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Hydrocodone bitartrate - Generic Drug Details

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Hydrocodone bitartrate is the generic ingredient in eight branded drugs marketed by Purdue Pharma Lp, Pernix Ireland Pain, Actavis Labs Fl Inc, Abbvie, Teva, Vintage Pharms, Sun Pharm Inds Inc, Amneal Pharms Ny, Aurolife Pharma Llc, Alpharma Us Pharms, Tris Pharma Inc, Cypress Pharm, Coastal Pharms, and Paddock Llc, and is included in sixteen NDAs. There are thirty-two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has five hundred and thirty-two patent family members in forty-nine countries.

There are twenty-two drug master file entries for hydrocodone bitartrate. Three suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: hydrocodone bitartrate

Tradenames:8
Patents:32
Applicants:14
NDAs:16
Drug Master File Entries: see list22
Suppliers / Packaging: see list3
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: hydrocodone bitartrate

Drug ClassOpioid Agonist
Mechanism of ActionOpioid Agonists

Tentative approvals for HYDROCODONE BITARTRATE

Applicant Application No. Form Dosage
<disabled><disabled>CAPSULE, EXTENDED RELEASE;ORAL10MG
<disabled><disabled>CAPSULE, EXTENDED RELEASE;ORAL15MG
<disabled><disabled>CAPSULE, EXTENDED RELEASE;ORAL20MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Purdue Pharma Lp
HYSINGLA
hydrocodone bitartrate
TABLET, EXTENDED RELEASE;ORAL206627-001Nov 20, 2014RXYes9,023,401► subscribeY ► subscribe
Pernix Ireland Pain
ZOHYDRO ER
hydrocodone bitartrate
CAPSULE, EXTENDED RELEASE;ORAL202880-004Oct 25, 2013RXNo6,228,398► subscribeY ► subscribe
Pernix Ireland Pain
ZOHYDRO ER
hydrocodone bitartrate
CAPSULE, EXTENDED RELEASE;ORAL202880-006Oct 25, 2013RXNo9,339,499► subscribe ► subscribe
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Non-Orange Book Patents for Generic Ingredient: hydrocodone bitartrate

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
7,727,557Pharmaceutical formulation containing irritant► subscribe
8,142,811Controlled release hydrocodone formulations► subscribe
9,060,976Pharmaceutical formulation containing gelling agent► 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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International Patent Family for Ingredient: hydrocodone bitartrate

Country Document Number Estimated Expiration
Japan5069300► subscribe
Singapore10201510564P► subscribe
Israel217794► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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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 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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