Viewing data from:

MYCOBUTIN

NDA

RIFABUTIN | N050689 | PFIZER INC

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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Mycobutin (2023)

Total Spending

$19K

Total Claims

Beneficiaries

Avg Cost/Unit

$14.80

Spending Trend

$17K(2019)→$32K(2020)→$90K(2021)→$47K(2022)→$19K(2023)

YoY Change:-19.7%

5yr CAGR:-12.0%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain3 active DMFs1 inactive

3 active API suppliers hold Drug Master Files for this ingredient.

LUPIN LTDRIFABUTIN USP

DMF 199022006

OLON SPARIFABUTIN

DMF 290472015

LUOHE CHIEF PHARMACEUTICAL CO LTDRIFABUTIN (USP)

DMF 357052024

CHONGQING BIOCARE PHARMACEUTICAL CO LTDInactiveRIFABUTIN USP

DMF 227872009

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

Approval Letters

8 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#001 — 150MG

RLDAB

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Dec 23, 1992

No patent or exclusivity listings for this strength.