IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE - Generic Drug Details

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

Ibuprofen; pseudoephedrine hydrochloride is the generic ingredient in six branded drugs marketed by Haleon Us Holdings, Aurobindo Pharma, J And J Consumer Inc, Perrigo, Aurobindo Pharma Ltd, Contract Pharmacal, Dr Reddys Labs Ltd, and Ohm Labs, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.

Fourteen suppliers are listed for this compound.

Summary for IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE

US Patents:	0
Tradenames:	6
Applicants:	8
NDAs:	11
Finished Product Suppliers / Packagers:	14
Clinical Trials:	6
DailyMed Link:	IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE

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

Sponsor	Phase
Institut für Pharmakologie und Präventive Medizin	Phase 1
Pharma Medica Research, Inc.	Phase 1
Boehringer Ingelheim	Phase 1

See all IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE clinical trials

Pharmacology for IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE

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

US Patents and Regulatory Information for IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aurobindo Pharma Ltd	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	ibuprofen; pseudoephedrine hydrochloride	TABLET;ORAL	213565-001	Mar 10, 2023		DISCN	No	No
Aurobindo Pharma	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	ibuprofen; pseudoephedrine hydrochloride	CAPSULE;ORAL	209235-001	Dec 1, 2017		OTC	No	No
J And J Consumer Inc	CHILDREN'S MOTRIN COLD	ibuprofen; pseudoephedrine hydrochloride	SUSPENSION;ORAL	021128-001	Aug 1, 2000		OTC	Yes	Yes
J And J Consumer Inc	SINE-AID IB	ibuprofen; pseudoephedrine hydrochloride	TABLET;ORAL	019899-001	Dec 31, 1992		OTC	No	No
Dr Reddys Labs Ltd	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	ibuprofen; pseudoephedrine hydrochloride	TABLET;ORAL	077628-001	Aug 14, 2006		OTC	No	No

Expired US Patents for IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
J And J Consumer Inc	CHILDREN'S MOTRIN COLD	ibuprofen; pseudoephedrine hydrochloride	SUSPENSION;ORAL	021128-001	Aug 1, 2000
Haleon Us Holdings	ADVIL COLD AND SINUS	ibuprofen; pseudoephedrine hydrochloride	TABLET;ORAL	019771-001	Sep 19, 1989
Haleon Us Holdings	ADVIL COLD AND SINUS	ibuprofen; pseudoephedrine hydrochloride	CAPSULE;ORAL	021374-001	May 30, 2002
Haleon Us Holdings	ADVIL COLD AND SINUS	ibuprofen; pseudoephedrine hydrochloride	CAPSULE;ORAL	021374-001	May 30, 2002