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OXYCONTIN Drug Profile

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Oxycontin is a drug marketed by Purdue Pharma Lp and is included in one NDA. It is available from eight suppliers. There are thirteen patents protecting this drug and seven Paragraph IV challenges.

This drug has four hundred and twelve patent family members in forty-four countries.

The generic ingredient in OXYCONTIN is oxycodone hydrochloride. There are seventeen drug master file entries for this compound. Fifty-one suppliers are listed for this compound. There are six tentative approvals for this compound. Additional details are available on the oxycodone hydrochloride profile page.

Summary for Tradename: OXYCONTIN

Patents:13
Applicants:1
NDAs:1
Suppliers / Packagers: see list8

Pharmacology for Tradename: OXYCONTIN

Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists

Clinical Trials for: OXYCONTIN

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Purdue Pharma Lp
OXYCONTIN
oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022272-005Apr 5, 2010RXYes8,337,888<disabled>Y <disabled>
Purdue Pharma Lp
OXYCONTIN
oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022272-007Apr 5, 2010RXNo<disabled><disabled>
Purdue Pharma Lp
OXYCONTIN
oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022272-003Apr 5, 2010RXNo6,488,963<disabled>Y <disabled>
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Expired Patents for Tradename: OXYCONTIN

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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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Paragraph IV activity for: OXYCONTIN

Drugname Dosage Strength RLD Submissiondate
oxycodone hydrochlorideExtended-release Tablet40 mgOxyContin (NDA 022272)10/4/2010
oxycodone hydrochlorideExtended-release Tablet30 mg, 60 mg and 80 mgOxyContin (NDA 022272)10/18/2010
oxycodone hydrochlorideExtended-release Tablet20 mgOxyContin (NDA 022272)10/29/2010
oxycodone hydrochlorideExtended-release Tablet15 mgOxyContin (NDA 022272)10/28/2010
oxycodone hydrochlorideExtended-release Tablet10 mgOxyContin (NDA 022272)10/25/2010
oxycodone hydrochlorideExtended-release Tablets15 mgOxycontin2/15/2007
oxycodone hydrochlorideExtended-release Tablets30 mg and 60 mgOxycontin1/3/2007

Non-Orange Book Patents for Tradename: OXYCONTIN

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
7,332,182Pharmaceutical formulation containing opioid agonist, opioid antagonist and irritant<disabled in preview>
8,795,156Methods for manipulating a channel within a medical device<disabled in preview>
8,192,722Abuse-proof 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 Tradename: OXYCONTIN

Country Document Number Estimated Expiration
Slovenia2292230<disabled in preview>
MexicoPA04001208<disabled in preview>
New Zealand602862<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: OXYCONTIN

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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