HYDROCODONE BITARTRATE; IBUPROFEN - Generic Drug Details

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

Hydrocodone bitartrate; ibuprofen is the generic ingredient in four branded drugs marketed by Nostrum Labs Inc, Actavis Labs Fl Inc, Amneal Pharms Ny, Ani Pharms, Aurolife Pharma Llc, Sun Pharm Inds Inc, Teva, and Abbvie, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

Three suppliers are listed for this compound.

Summary for HYDROCODONE BITARTRATE; IBUPROFEN

US Patents:	0
Tradenames:	4
Applicants:	8
NDAs:	8
Finished Product Suppliers / Packagers:	3
Clinical Trials:	1
DailyMed Link:	HYDROCODONE BITARTRATE; IBUPROFEN at DailyMed

Recent Clinical Trials for HYDROCODONE BITARTRATE; IBUPROFEN

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Sponsor	Phase
Cephalon	Phase 1

See all HYDROCODONE BITARTRATE; IBUPROFEN clinical trials

Pharmacology for HYDROCODONE BITARTRATE; IBUPROFEN

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

Anatomical Therapeutic Chemical (ATC) Classes for HYDROCODONE BITARTRATE; IBUPROFEN

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

R05DA	Opium alkaloids and derivatives
R05D	COUGH SUPPRESSANTS, EXCL. COMBINATIONS WITH EXPECTORANTS
R05	COUGH AND COLD PREPARATIONS
R	Respiratory system

Paragraph IV (Patent) Challenges for HYDROCODONE BITARTRATE; IBUPROFEN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VICOPROFEN	Tablets	hydrocodone bitartrate; ibuprofen	10 mg/200 mg	020716	1	2006-03-20
VICOPROFEN	Tablets	hydrocodone bitartrate; ibuprofen	2.5 mg/200 mg	020716	1	2006-02-24

US Patents and Regulatory Information for HYDROCODONE BITARTRATE; 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	HYDROCODONE BITARTRATE AND IBUPROFEN	hydrocodone bitartrate; ibuprofen	TABLET;ORAL	076023-001	Apr 11, 2003		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Amneal Pharms Ny	REPREXAIN	hydrocodone bitartrate; ibuprofen	TABLET;ORAL	076642-003	Oct 19, 2007		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Nostrum Labs Inc	HYDROCODONE BITARTRATE AND IBUPROFEN	hydrocodone bitartrate; ibuprofen	TABLET;ORAL	077723-001	Nov 6, 2006	AB	RX	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 HYDROCODONE BITARTRATE; IBUPROFEN

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	VICOPROFEN	hydrocodone bitartrate; ibuprofen	TABLET;ORAL	020716-001	Sep 23, 1997	⤷ Sign Up	⤷ Sign Up
Abbvie	VICOPROFEN	hydrocodone bitartrate; ibuprofen	TABLET;ORAL	020716-001	Sep 23, 1997	⤷ Sign Up	⤷ Sign Up
Abbvie	VICOPROFEN	hydrocodone bitartrate; ibuprofen	TABLET;ORAL	020716-001	Sep 23, 1997	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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