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Last Updated: March 19, 2024

ISONIAZID - Generic Drug Details


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What are the generic drug sources for isoniazid and what is the scope of patent protection?

Isoniazid is the generic ingredient in eleven branded drugs marketed by Sandoz, Roche, Chartwell Rx, Cmp Pharma Inc, Lannett, Dow Pharm, Medpointe Pharm Hlc, Novartis, Barr, Duramed Pharms Barr, Epic Pharma Llc, Halsey, Hikma Intl Pharms, Impax Labs, Ivax Sub Teva Pharms, Lilly, Mk Labs, Nexgen Pharma Inc, Omnivium Pharms, Panray, Perrigo, Pharmavite, Phoenix Labs Ny, Purepac Pharm, Sun Pharm Industries, Thepharmanetwork Llc, Watson Labs, Whiteworth Town Plsn, Chartwell Molecular, Bristol Myers Squibb, Everylife, and Sanofi Aventis Us, and is included in forty-seven NDAs. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for isoniazid. Fourteen suppliers are listed for this compound.

Drug Prices for ISONIAZID

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Recent Clinical Trials for ISONIAZID

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Radboud University Medical CenterPhase 2
University College, LondonPhase 2
Haitian Group for the Study of Kaposi's Sarcoma and OpportunisticPhase 2

See all ISONIAZID clinical trials

Pharmacology for ISONIAZID
Drug ClassAntimycobacterial
Medical Subject Heading (MeSH) Categories for ISONIAZID

US Patents and Regulatory Information for ISONIAZID

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharm Industries ISONIAZID isoniazid TABLET;ORAL 080136-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Nexgen Pharma Inc ISONIAZID isoniazid TABLET;ORAL 084050-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Watson Labs ISONIAZID isoniazid TABLET;ORAL 080521-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Medpointe Pharm Hlc HYZYD isoniazid TABLET;ORAL 080134-003 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Dow Pharm DOW-ISONIAZID isoniazid TABLET;ORAL 080330-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hikma Intl Pharms ISONIAZID isoniazid TABLET;ORAL 087425-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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