IBUPROFEN; OXYCODONE HYDROCHLORIDE - Generic Drug Details

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

Ibuprofen; oxycodone hydrochloride is the generic ingredient in two branded drugs marketed by Forest Labs, Actavis Elizabeth, Barr Labs Inc, and Watson Labs, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

Summary for IBUPROFEN; OXYCODONE HYDROCHLORIDE

US Patents:	0
Tradenames:	2
Applicants:	4
NDAs:	4
Clinical Trials:	72
DailyMed Link:	IBUPROFEN; OXYCODONE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for IBUPROFEN; OXYCODONE HYDROCHLORIDE

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

Sponsor	Phase
Henry Ford Health System	Phase 4
Jessyka Lighthall	Phase 3
Bahrain Defence Force Hospital	Phase 4

See all IBUPROFEN; OXYCODONE HYDROCHLORIDE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for IBUPROFEN; OXYCODONE HYDROCHLORIDE

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

N02AA	Natural opium alkaloids
N02A	OPIOIDS
N02	ANALGESICS
N	Nervous system

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

US Patents and Regulatory Information for IBUPROFEN; OXYCODONE 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
Watson Labs	OXYCODONE HYDROCHLORIDE AND IBUPROFEN	ibuprofen; oxycodone hydrochloride	TABLET;ORAL	078394-001	Nov 26, 2007		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Actavis Elizabeth	OXYCODONE HYDROCHLORIDE AND IBUPROFEN	ibuprofen; oxycodone hydrochloride	TABLET;ORAL	078769-001	Jan 4, 2008		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Barr Labs Inc	OXYCODONE HYDROCHLORIDE AND IBUPROFEN	ibuprofen; oxycodone hydrochloride	TABLET;ORAL	078316-001	Nov 29, 2007		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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; OXYCODONE HYDROCHLORIDE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Forest Labs	COMBUNOX	ibuprofen; oxycodone hydrochloride	TABLET;ORAL	021378-001	Nov 26, 2004	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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