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, Ascot, Ivax Sub Teva Pharms, Lannett, Lederle, Roxane, Vangard, Watson Labs, Parke Davis, Panray, Apothecon, Abraxis Pharm, Hospira, Intl Medication, Nexus, 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 four drug master file entries for procainamide hydrochloride. Five suppliers are listed for this compound.

Summary for procainamide hydrochloride

US Patents:	0
Tradenames:	7
Applicants:	24
NDAs:	70
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	119
Clinical Trials:	16
Patent Applications:	1,898
Formulation / Manufacturing:	see details
What excipients (inactive ingredients) are in procainamide hydrochloride?	procainamide hydrochloride excipients list
DailyMed Link:	procainamide hydrochloride at DailyMed

Recent Clinical Trials for procainamide hydrochloride

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

Sponsor	Phase
Abant Izzet Baysal University	N/A
Jeffrey Moak	Phase 4
Ottawa Hospital Research Institute	Phase 4

See all procainamide hydrochloride clinical trials

Pharmacology for procainamide hydrochloride

Drug Class	Antiarrhythmic

Medical Subject Heading (MeSH) Categories for procainamide hydrochloride

Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers

Anatomical Therapeutic Chemical (ATC) Classes for procainamide hydrochloride

C01BA	Antiarrhythmics, class Ia
C01B	ANTIARRHYTHMICS, CLASS I AND III
C01	CARDIAC THERAPY
C	Cardiovascular system

US Patents and Regulatory Information for procainamide hydrochloride

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
West-ward Pharms Int	PROCAINAMIDE HYDROCHLORIDE	procainamide hydrochloride	INJECTABLE;INJECTION	089029-001	Apr 17, 1986		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ani Pharms	PROCAINAMIDE HYDROCHLORIDE	procainamide hydrochloride	CAPSULE;ORAL	089219-002	Jul 1, 1986		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Apothecon	PRONESTYL	procainamide hydrochloride	CAPSULE;ORAL	007335-003	Approved Prior to Jan 1, 1982		DISCN	Yes	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

Expired US Patents for procainamide hydrochloride

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

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