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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

1 trial from ClinicalTrials.gov — 1 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
Rifapentine-Based Shorter Regimens for Tuberculosis and TB Infection in Kazakhstan NCT07668479	—	Not Yet Recruiting	Public Union "Kazakhstan Association of Phthisiopulmonologists"	350	2026-07-01 → 2027-08

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

Medicare Part D Spending

CMS annual spending data for Priftin (2023)

Total Spending

$420K

Total Claims

2,228

Beneficiaries

1,302

Avg Cost/Unit

$4.86

Spending Trend

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

YoY Change:+5.3%

5yr CAGR:+5.8%

Source: CMS Medicare Part D Spending by Drug (2023). 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

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.