Viewing data from:

MYAMBUTOL

NDA

ETHAMBUTOL HYDROCHLORIDE | N016320 | KANCHAN HEALTHCARE INC

4 strengths0 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 Myambutol (2023)

Total Spending

$10K

Total Claims

210

Beneficiaries

107

Avg Cost/Unit

$0.83

Spending Trend

$18K(2019)→$68K(2020)→$10K(2021)→$7K(2022)→$10K(2023)

YoY Change:+4.5%

5yr CAGR:+1.2%

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

API Supply Chain2 active DMFs2 inactive

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

CADILA PHARMACEUTICALS LTDETHAMBUTOL HYDROCHLORIDE USP

DMF 111711994

LUPIN LTDETHAMBUTOL HYDROCHLORIDE USP

DMF 204042007

CHINOIN PHARMACEUTCIAL AND CHEMICAL WORKS CO LTDInactiveETHAMBUTOL HYDROCHLORIDE

DMF 63821986

CADILA PHARMACEUTICALS LTDInactiveETHAMBUTOL HYDROCHLORIDE USP SPECIAL

DMF 164662003

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

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Nov 3, 2008	SUPPL -63	View Letter (PDF)
Mar 28, 2004	SUPPL -60	View Letter (PDF)
Feb 6, 2003	SUPPL -58	View Letter (PDF)
Feb 6, 2003	SUPPL -57	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 100MG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 200MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

#003 — 400MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

#004 — 500MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982