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 | 076642-003 | Oct 19, 2007 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Abbvie | VICOPROFEN | hydrocodone bitartrate; ibuprofen | TABLET;ORAL | 020716-001 | Sep 23, 1997 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sun Pharm Inds Inc | HYDROCODONE BITARTRATE AND IBUPROFEN | hydrocodone bitartrate; ibuprofen | TABLET;ORAL | 091633-001 | May 28, 2013 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sun Pharm Inds Inc | HYDROCODONE BITARTRATE AND IBUPROFEN | hydrocodone bitartrate; ibuprofen | TABLET;ORAL | 091633-003 | May 28, 2013 | DISCN | 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 | ||||
| Nostrum Labs Inc | HYDROCODONE BITARTRATE AND IBUPROFEN | hydrocodone bitartrate; ibuprofen | TABLET;ORAL | 077723-002 | Nov 6, 2006 | 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
| 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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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.
ISSN: 2162-2639
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