FAMOTIDINE; IBUPROFEN - Generic Drug Details

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What are the generic sources for famotidine; ibuprofen and what is the scope of freedom to operate?

Famotidine; ibuprofen is the generic ingredient in four branded drugs marketed by Horizon, Torrent, Endo Operations, Alkem Labs Ltd, Ascent Pharms Inc, and Teva Pharms Usa, and is included in six NDAs. There are five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Famotidine; ibuprofen has twenty-five patent family members in fifteen countries.

Eleven suppliers are listed for this compound.

Summary for FAMOTIDINE; IBUPROFEN

International Patents:	25
US Patents:	5
Tradenames:	4
Applicants:	6
NDAs:	6
Finished Product Suppliers / Packagers:	11
Clinical Trials:	6
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FAMOTIDINE; IBUPROFEN
DailyMed Link:	FAMOTIDINE; IBUPROFEN at DailyMed

Recent Clinical Trials for FAMOTIDINE; IBUPROFEN

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

Sponsor	Phase
Duke University	Phase 4
Pediatric Rheumatology Collaborative Study Group	Phase 4
Horizon Pharma Ireland, Ltd., Dublin Ireland	Phase 4

See all FAMOTIDINE; IBUPROFEN clinical trials

Pharmacology for FAMOTIDINE; IBUPROFEN

Drug Class	Histamine-2 Receptor Antagonist Nonsteroidal Anti-inflammatory Drug
Mechanism of Action	Cyclooxygenase Inhibitors Histamine H2 Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for FAMOTIDINE; IBUPROFEN

A02BA	H2-receptor antagonists
A02B	DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
A02	DRUGS FOR ACID RELATED DISORDERS
A	Alimentary tract and metabolism

C01EB	Other cardiac preparations
C01E	OTHER CARDIAC PREPARATIONS
C01	CARDIAC THERAPY
C	Cardiovascular system

G02CC	Antiinflammatory products for vaginal administration
G02C	OTHER GYNECOLOGICALS
G02	OTHER GYNECOLOGICALS
G	Genito-urinary system and sex hormones

M01AE	Propionic acid derivatives
M01A	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
M01	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
M	Musculo-skeletal system

M02AA	Antiinflammatory preparations, non-steroids for topical use
M02A	TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
M02	TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
M	Musculo-skeletal system

R02AX	Other throat preparations
R02A	THROAT PREPARATIONS
R02	THROAT PREPARATIONS
R	Respiratory system

Paragraph IV (Patent) Challenges for FAMOTIDINE; IBUPROFEN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
DUEXIS	Tablets	famotidine; ibuprofen	800 mg/26.6 mg	022519	1	2011-12-06

US Patents and Regulatory Information for FAMOTIDINE; IBUPROFEN

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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
Teva Pharms Usa	IBUPROFEN AND FAMOTIDINE	famotidine; ibuprofen	TABLET;ORAL	211278-001	Oct 29, 2021	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ascent Pharms Inc	IBUPROFEN AND FAMOTIDINE	famotidine; ibuprofen	TABLET;ORAL	216814-001	Mar 15, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Torrent	FAMOTIDINE AND IBUPROFEN	famotidine; ibuprofen	TABLET;ORAL	215925-001	Mar 18, 2024		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Alkem Labs Ltd	IBUPROFEN AND FAMOTIDINE	famotidine; ibuprofen	TABLET;ORAL	211890-001	Aug 3, 2021	AB	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Horizon	DUEXIS	famotidine; ibuprofen	TABLET;ORAL	022519-001	Apr 23, 2011		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Horizon	DUEXIS	famotidine; ibuprofen	TABLET;ORAL	022519-001	Apr 23, 2011		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for FAMOTIDINE; IBUPROFEN

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Country	Patent Number	Title	Estimated Expiration
China	101257800	Medicaments containing famotidine and ibuprofen and administration of same	⤷ Sign Up
Canada	2615496	MEDICAMENTS CONTENANT FAMOTIDINE ET IBUPROFENE, ET ADMINISTRATION DESDITS MEDICAMENTS (MEDICAMENTS CONTAINING FAMOTIDINE AND IBUPROFEN AND ADMINISTRATION OF SAME)	⤷ Sign Up
Canada	2657928	PROCEDES ET MEDICAMENTS DESTINES A L'ADMINISTRATION D'IBUPROFENE (METHODS AND MEDICAMENTS FOR ADMINISTRATION OF IBUPROFEN)	⤷ Sign Up
Australia	2006269894	Medicaments containing famotidine and ibuprofen and administration of same	⤷ Sign Up
Spain	2380747		⤷ Sign Up
Australia	2007275360	Methods and medicaments for administration of ibuprofen	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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