IMODIUM MULTI-SYMPTOM RELIEF Drug Patent Profile

When do Imodium Multi-symptom Relief patents expire, and when can generic versions of Imodium Multi-symptom Relief launch?

Imodium Multi-symptom Relief is a drug marketed by J And J Consumer Inc and is included in two NDAs.

The generic ingredient in IMODIUM MULTI-SYMPTOM RELIEF is loperamide hydrochloride; simethicone. There are eleven drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the loperamide hydrochloride; simethicone profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Imodium Multi-symptom Relief

A generic version of IMODIUM MULTI-SYMPTOM RELIEF was approved as loperamide hydrochloride; simethicone by PERRIGO on August 30^th, 2002.

Summary for IMODIUM MULTI-SYMPTOM RELIEF

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Clinical Trials:	24
Formulation / Manufacturing:	see details
DailyMed Link:	IMODIUM MULTI-SYMPTOM RELIEF at DailyMed

Recent Clinical Trials for IMODIUM MULTI-SYMPTOM RELIEF

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

Sponsor	Phase
Naia Pharmaceuticals	Phase 1/Phase 2
9 Meters Biopharma, Inc.	Phase 1/Phase 2
McNeil AB	Phase 1

See all IMODIUM MULTI-SYMPTOM RELIEF clinical trials

Pharmacology for IMODIUM MULTI-SYMPTOM RELIEF

Drug Class	Opioid Agonist
Mechanism of Action	Opioid Agonists
Physiological Effect	Skin Barrier Activity

Anatomical Therapeutic Chemical (ATC) Classes for IMODIUM MULTI-SYMPTOM RELIEF

A07DA	Antipropulsives
A07D	ANTIPROPULSIVES
A07	ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A	Alimentary tract and metabolism

Paragraph IV (Patent) Challenges for IMODIUM MULTI-SYMPTOM RELIEF

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
IMODIUM MULTI-SYMPTOM RELIEF	Tablets	loperamide hydrochloride; simethicone	2 mg/125 mg	021140		2004-12-29

US Patents and Regulatory Information for IMODIUM MULTI-SYMPTOM RELIEF

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
J And J Consumer Inc	IMODIUM MULTI-SYMPTOM RELIEF	loperamide hydrochloride; simethicone	TABLET, CHEWABLE;ORAL	020606-001	Jun 26, 1996		DISCN	Yes	No
J And J Consumer Inc	IMODIUM MULTI-SYMPTOM RELIEF	loperamide hydrochloride; simethicone	TABLET;ORAL	021140-001	Nov 30, 2000		OTC	Yes	Yes

Expired US Patents for IMODIUM MULTI-SYMPTOM RELIEF

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
J And J Consumer Inc	IMODIUM MULTI-SYMPTOM RELIEF	loperamide hydrochloride; simethicone	TABLET, CHEWABLE;ORAL	020606-001	Jun 26, 1996
J And J Consumer Inc	IMODIUM MULTI-SYMPTOM RELIEF	loperamide hydrochloride; simethicone	TABLET;ORAL	021140-001	Nov 30, 2000
J And J Consumer Inc	IMODIUM MULTI-SYMPTOM RELIEF	loperamide hydrochloride; simethicone	TABLET, CHEWABLE;ORAL	020606-001	Jun 26, 1996
J And J Consumer Inc	IMODIUM MULTI-SYMPTOM RELIEF	loperamide hydrochloride; simethicone	TABLET, CHEWABLE;ORAL	020606-001	Jun 26, 1996

International Patents for IMODIUM MULTI-SYMPTOM RELIEF

See the table below for patents covering IMODIUM MULTI-SYMPTOM RELIEF around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	634833
Poland	189988
Czech Republic	294084	Sypká granulovaná kompoziceŹ způsob její výroby a protipěnivá orální pevná dávková forma simethikonu (Free flowing granular composition, process for its preparation and antifoam simethicone oral solid dosage form)
Brazil	1100507

Supplementary Protection Certificates for IMODIUM MULTI-SYMPTOM RELIEF

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0428296	99C0029	Belgium		PRODUCT NAME: LOPERAMIDUM HYDROCHOLORIDUM SEMITHICONUM; NATL. REGISTRATION NO/DATE: 2 IS 145 F3 19990201; FIRST REGISTRATION: GB PL 00242/0314 19970923
0428296	SPC/GB98/013	United Kingdom		PRODUCT NAME: LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE; REGISTERED: UK 00242/0314 19970923