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Last Updated: April 19, 2024

Hydrocodone bitartrate; ibuprofen - Generic Drug Details

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

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

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
Sun Pharm Inds Inc	HYDROCODONE BITARTRATE AND IBUPROFEN	hydrocodone bitartrate; ibuprofen	TABLET;ORAL	091633-003	May 28, 2013		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Ani Pharms	HYDROCODONE BITARTRATE AND IBUPROFEN	hydrocodone bitartrate; ibuprofen	TABLET;ORAL	077454-001	Jun 23, 2010		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Sun Pharm Inds Inc	HYDROCODONE BITARTRATE AND IBUPROFEN	hydrocodone bitartrate; ibuprofen	TABLET;ORAL	091633-004	May 28, 2013		DISCN	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 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	⤷ Try a Trial	⤷ Try a Trial
Abbvie	VICOPROFEN	hydrocodone bitartrate; ibuprofen	TABLET;ORAL	020716-001	Sep 23, 1997	⤷ Try a Trial	⤷ Try a Trial
Abbvie	VICOPROFEN	hydrocodone bitartrate; ibuprofen	TABLET;ORAL	020716-001	Sep 23, 1997	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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