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ISONIAZID

NDA

ISONIAZID | N008678 | EPIC PHARMA LLC

2 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

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Lachman Consultant Services, Inc. FDA-2008-P-0251 · 4 docket documents Lachman Consultant Services, Inc. filed this petition on behalf of a client requesting that the FDA declare Isoniazid Tablets for Oral Suspension in 100 mg and 300 mg strengths suitable for consideration in an abbreviated new drug application under Section 505(j)(2)(C) of the Federal Food, Drug and	Other	2008-05-15	Open	Lachman Consultant Services, Inc.

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

118 trials from ClinicalTrials.gov — 2 recruiting, 2 active, 83 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
Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients NCT03568383	Phase 3	Active	National Institute of Allergy and Infectious Diseases (NIAID)	5,832	2019-06-03 → 2027-01-11
Novel Triple-dose Tuberculosis Retreatment Regimen NCT04260477	Phase 3	Recruiting	Institute of Tropical Medicine, Belgium	370	2021-03-01 → 2025-09
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
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
Efficacy of Weekly Rifapentine and Isoniazid for Tuberculosis Prevention NCT02430259	Phase 3	Completed	Huashan Hospital	566	2015-03 → 2018-06
Fermented Soybean Supplementation Among Active Pulmonary Tuberculosis Patients With Standard Therapy in Indonesia NCT02554318	N/A	Completed	University of Giessen	147	2013-11 → 2015-02
Prophylaxis Against Tuberculosis (TB) in Patients With Human Immunodeficiency Virus (HIV) Infection and Confirmed Latent Tuberculous Infection NCT00000636	N/A	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	2,000	— → 1997-10
Treatment of Latent Tuberculosis Infection With Isoniazid NCT00293228	Phase 4	Completed	Instituto Nacional de Salud Publica, Mexico	200	2007-02 → 2009-06
Early Antiretroviral Treatment and/or Early Isoniazid Prophylaxis Against Tuberculosis in HIV-infected Adults (ANRS 12136 TEMPRANO)NCT00495651	Phase 3	Completed	French National Agency for Research on AIDS and Viral Hepatitis	2,073	2008-03 → 2015-01

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

API Supply Chain4 active DMFs2 inactive

4 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

CHONGQING HUAPONT SHENGCHEM PHARMACEUTICAL CO LTDISONIAZID

DMF 432422026

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.

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Feb 6, 2025	SUPPL -30	View Letter (PDF)
Jul 14, 2016	SUPPL -28	View Letter (PDF)
May 1, 2007	SUPPL -25	View Letter (PDF)
May 1, 2007	SUPPL -26	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#002 — 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.

#003 — 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

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