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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 twelve 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-nine suppliers are listed for this compound. There are seven 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 list12
Drug Prices: :see details

Pharmacology for Tradename: OXYCONTIN

Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
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► subscribeY ► subscribe
Purdue Pharma Lp
OXYCONTIN
oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022272-007Apr 5, 2010RXNo► subscribe► subscribe
Purdue Pharma Lp
OXYCONTIN
oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022272-003Apr 5, 2010RXNo6,488,963► subscribeY ► subscribe
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Expired Patents for Tradename: OXYCONTIN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Purdue Pharma Lp
OXYCONTIN
oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022272-001Apr 5, 20105,508,042► subscribe
Purdue Pharma Lp
OXYCONTIN
oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022272-003Apr 5, 20105,508,042► subscribe
Purdue Pharma Lp
OXYCONTIN
oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022272-002Apr 5, 20105,508,042► subscribe
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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
8,017,148Pharmaceutical formulation containing opioid agonist, opioid antagonist and irritant agent► subscribe
9,040,084Pharmaceutical formulation containing gelling agent► subscribe
7,727,557Pharmaceutical formulation containing irritant► 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 Tradename: OXYCONTIN

Country Document Number Estimated Expiration
Denmark2082742► subscribe
Israel217792► subscribe
Slovenia2426132► 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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Supplementary Protection Certificates for Tradename: OXYCONTIN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
292Luxembourg► subscribePRODUCT 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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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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