CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE - Generic Drug Details

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What are the generic sources for calcium carbonate; famotidine; magnesium hydroxide and what is the scope of patent protection?

Calcium carbonate; famotidine; magnesium hydroxide is the generic ingredient in two branded drugs marketed by Perrigo R And D and J And J Consumer Inc, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

Twenty-three suppliers are listed for this compound.

Summary for CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE

US Patents:	0
Tradenames:	2
Applicants:	2
NDAs:	3
Finished Product Suppliers / Packagers:	23
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE
DailyMed Link:	CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE at DailyMed

Pharmacology for CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE

Drug Class	Calculi Dissolution Agent Histamine-2 Receptor Antagonist Osmotic Laxative
Mechanism of Action	Histamine H2 Receptor Antagonists Magnesium Ion Exchange Activity Osmotic Activity
Physiological Effect	Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption Inhibition Small Intestine Fluid/Electrolyte Absorption Stimulation Large Intestine Fluid/Electrolyte Secretion

Anatomical Therapeutic Chemical (ATC) Classes for CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE

Paragraph IV (Patent) Challenges for CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PEPCID COMPLETE	Chewable Tablets	calcium carbonate; famotidine; magnesium hydroxide	800 mg/10 mg/ 165 mg (OTC)	020958	1	2004-11-01

US Patents and Regulatory Information for CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Perrigo R And D	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	calcium carbonate; famotidine; magnesium hydroxide	TABLET, CHEWABLE;ORAL	204782-001	Aug 29, 2016		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
J And J Consumer Inc	PEPCID COMPLETE	calcium carbonate; famotidine; magnesium hydroxide	TABLET, CHEWABLE;ORAL	020958-001	Oct 16, 2000		OTC	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Perrigo R And D	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	calcium carbonate; famotidine; magnesium hydroxide	TABLET, CHEWABLE;ORAL	077355-001	Feb 6, 2008		OTC	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
J And J Consumer Inc	PEPCID COMPLETE	calcium carbonate; famotidine; magnesium hydroxide	TABLET, CHEWABLE;ORAL	020958-001	Oct 16, 2000	⤷ Sign Up	⤷ Sign Up
J And J Consumer Inc	PEPCID COMPLETE	calcium carbonate; famotidine; magnesium hydroxide	TABLET, CHEWABLE;ORAL	020958-001	Oct 16, 2000	⤷ Sign Up	⤷ Sign Up
J And J Consumer Inc	PEPCID COMPLETE	calcium carbonate; famotidine; magnesium hydroxide	TABLET, CHEWABLE;ORAL	020958-001	Oct 16, 2000	⤷ Sign Up	⤷ Sign Up
J And J Consumer Inc	PEPCID COMPLETE	calcium carbonate; famotidine; magnesium hydroxide	TABLET, CHEWABLE;ORAL	020958-001	Oct 16, 2000	⤷ Sign Up	⤷ Sign Up
J And J Consumer Inc	PEPCID COMPLETE	calcium carbonate; famotidine; magnesium hydroxide	TABLET, CHEWABLE;ORAL	020958-001	Oct 16, 2000	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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