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Last Updated: August 11, 2020

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ISONIAZID Drug Profile

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When do Isoniazid patents expire, and what generic alternatives are available?

Isoniazid is a drug marketed by Sandoz Inc, Anda Repository, Cmp Pharma Inc, Barr, Duramed Pharms Barr, Halsey, Hikma Intl Pharms, Impax Labs, Ivax Sub Teva Pharms, Lilly, Mk Labs, Nexgen Pharma Inc, Panray, Perrigo, Pharmavite, Phoenix Labs Ny, Purepac Pharm, Sandoz, Sun Pharm Industries, Thepharmanetwork Llc, Watson Labs, and Whiteworth Town Plsn. and is included in thirty-four NDAs.

The generic ingredient in ISONIAZID is isoniazid. There are five drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the isoniazid profile page.

US ANDA Litigation and Generic Entry Outlook for Isoniazid

A generic version of ISONIAZID was approved as isoniazid by THEPHARMANETWORK LLC on October 29th, 2014.

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Drug patent expirations by year for ISONIAZID
Drug Prices for ISONIAZID

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Recent Clinical Trials for ISONIAZID

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SponsorPhase
ViiV Healthcare (VH)Phase 2
Fifth Affiliated Hospital, Sun Yat-Sen UniversityN/A
University Medical Center GroningenPhase 1

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Pharmacology for ISONIAZID
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
Watson Labs ISONIAZID isoniazid TABLET;ORAL 085784-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Sun Pharm Industries ISONIAZID isoniazid TABLET;ORAL 083633-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Purepac Pharm ISONIAZID isoniazid TABLET;ORAL 080132-004 Jul 14, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Thepharmanetwork Llc ISONIAZID isoniazid TABLET;ORAL 202610-001 Oct 29, 2014 AA RX No No   Start Trial   Start Trial   Start Trial
Sandoz ISONIAZID isoniazid TABLET;ORAL 008678-002 Approved Prior to Jan 1, 1982 DISCN Yes No   Start Trial   Start Trial   Start 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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