ZEGERID Drug Patent Profile

Which patents cover Zegerid, and when can generic versions of Zegerid launch?

Zegerid is a drug marketed by Salix, Santarus, and Riley Consumer. and is included in five NDAs.

The generic ingredient in ZEGERID is magnesium hydroxide; omeprazole; sodium bicarbonate. There are one hundred and forty-six drug master file entries for this compound. Additional details are available on the magnesium hydroxide; omeprazole; sodium bicarbonate profile page.

Summary for ZEGERID

US Patents:	0
Applicants:	3
NDAs:	5
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	225
Clinical Trials:	13
Patent Applications:	3,819
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for ZEGERID
What excipients (inactive ingredients) are in ZEGERID?	ZEGERID excipients list
DailyMed Link:	ZEGERID at DailyMed

See drug prices for ZEGERID

Recent Clinical Trials for ZEGERID

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

Sponsor	Phase
Syndax Pharmaceuticals	Phase 1
Population Health Research Institute	Phase 3
Norgine	Phase 3

See all ZEGERID clinical trials

Pharmacology for ZEGERID

Drug Class	Proton Pump Inhibitor
Mechanism of Action	Alkalinizing Activity Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors

Paragraph IV (Patent) Challenges for ZEGERID

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ZEGERID	Powder for Oral Suspension	omeprazole; sodium bicarbonate	20mg/1680mg per packet	021636	1	2007-11-13
ZEGERID	Powder for Oral Suspension	omeprazole; sodium bicarbonate	40 mg/1680 mg per packet	021636	1	2007-08-24
ZEGERID	Capsules	omeprazole; sodium bicarbonate	20 mg/1100 mg and 40 mg/1100 mg	021849	1	2007-04-30

US Patents and Regulatory Information for ZEGERID

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Salix	ZEGERID	omeprazole; sodium bicarbonate	CAPSULE;ORAL	021849-001	Feb 27, 2006		DISCN	Yes	No
Riley Consumer	ZEGERID OTC	omeprazole; sodium bicarbonate	CAPSULE;ORAL	022281-001	Dec 1, 2009		OTC	Yes	Yes
Salix	ZEGERID	omeprazole; sodium bicarbonate	FOR SUSPENSION;ORAL	021636-002	Dec 21, 2004		DISCN	Yes	No
Riley Consumer	ZEGERID OTC	omeprazole; sodium bicarbonate	FOR SUSPENSION;ORAL	022283-001	Jun 17, 2013		OTC	Yes	Yes
Salix	ZEGERID	omeprazole; sodium bicarbonate	CAPSULE;ORAL	021849-002	Feb 27, 2006		DISCN	Yes	No
Salix	ZEGERID	omeprazole; sodium bicarbonate	FOR SUSPENSION;ORAL	021636-001	Jun 15, 2004		DISCN	Yes	No
Santarus	ZEGERID	magnesium hydroxide; omeprazole; sodium bicarbonate	TABLET, CHEWABLE;ORAL	021850-002	Mar 24, 2006		DISCN	No	No

Expired US Patents for ZEGERID

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Santarus	ZEGERID	magnesium hydroxide; omeprazole; sodium bicarbonate	TABLET, CHEWABLE;ORAL	021850-001	Mar 24, 2006
Salix	ZEGERID	omeprazole; sodium bicarbonate	CAPSULE;ORAL	021849-002	Feb 27, 2006
Santarus	ZEGERID	magnesium hydroxide; omeprazole; sodium bicarbonate	TABLET, CHEWABLE;ORAL	021850-001	Mar 24, 2006
Salix	ZEGERID	omeprazole; sodium bicarbonate	FOR SUSPENSION;ORAL	021636-002	Dec 21, 2004
Santarus	ZEGERID	magnesium hydroxide; omeprazole; sodium bicarbonate	TABLET, CHEWABLE;ORAL	021850-002	Mar 24, 2006
Salix	ZEGERID	omeprazole; sodium bicarbonate	FOR SUSPENSION;ORAL	021636-001	Jun 15, 2004
Salix	ZEGERID	omeprazole; sodium bicarbonate	CAPSULE;ORAL	021849-001	Feb 27, 2006

International Patents for ZEGERID

See the table below for patents covering ZEGERID around the world.

Country	Patent Number	Title	Estimated Expiration
Mexico	PA04000223	FORMAS DE DOSIS DE BENCIMIDAZOL SUBSTITUIDAS NOVEDOSAS Y METODO PARA USAR LAS MISMAS. (NOVEL SUBSTITUTED BENZIMIDAZOLE DOSAGE FORMS AND METHOD OF USING SAME.)
World Intellectual Property Organization (WIPO)	03009846
Argentina	038157	FORMAS DE DOSIFICACION DE BENZIMIDAZOLES SUSTITUIDOS Y SU USO
Norway	331542
Japan	2003519656
Australia	2003214858
Israel	150696	PHARMACEUTICAL COMPOSITIONS CONTAINING BENZIMIDAZOLE DERIVATIVES AND PROCESSES FOR THE MANUFACTURE THEREOF

Supplementary Protection Certificates for ZEGERID

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1020461	300482	Netherlands		PRODUCT NAME: NAXOPREN EN ESOMEPRAZOL ALS MAGNESIUMZOUT; NATIONAL REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: GB PL 17091/0263 - 0001 20101105
1499331	13C0055	France		PRODUCT NAME: SULFATE DE SODIUM ANHYDRE, SULFATE DE MAGNESIUM HEPTAHYDRATE, SULFATE DE POTASSIUM; NAT. REGISTRATION NO/DATE: NL41696 20130426; FIRST REGISTRATION: BE - 434323 20130220
0124495	SPC/GB01/006	United Kingdom		PRODUCT NAME: ESOMEPRAZOLE AS MAGNESIUM TRIHYDRATE; REGISTERED: SE 15945 20000310; SE 15946 20000310; UK PL 17901/0068-0069 20000727
1499331	122014000007	Germany		PRODUCT NAME: NATRIUMSULFAT, MAGNESIUMSULFAT UND KALIUMSULFAT; NAT. REGISTRATION NO/DATE: 86203.00.00 20130808; FIRST REGISTRATION: BELGIEN BE434323 20130220
0984957	2012/048	Ireland		PRODUCT NAME: A COMBINATION PRODUCT COMPRISING ASPIRIN AND ESOMEPRAZOLE MAGNESIUM TRIHYDRATE; NAT REGISTRATION NO/DATE: PA 970/063/001 20120831; FIRST REGISTRATION NO/DATE: 5402359; 5402367 5402375 20110812
1411900	SPC/GB11/015	United Kingdom		PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
0984957	C300517	Netherlands		PRODUCT NAME: ACETYLSALICYLZUUR EN ESOMEPRAZOLMAGNESIUMTRIHYDRAAT; NAT. REGISTRATION NO/DATE: RVG 107516 20110912; FIRST REGISTRATION: 540235954023675402375 2011120812