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Generated: October 17, 2017

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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 hydrocodone bitartrate; ibuprofen patent protection?

Hydrocodone bitartrate; ibuprofen
is the generic ingredient in three branded drugs marketed by Actavis Labs Fl Inc, Abbvie, Teva, Vintage Pharms, Sun Pharm Inds Inc, Amneal Pharms Ny, and Aurolife Pharma Llc, and is included in nine NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

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

Summary for Generic Name: HYDROCODONE BITARTRATE; IBUPROFEN

US Patents:2
Tradenames:3
Applicants:7
NDAs:9
Drug Master File Entries: see list22
Suppliers / Packagers: see list23
Clinical Trials: see list598
Drug Prices:see low prices
DailyMed Link:HYDROCODONE BITARTRATE; IBUPROFEN at DailyMed

Pharmacology for Ingredient: 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;ORAL076642-001Oct 12, 2004ABRXNoYes► Subscribe► Subscribe► Subscribe
Abbvie
VICOPROFEN
hydrocodone bitartrate; ibuprofen
TABLET;ORAL020716-001Sep 23, 1997DISCNYesNo► Subscribe► Subscribe ► Subscribe
Abbvie
VICOPROFEN
hydrocodone bitartrate; ibuprofen
TABLET;ORAL020716-001Sep 23, 1997DISCNYesNo► Subscribe► Subscribe ► Subscribe
Vintage Pharms
HYDROCODONE BITARTRATE AND IBUPROFEN
hydrocodone bitartrate; ibuprofen
TABLET;ORAL077727-001Nov 6, 2006ABRXNoNo► Subscribe► Subscribe► Subscribe
Vintage Pharms
HYDROCODONE BITARTRATE AND IBUPROFEN
hydrocodone bitartrate; ibuprofen
TABLET;ORAL077723-002Nov 6, 2006ABRXNoNo► Subscribe► Subscribe► Subscribe
Sun Pharm Inds Inc
HYDROCODONE BITARTRATE AND IBUPROFEN
hydrocodone bitartrate; ibuprofen
TABLET;ORAL091633-001May 28, 2013ABRXNoNo► Subscribe► Subscribe► Subscribe
Amneal Pharms Ny
REPREXAIN
hydrocodone bitartrate; ibuprofen
TABLET;ORAL076642-003Oct 19, 2007ABRXNoNo► Subscribe► Subscribe► Subscribe
Actavis Labs Fl Inc
HYDROCODONE BITARTRATE AND IBUPROFEN
hydrocodone bitartrate; ibuprofen
TABLET;ORAL076604-001Dec 31, 2003ABRXNoNo► Subscribe► Subscribe► Subscribe
Sun Pharm Inds Inc
HYDROCODONE BITARTRATE AND IBUPROFEN
hydrocodone bitartrate; ibuprofen
TABLET;ORAL091633-003May 28, 2013ABRXNoNo► Subscribe► Subscribe► Subscribe
Amneal Pharms Ny
HYDROCODONE BITARTRATE AND IBUPROFEN
hydrocodone bitartrate; ibuprofen
TABLET;ORAL076642-002Mar 18, 2004ABRXNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: hydrocodone bitartrate; ibuprofen

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie
VICOPROFEN
hydrocodone bitartrate; ibuprofen
TABLET;ORAL020716-001Sep 23, 1997► Subscribe► Subscribe
Abbvie
VICOPROFEN
hydrocodone bitartrate; ibuprofen
TABLET;ORAL020716-001Sep 23, 1997► Subscribe► Subscribe
Abbvie
VICOPROFEN
hydrocodone bitartrate; ibuprofen
TABLET;ORAL020716-001Sep 23, 1997► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: hydrocodone bitartrate; ibuprofen

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,361,794 Method of making ibuprofen and narcotic analgesic composition► Subscribe
7,833,547Ibuprofen and narcotic analgesic compositions► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
McKinsey
Cipla
Cerilliant
Citi
US Army
Dow
Cantor Fitzgerald
Accenture
QuintilesIMS

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 verifification 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.

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