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Last Updated: November 4, 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. Sixteen suppliers are listed for this compound.

Summary for ISONIAZID
Drug Prices for ISONIAZID

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Recent Clinical Trials for ISONIAZID

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

SponsorPhase
Freundeskreis Für Internationale Tuberkulosehilfe e.VPhase 3
Christian Medical College, Vellore, IndiaPhase 3
Indian Council of Medical ResearchPhase 3

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
Phoenix Labs Ny ISONIAZID isoniazid TABLET;ORAL 080368-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sanofi Aventis Us RIFATER isoniazid; pyrazinamide; rifampin TABLET;ORAL 050705-001 May 31, 1994 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Watson Labs ISONIAZID isoniazid TABLET;ORAL 080521-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Ivax Sub Teva Pharms ISONIAZID isoniazid TABLET;ORAL 083610-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sun Pharm Industries ISONIAZID isoniazid TABLET;ORAL 083633-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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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