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Last Updated: February 25, 2021

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Procainamide hydrochloride - Generic Drug Details

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

Procainamide hydrochloride is the generic ingredient in seven branded drugs marketed by Ani Pharms Inc, Ascot, Ivax Sub Teva Pharms, Lannett, Lederle, Roxane, Vangard, Watson Labs, Parke Davis, Panray, Apothecon, Abraxis Pharm, Hospira, Intl Medication, Nexus Pharms, Pharmafair, Smith And Nephew, Solopak, Warner Chilcott, West-ward Pharms Int, Inwood Labs, Sandoz, Parkedale, and King Pharms, and is included in seventy NDAs. Additional information is available in the individual branded drug profile pages.

There are nine drug master file entries for procainamide hydrochloride. Four suppliers are listed for this compound.

Recent Clinical Trials for procainamide hydrochloride

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

SponsorPhase
Ottawa Hospital Research InstitutePhase 4
Rabin Medical CenterEarly Phase 1
Rambam Health Care CampusEarly Phase 1

See all procainamide hydrochloride clinical trials

Pharmacology for procainamide hydrochloride
Drug ClassAntiarrhythmic
Medical Subject Heading (MeSH) Categories for procainamide hydrochloride

US Patents and Regulatory Information for procainamide hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Watson Labs PROCAINAMIDE HYDROCHLORIDE procainamide hydrochloride TABLET, EXTENDED RELEASE;ORAL 089027-001 Oct 22, 1985 DISCN No No   Start Trial   Start Trial   Start Trial
Lannett PROCAINAMIDE HYDROCHLORIDE procainamide hydrochloride CAPSULE;ORAL 084696-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Ivax Sub Teva Pharms PROCAINAMIDE HYDROCHLORIDE procainamide hydrochloride CAPSULE;ORAL 084595-001 Approved Prior to Jan 1, 1982 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

Expired US Patents for procainamide hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
King Pharms PROCANBID procainamide hydrochloride TABLET, EXTENDED RELEASE;ORAL 020545-002 Jan 31, 1996   Start Trial   Start Trial
King Pharms PROCANBID procainamide hydrochloride TABLET, EXTENDED RELEASE;ORAL 020545-001 Jan 31, 1996   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Medtronic
Merck
Express Scripts
Johnson and Johnson
Mallinckrodt
Colorcon

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