PEPCID COMPLETE Drug Patent Profile

When do Pepcid Complete patents expire, and when can generic versions of Pepcid Complete launch?

Pepcid Complete is a drug marketed by J And J Consumer Inc and is included in one NDA.

The generic ingredient in PEPCID COMPLETE is calcium carbonate; famotidine; magnesium hydroxide. There are two hundred and eighty-two drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the calcium carbonate; famotidine; magnesium hydroxide profile page.

Summary for PEPCID COMPLETE

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	71
Clinical Trials:	35
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PEPCID COMPLETE
What excipients (inactive ingredients) are in PEPCID COMPLETE?	PEPCID COMPLETE excipients list
DailyMed Link:	PEPCID COMPLETE at DailyMed

Recent Clinical Trials for PEPCID COMPLETE

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

Sponsor	Phase
Ohio State University Comprehensive Cancer Center	Phase 2/Phase 3
United States Department of Defense	Phase 2
Leidos Life Sciences	Phase 2

See all PEPCID COMPLETE clinical trials

Pharmacology for PEPCID COMPLETE

Drug Class	Histamine-2 Receptor Antagonist
Mechanism of Action	Histamine H2 Receptor Antagonists

Paragraph IV (Patent) Challenges for PEPCID COMPLETE

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 PEPCID COMPLETE

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	PEPCID COMPLETE	calcium carbonate; famotidine; magnesium hydroxide	TABLET, CHEWABLE;ORAL	020958-001	Oct 16, 2000		OTC	Yes	Yes

Expired US Patents for PEPCID COMPLETE

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
J And J Consumer Inc	PEPCID COMPLETE	calcium carbonate; famotidine; magnesium hydroxide	TABLET, CHEWABLE;ORAL	020958-001	Oct 16, 2000
J And J Consumer Inc	PEPCID COMPLETE	calcium carbonate; famotidine; magnesium hydroxide	TABLET, CHEWABLE;ORAL	020958-001	Oct 16, 2000
J And J Consumer Inc	PEPCID COMPLETE	calcium carbonate; famotidine; magnesium hydroxide	TABLET, CHEWABLE;ORAL	020958-001	Oct 16, 2000
J And J Consumer Inc	PEPCID COMPLETE	calcium carbonate; famotidine; magnesium hydroxide	TABLET, CHEWABLE;ORAL	020958-001	Oct 16, 2000
J And J Consumer Inc	PEPCID COMPLETE	calcium carbonate; famotidine; magnesium hydroxide	TABLET, CHEWABLE;ORAL	020958-001	Oct 16, 2000

International Patents for PEPCID COMPLETE

See the table below for patents covering PEPCID COMPLETE around the world.

Country	Patent Number	Title	Estimated Expiration
Greece	1002397	ΦΑΡΜΑΚΕΥΤΙΚΗ ΣΥΝΘΕΣΗ ΠΟΥ ΠΕΡΙΕΧΕΙ ΜΙΑ ΓΟΥΑΝΙΔΙΝΟΘΕΙΑΖΟΛΙΚΗ ΕΝΩΣΗ ΚΑΙ ΑΝΤΙΟΞΙΝΑ. (Pharmaceutical composition containing a guanidinothiazole compound and antacids.)
Austria	A103080
Greece	67011
Canada	2052679	ROTOGRANULATIONS ET ENROBAGES MASQUANT LES SAVEURS DANS LA PREPARATION DE COMPRIMES PHARMACEUTIQUES A CROQUER (ROTOGRANULATIONS AND TASTE MASKING COATINGS FOR PREPARATION OF CHEWABLE PHARMACEUTICAL TABLETS)
Sweden	444317	NYA GUANIDINOTIAZOLFORENINGAR SAMT FARMACEUTISKA KOMPOSITIONER DERAV
Japan	H06219939	ROTATING TABLET-FORMING AND TASTE-COVERING COATING PROCESSING FOR PREPARING CHEWABLE MEDICAL TABLET

Supplementary Protection Certificates for PEPCID COMPLETE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0720599	CR 2014 00050	Denmark		PRODUCT NAME: EZETIMIBE AND ATORVASTATIN OR PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, INCLUDING ATORVASTATIN AS ATORVASTATIN CALCIUM TRIHYDRATE; REG. NO/DATE: DE/H/3895-3898/001-004/DC 20140910
0720599	300689	Netherlands		PRODUCT NAME: EZETIMIBE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN ATORVASTATINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER ATORVASTATINE CALCIUM TRIHYDRATE; NATIONAL REGISTRATION NO/DATE: RVG114373-114376 20141027; FIRST REGISTRATION: FR 2014091200122 20140912
2957286	122018000145	Germany		PRODUCT NAME: PATIROMER SORBITEX CALCIUM; REGISTRATION NO/DATE: EU/1/17/1179 20170719
0521471	C300125	Netherlands		PRODUCT NAME: ROSUVASTATINUM, DESGEWENST IN DE VORM VAN EEN NIET-TOXISCH FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET CALCIUMZOUT; REGISTRATION NO/DATE: RVG 26872 - RVG 26874 20021106
0933372	SPC/GB08/018	United Kingdom		PRODUCT NAME: FOSAMPRENAVIR CALCIUM: ((1S,2R)-3-(((4-AMINOPHENYL)SULFONYL)(2-METHYLPROPYL)AMINO)-1-(PHENYLMETHYL)-2(PHOSPHONOOXY)PROPYL)-CARBABAMIC ACID C-((3S)-TETRAHYDRO-3-FURANYL) ESTER CALCIUM SALT; REGISTERED: UK EU/1/04/282/001 20040712; UK EU/1/04/282/002 20040712
2957286	2018C/047	Belgium		PRODUCT NAME: PATIROMER SORBITEX CALCIUM; AUTHORISATION NUMBER AND DATE: EU/1/17/1179 20170721