevention NCT02430259	Phase 3	Completed	Huashan Hospital	566	2015-03 → 2018-06
Brief Rifapentine-Isoniazid Evaluation for TB Prevention (BRIEF TB)NCT01404312	Phase 3	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	3,000	2012-05-23 → 2017-11-14
Study 33: Adherence to Latent Tuberculosis Infection Treatment 3HP SAT Versus 3HP DOT NCT01582711	Phase 3	Completed	Centers for Disease Control and Prevention	1,002	2012-09 → 2014-10
Impact of Weekly Administration of Rifapentine and Isoniazid on Steady State Pharmacokinetics of Tenofovir Alafenamide in Healthy Volunteers (YODA)NCT03510468	Phase 1	Completed	National Institutes of Health Clinical Center (CC)	51	2018-06-12 → 2022-12-21
Two-month Regimens Using Novel Combinations to Augment Treatment Effectiveness for Drug-sensitive Tuberculosis NCT03474198	Phase 2/3	Completed	University College, London	675	2018-03-21 → 2022-01-20
PK Interaction Between Rifapentine or Rifampicin and a Single Dose of TMC207 in Healthy Subjects (TMC207-CL002)NCT02216331	Phase 1	Completed	Global Alliance for TB Drug Development	32	2010-03 → 2010-05
Risk of SDRs Under 3HP and 1HP Regimen for LTBI NCT04094012	Phase 3	Completed	National Taiwan University Hospital	490	2019-09-24 → 2023-12-15
Study of Daily Rifapentine for Pulmonary Tuberculosis NCT00814671	Phase 2	Completed	Johns Hopkins University	153	2010-04 → 2014-09

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

$4.82

per ea

Lowest NADAC/Unit

$4.82

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00088210224PRIFTIN 150 MG TABLET	$4.82	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

$74.26

Highest Price

$87.04

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00088-2102-24PRIFTIN 150MG TAB	$87.04	FSS	Sanofi Aventis U.S. LLC	05/31/2028
00088-2102-24PRIFTIN 150MG TAB	$74.26	Big4	Sanofi Aventis U.S. LLC	05/31/2028

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

Medicare Part D Spending

CMS annual spending data for Priftin (2024)

Total Spending

$552K

Total Claims

2,888

Beneficiaries

1,697

Avg Cost/Unit

$4.79

Spending Trend

$275K(2019)→$227K(2020)→$297K(2021)→$281K(2022)→$420K(2023)→$552K(2024)

YoY Change:-1.4%

5yr CAGR:+4.1%

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.

MACLEODS PHARMACEUTICALS LTDRIFAPENTINE

DMF 359612021

WUXI FORTUNE PHARMACEUTICAL CO LTDRIFAPENTINE

DMF 396902024

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

Approval Letters

11 letters from Drugs@FDA

Date	Submission	Document
Jan 28, 2026	SUPPL -22	View Letter (PDF)
Jun 10, 2020	SUPPL -20	View Letter (PDF)
Jun 8, 2020	SUPPL -18	View Letter (PDF)
Jun 8, 2020	SUPPL -17	View Letter (PDF)
Jul 8, 2015	SUPPL -13	View Letter (PDF)
Nov 26, 2014	SUPPL -11	View Letter (PDF)
Nov 24, 2014	SUPPL -10	View Letter (PDF)
Aug 9, 2010	SUPPL -9	View Letter (PDF)
Jun 2, 2009	SUPPL -8	View Letter (PDF)
Oct 20, 2000	SUPPL -5	View Letter (PDF)
Jun 22, 1998	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 150MG

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jun 22, 1998

No patent or exclusivity listings for this strength.