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
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Cephalon | Phase 1 |
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
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
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 | REPREXAIN | hydrocodone bitartrate; ibuprofen | TABLET;ORAL | 076642-004 | Oct 19, 2007 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Ani Pharms | HYDROCODONE BITARTRATE AND IBUPROFEN | hydrocodone bitartrate; ibuprofen | TABLET;ORAL | 077454-001 | Jun 23, 2010 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Actavis Labs Fl Inc | HYDROCODONE BITARTRATE AND IBUPROFEN | hydrocodone bitartrate; ibuprofen | TABLET;ORAL | 076604-001 | Dec 31, 2003 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Sun Pharm Inds Inc | HYDROCODONE BITARTRATE AND IBUPROFEN | hydrocodone bitartrate; ibuprofen | TABLET;ORAL | 091633-002 | May 28, 2013 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Amneal Pharms Ny | HYDROCODONE BITARTRATE AND IBUPROFEN | hydrocodone bitartrate; ibuprofen | TABLET;ORAL | 076642-002 | Mar 18, 2004 | AB | RX | 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 | |||
Teva | HYDROCODONE BITARTRATE AND IBUPROFEN | hydrocodone bitartrate; ibuprofen | TABLET;ORAL | 076023-001 | Apr 11, 2003 | 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 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 | ⤷ 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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