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Last Updated: May 8, 2021

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Oxycodone - Generic Drug Details

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What are the generic drug sources for oxycodone and what is the scope of patent protection?

Oxycodone is the generic ingredient in six branded drugs marketed by Collegium Pharm Inc, Ani Pharms Inc, Avanthi Inc, Genus Lifesciences, Lannett Co Inc, Mayne Pharma Inc, Novel Labs Inc, Abhai Llc, Akorn, Alkem Labs Ltd, Ascent Pharms Inc, Aurolife Pharma Llc, Eywa, Hikma, Pharm Assoc, Rhodes Pharms, Specgx Llc, Vistapharm, Wockhardt Bio Ag, Purdue Pharma Lp, Roxane, Zyla, Actavis Elizabeth, Alvogen, Amneal Pharms, Epic Pharma Llc, Nesher Pharms, Nuvo Pharm, Sun Pharm Inds Inc, Vintage Pharms, and Ohemo Life, and is included in fifty-two NDAs. There are fifty patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Oxycodone has twenty-four patent family members in thirteen countries.

There are nineteen drug master file entries for oxycodone. One supplier is listed for this compound. There are four tentative approvals for this compound.

Drug Prices for oxycodone

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Drug Sales Revenue Trends for oxycodone

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Recent Clinical Trials for oxycodone

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Medical College of WisconsinPhase 2
George Clinical Pty LtdPhase 3
WriteSource Medical Pty LtdPhase 3

See all oxycodone clinical trials

Generic filers with tentative approvals for OXYCODONE
Applicant Application No. Strength Dosage Form
  Get Started for $10  Get Started for $1080MGTABLET, EXTENDED RELEASE; ORAL
  Get Started for $10  Get Started for $1080MGTABLET, EXTENDED RELEASE; ORAL
  Get Started for $10  Get Started for $1040MGTABLET, EXTENDED RELEASE; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for oxycodone
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for oxycodone
Paragraph IV (Patent) Challenges for OXYCODONE
Tradename Dosage Ingredient NDA Submissiondate
XTAMPZA ER CAPSULE, EXTENDED RELEASE;ORAL oxycodone 208090 2017-11-15

US Patents and Regulatory Information for oxycodone

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Purdue Pharma Lp OXYCONTIN oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022272-005 Apr 5, 2010 RX Yes Yes   Get Started for $10   Get Started for $10 Y   Get Started for $10
Purdue Pharma Lp OXYCONTIN oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022272-007 Apr 5, 2010 RX Yes No   Get Started for $10   Get Started for $10 Y   Get Started for $10
Collegium Pharm Inc XTAMPZA ER oxycodone CAPSULE, EXTENDED RELEASE;ORAL 208090-005 Apr 26, 2016 RX Yes Yes   Get Started for $10   Get Started for $10 Y   Get Started for $10
Collegium Pharm Inc XTAMPZA ER oxycodone CAPSULE, EXTENDED RELEASE;ORAL 208090-002 Apr 26, 2016 RX Yes No   Get Started for $10   Get Started for $10 Y   Get Started for $10
Genus Lifesciences OXYCODONE HYDROCHLORIDE oxycodone hydrochloride SOLUTION;ORAL 200535-001 Oct 20, 2010 AA RX Yes Yes   Get Started for $10   Get Started for $10   Get Started for $10
Collegium Pharm Inc XTAMPZA ER oxycodone CAPSULE, EXTENDED RELEASE;ORAL 208090-004 Apr 26, 2016 RX Yes No   Get Started for $10   Get Started for $10 Y   Get Started for $10
Vistapharm OXYCODONE HYDROCHLORIDE oxycodone hydrochloride SOLUTION;ORAL 201194-001 Jan 12, 2012 AA RX Yes Yes   Get Started for $10   Get Started for $10   Get Started for $10
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for oxycodone

Country Patent Number Estimated Expiration
Japan 2015166402   Get Started for $10
Hungary E037643   Get Started for $10
Denmark 1765292   Get Started for $10
Canada 2916869   Get Started for $10
World Intellectual Property Organization (WIPO) 2004004693   Get Started for $10
Japan 4694207   Get Started for $10
European Patent Office 1765292   Get Started for $10
>Country >Patent Number >Estimated Expiration

Supplementary Protection Certificates for oxycodone

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1685839 92292 Luxembourg   Get Started for $10 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Medtronic
McKinsey
Dow
Mallinckrodt
McKesson
Moodys

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