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ISONIAZID

NDA

ISONIAZID | N008428 | PANRAY CORP SUB ORMONT DRUG AND CHEMICAL CO INC

3 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 Isoniazid (2023)

Total Spending

$365K

Total Claims

34,417

Beneficiaries

11,875

Avg Cost/Unit

$0.23

Spending Trend

$475K(2019)→$385K(2020)→$327K(2021)→$323K(2022)→$365K(2023)

YoY Change:+4.1%

5yr CAGR:+0.2%

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

API Supply Chain3 active DMFs2 inactive

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

YUKI GOSEI KOGYO CO LTDISONIAZID BULK FORM

DMF 47721982

YANGZHOU PHARMACEUTICAL CO LTDISONIAZID

DMF 162352002

CALYX CHEMICALS AND PHARMACEUTICALS LTDISONIAZID

DMF 213222008

BAYER CORPInactiveISONIAZID (NEOTEBEN)

DMF 58901985

BEIJING SECOND PHARMACEUTICAL FACTORYInactiveISONIAZID USP23

DMF 146622000

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

Products (3)

Sort:

#001 — 50MG

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.

#002 — 100MG

0 patents0 exclusivities▾

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

#003 — 300MG

0 patents0 exclusivities▾

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