Procainamide hydrochloride - Generic Drug Details

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

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
Smith And Nephew	PROCAINAMIDE HYDROCHLORIDE	procainamide hydrochloride	INJECTABLE;INJECTION	088530-001	Mar 4, 1985		DISCN	No	No
Watson Labs	PROCAINAMIDE HYDROCHLORIDE	procainamide hydrochloride	CAPSULE;ORAL	084403-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Vangard	PROCAINAMIDE HYDROCHLORIDE	procainamide hydrochloride	CAPSULE;ORAL	087875-001	Jun 1, 1982		DISCN	No	No
Lederle	PROCAINAMIDE HYDROCHLORIDE	procainamide hydrochloride	CAPSULE;ORAL	086952-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Apothecon	PRONESTYL	procainamide hydrochloride	INJECTABLE;INJECTION	007335-005	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Hospira	PROCAINAMIDE HYDROCHLORIDE	procainamide hydrochloride	INJECTABLE;INJECTION	089537-001	Aug 25, 1987		DISCN	No	No
Watson Labs	PROCAINAMIDE HYDROCHLORIDE	procainamide hydrochloride	TABLET, EXTENDED RELEASE;ORAL	088535-001	Nov 3, 1984		DISCN	No	No

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
King Pharms	PROCANBID	procainamide hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020545-001	Jan 31, 1996