RIMANTADINE HYDROCHLORIDE - Generic Drug Details

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

Rimantadine hydrochloride is the generic ingredient in two branded drugs marketed by Forest Labs, Sun Pharm Inds Inc, Chartwell Rx, Impax Labs, and Impax Labs Inc, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

There are three drug master file entries for rimantadine hydrochloride. One supplier is listed for this compound.

Summary for RIMANTADINE HYDROCHLORIDE

US Patents:	0
Tradenames:	2
Applicants:	5
NDAs:	5
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	149
Clinical Trials:	6
Patent Applications:	2,036
What excipients (inactive ingredients) are in RIMANTADINE HYDROCHLORIDE?	RIMANTADINE HYDROCHLORIDE excipients list
DailyMed Link:	RIMANTADINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for RIMANTADINE HYDROCHLORIDE

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

Sponsor	Phase
University of Oxford	Phase 2/Phase 3
The Leeds Teaching Hospitals NHS Trust
Cancer Research UK

See all RIMANTADINE HYDROCHLORIDE clinical trials

Pharmacology for RIMANTADINE HYDROCHLORIDE

Drug Class	Influenza A M2 Protein Inhibitor
Mechanism of Action	M2 Protein Inhibitors

Medical Subject Heading (MeSH) Categories for RIMANTADINE HYDROCHLORIDE

Antiviral Agents

Nucleic Acid Synthesis Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for RIMANTADINE HYDROCHLORIDE

J05AC	Cyclic amines
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for RIMANTADINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Impax Labs	RIMANTADINE HYDROCHLORIDE	rimantadine hydrochloride	TABLET;ORAL	076132-001	Aug 30, 2002		RX	No	Yes
Sun Pharm Inds Inc	FLUMADINE	rimantadine hydrochloride	TABLET;ORAL	019649-001	Sep 17, 1993		DISCN	Yes	No
Chartwell Rx	RIMANTADINE HYDROCHLORIDE	rimantadine hydrochloride	TABLET;ORAL	076375-001	Jan 14, 2003		DISCN	No	No
Forest Labs	FLUMADINE	rimantadine hydrochloride	SYRUP;ORAL	019650-001	Sep 17, 1993		DISCN	No	No
Impax Labs Inc	RIMANTADINE HYDROCHLORIDE	rimantadine hydrochloride	TABLET;ORAL	075916-001	Nov 2, 2001		DISCN	No	No