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Last Updated: April 19, 2024

Ibuprofen; phenylephrine hydrochloride - Generic Drug Details

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

Ibuprofen; phenylephrine hydrochloride is the generic ingredient in two branded drugs marketed by Haleon Us Holdings and Perrigo R And D, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

Seven suppliers are listed for this compound.

Summary for ibuprofen; phenylephrine hydrochloride

US Patents:	0
Tradenames:	2
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	7
Clinical Trials:	3
DailyMed Link:	ibuprofen; phenylephrine hydrochloride at DailyMed

Recent Clinical Trials for ibuprofen; phenylephrine hydrochloride

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

Sponsor	Phase
Ache Laboratorios Farmaceuticos S.A.	Phase 3
Pfizer	Phase 3
Hospital Italiano de Buenos Aires	Phase 4

See all ibuprofen; phenylephrine hydrochloride clinical trials

Pharmacology for ibuprofen; phenylephrine hydrochloride

Drug Class	Nonsteroidal Anti-inflammatory Drug alpha-1 Adrenergic Agonist
Mechanism of Action	Adrenergic alpha1-Agonists Cyclooxygenase Inhibitors

US Patents and Regulatory Information for ibuprofen; phenylephrine hydrochloride

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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
Haleon Us Holdings	ADVIL CONGESTION RELIEF	ibuprofen; phenylephrine hydrochloride	TABLET;ORAL	022565-001	May 27, 2010		OTC	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Perrigo R And D	IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE	ibuprofen; phenylephrine hydrochloride	TABLET;ORAL	203200-001	Jul 3, 2014		OTC	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ 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

Expired US Patents for ibuprofen; phenylephrine hydrochloride

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Haleon Us Holdings	ADVIL CONGESTION RELIEF	ibuprofen; phenylephrine hydrochloride	TABLET;ORAL	022565-001	May 27, 2010	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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