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Last Updated: April 23, 2024

Famotidine; ibuprofen - Generic Drug Details

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What are the generic drug sources for famotidine; ibuprofen and what is the scope of patent protection?

Famotidine; ibuprofen is the generic ingredient in two branded drugs marketed by Horizon, Alkem Labs Ltd, Ascent Pharms Inc, and Teva Pharms Usa, and is included in four 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.

Eight suppliers are listed for this compound.

Summary for famotidine; ibuprofen

International Patents:	25
US Patents:	5
Tradenames:	2
Applicants:	4
NDAs:	4
Finished Product Suppliers / Packagers:	8
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
Horizon Pharma Ireland, Ltd., Dublin Ireland	Phase 4
Pediatric Rheumatology Collaborative Study Group	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

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	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Horizon	DUEXIS	famotidine; ibuprofen	TABLET;ORAL	022519-001	Apr 23, 2011		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Horizon	DUEXIS	famotidine; ibuprofen	TABLET;ORAL	022519-001	Apr 23, 2011		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
>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
Portugal	2043637		⤷ Try a Trial
China	101257800	Medicaments containing famotidine and ibuprofen and administration of same	⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2007012022		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.