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Boehringer Ingelheim
Mallinckrodt

Last Updated: January 22, 2020

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Isoniazid; rifampin - Generic Drug Details

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

Isoniazid; rifampin is the generic ingredient in two branded drugs marketed by Sanofi Aventis Us and Hikma Intl Pharms, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for isoniazid; rifampin. One supplier is listed for this compound.

Summary for isoniazid; rifampin
Recent Clinical Trials for isoniazid; rifampin

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

SponsorPhase
Fifth Affiliated Hospital, Sun Yat-Sen UniversityN/A
Andrew DinardoPhase 2
Celgene CorporationPhase 2

See all isoniazid; rifampin clinical trials

Pharmacology for isoniazid; rifampin

US Patents and Regulatory Information for isoniazid; rifampin

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sanofi Aventis Us RIFAMATE isoniazid; rifampin CAPSULE;ORAL 061884-001 Approved Prior to Jan 1, 1982 RX No Yes   Start Trial   Start Trial   Start Trial
Hikma Intl Pharms RIFAMPIN AND ISONIAZID isoniazid; rifampin CAPSULE;ORAL 065221-001 Jul 29, 2005 DISCN No 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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Serving leading biopharmaceutical companies globally:

Merck
Mallinckrodt
McKesson
Express Scripts
Dow
Baxter

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