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Oxycodone hydrochloride - Generic Drug Details

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Oxycodone hydrochloride is the generic ingredient in four branded drugs marketed by Novel Labs Inc, Coastal Pharms, Roxane, Mallinckrodt Inc, Vintage Pharms, Alvogen Malta, Ken Lifescience, Lannett Holdings Inc, Lehigh Valley, Actavis Elizabeth, Vistapharm, Amneal Pharms, Wockhardt Bio Ag, Sun Pharm Inds Inc, Aurolife Pharma Llc, Epic Pharma Llc, Purdue Pharma Lp, Avanthi Inc, Ani Pharms Inc, Egalet Us Inc, Nesher Pharms, Rhodes Pharms, and Corepharma, and is included in thirty-four NDAs. There are eighteen patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has four hundred and twenty-three patent family members in forty-four countries.

There are seventeen drug master file entries for oxycodone hydrochloride. Fifty-one suppliers are listed for this compound. There are six tentative approvals for this compound.

Summary for Generic Name: oxycodone hydrochloride

Tradenames:4
Patents:18
Applicants:23
NDAs:34
Drug Master File Entries: see list17
Suppliers / Packaging: see list51
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details

Pharmacology for Ingredient: oxycodone hydrochloride

Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists

Tentative approvals for OXYCODONE HYDROCHLORIDE

Applicant Application No. Form Dosage
<disabled><disabled>TABLET, EXTENDED RELEASE; ORAL10MG
<disabled><disabled>TABLET, EXTENDED RELEASE; ORAL20MG
<disabled><disabled>TABLET, EXTENDED RELEASE; ORAL40MG

Clinical Trials for: oxycodone hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Roxane
ROXICODONE
oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL020932-002Oct 26, 1998DISCNNo<disabled><disabled>
Purdue Pharma Lp
OXYCONTIN
oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022272-003Apr 5, 2010RXNo8,894,987<disabled>Y <disabled>
Sun Pharm Inds Inc
OXYCODONE HYDROCHLORIDE
oxycodone hydrochloride
TABLET;ORAL090659-002Apr 10, 2009RXNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: oxycodone hydrochloride

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Purdue Pharma Lp
OXYCONTIN
oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022272-006Apr 5, 20105,508,042<disabled>
Purdue Pharma Lp
OXYCONTIN
oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022272-003Apr 5, 20105,508,042<disabled>
Purdue Pharma Lp
OXYCONTIN
oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022272-001Apr 5, 20105,508,042<disabled>
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Non-Orange Book Patents for Generic Ingredient: oxycodone hydrochloride

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
7,674,798Oxycodone hydrochloride having less than 25 ppm 14-hydroxycodeinone<disabled in preview>
8,652,497Pharmaceutical formulation containing irritant<disabled in preview>
8,420,056Abuse-proofed dosage form<disabled in preview>
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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: oxycodone hydrochloride

Country Document Number Estimated Expiration
Austria411007<disabled in preview>
Denmark2319846<disabled in preview>
Australia2015261590<disabled in preview>
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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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Supplementary Protection Certificates for Tradename: OXYCODONE HYDROCHLORIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
292Luxembourg<disabled>PRODUCT NAME: COMBINAISON D OXYCODONE EN TANT QUE COMPOSANT A ET DE NALOXONE EN TANT QUE COMPOSANT B SOUS TOUTES LES FORMES PROTEGES PAR LE BREVET DE BASE
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