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Last Updated: May 28, 2020

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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 patent protection?

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

There are twenty-three drug master file entries for hydrocodone bitartrate; ibuprofen. Six suppliers are listed for this compound.

Recent Clinical Trials for hydrocodone bitartrate; ibuprofen

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SponsorPhase
CephalonPhase 1

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Recent Litigation for hydrocodone bitartrate; ibuprofen

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District Court Litigation
Case NameDate
Knoll Pharmaceutical v. TEVA Pharmaceuticals2001-03-08

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Pharmacology for hydrocodone bitartrate; ibuprofen
Paragraph IV (Patent) Challenges for HYDROCODONE BITARTRATE; IBUPROFEN
Tradename Dosage Ingredient NDA Submissiondate
VICOPROFEN TABLET;ORAL hydrocodone bitartrate; ibuprofen 020716

US Patents and Regulatory Information for hydrocodone bitartrate; ibuprofen

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Abbvie VICOPROFEN hydrocodone bitartrate; ibuprofen TABLET;ORAL 020716-001 Sep 23, 1997 DISCN Yes No   Start Trial   Start Trial   Start Trial
Teva HYDROCODONE BITARTRATE AND IBUPROFEN hydrocodone bitartrate; ibuprofen TABLET;ORAL 076023-001 Apr 11, 2003 DISCN No No   Start Trial   Start Trial   Start Trial
Amneal Pharms Ny HYDROCODONE BITARTRATE AND IBUPROFEN hydrocodone bitartrate; ibuprofen TABLET;ORAL 076642-001 Oct 12, 2004 AB RX No Yes   Start Trial   Start Trial   Start 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

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

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Serving leading biopharmaceutical companies globally:

Dow
McKinsey
Harvard Business School
Colorcon
McKesson
Express Scripts

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.