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Last Updated: September 23, 2021

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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, Aurolife Pharma Llc, Nostrum Labs Inc, Sun Pharm Inds Inc, Teva, 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.

Summary for hydrocodone bitartrate; ibuprofen
Recent Clinical Trials for hydrocodone bitartrate; ibuprofen

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

SponsorPhase
CephalonPhase 1

See all hydrocodone bitartrate; ibuprofen clinical trials

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 2006-03-20
VICOPROFEN TABLET;ORAL hydrocodone bitartrate; ibuprofen 020716 2006-02-24

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
Amneal Pharms Ny HYDROCODONE BITARTRATE AND IBUPROFEN hydrocodone bitartrate; ibuprofen TABLET;ORAL 076642-002 Mar 18, 2004 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Aurolife Pharma Llc HYDROCODONE BITARTRATE AND IBUPROFEN hydrocodone bitartrate; ibuprofen TABLET;ORAL 204575-001 Jun 2, 2016 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Nostrum Labs Inc HYDROCODONE BITARTRATE AND IBUPROFEN hydrocodone bitartrate; ibuprofen TABLET;ORAL 077727-001 Nov 6, 2006 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Amneal Pharms Ny REPREXAIN hydrocodone bitartrate; ibuprofen TABLET;ORAL 076642-003 Oct 19, 2007 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Nostrum Labs Inc HYDROCODONE BITARTRATE AND IBUPROFEN hydrocodone bitartrate; ibuprofen TABLET;ORAL 077723-002 Nov 6, 2006 RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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 ⤷  Try it Free ⤷  Try it Free
Abbvie VICOPROFEN hydrocodone bitartrate; ibuprofen TABLET;ORAL 020716-001 Sep 23, 1997 ⤷  Try it Free ⤷  Try it Free
Abbvie VICOPROFEN hydrocodone bitartrate; ibuprofen TABLET;ORAL 020716-001 Sep 23, 1997 ⤷  Try it Free ⤷  Try it Free
>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

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