PROCAINAMIDE HYDROCHLORIDE - Generic Drug Details

What are the generic drug sources for procainamide hydrochloride and what is the scope of freedom to operate?

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, Gland Pharma Ltd, Hikma, 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-one NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for procainamide hydrochloride. Seven suppliers are listed for this compound.

Summary for PROCAINAMIDE HYDROCHLORIDE

US Patents:	0
Tradenames:	7
Applicants:	26
NDAs:	71
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	119
Clinical Trials:	16
Patent Applications:	1,898
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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Apothecon	PRONESTYL	procainamide hydrochloride	TABLET;ORAL	017371-003	Approved Prior to Jan 1, 1982		DISCN	No	No
Parkedale	PROCAN SR	procainamide hydrochloride	TABLET, EXTENDED RELEASE;ORAL	086065-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Lannett	PROCAINAMIDE HYDROCHLORIDE	procainamide hydrochloride	CAPSULE;ORAL	084696-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Pharmafair	PROCAINAMIDE HYDROCHLORIDE	procainamide hydrochloride	INJECTABLE;INJECTION	088824-001	Nov 20, 1985		DISCN	No	No
Hikma	PROCAINAMIDE HYDROCHLORIDE	procainamide hydrochloride	INJECTABLE;INJECTION	089029-001	Apr 17, 1986		DISCN	No	No
Watson Labs	PROCAINAMIDE HYDROCHLORIDE	procainamide hydrochloride	TABLET, EXTENDED RELEASE;ORAL	089520-001	Jan 15, 1987		DISCN	No	No
Parkedale	PROCAN SR	procainamide hydrochloride	TABLET, EXTENDED RELEASE;ORAL	088489-001	Jan 16, 1985		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