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Last Updated: June 6, 2020

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OXYCODONE - Generic Drug Details

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What are the generic sources for oxycodone and what is the scope of freedom to operate?

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, Alkem Labs Ltd, Ascent Pharms Inc, Aurolife Pharma Llc, Eywa, Hi Tech, 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 Inspirion Delivery, and is included in fifty-two NDAs. There are forty-seven 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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Generic filers with tentative approvals for OXYCODONE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial80MGTABLET, EXTENDED RELEASE; ORAL
  Start Trial  Start Trial80MGTABLET, EXTENDED RELEASE; ORAL
  Start Trial  Start Trial40MGTABLET, 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 022272-002 Apr 5, 2010 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Purdue Pharma Lp OXYCONTIN oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022272-007 Apr 5, 2010 RX Yes No   Start Trial   Start Trial Y   Start Trial
Purdue Pharma Lp OXYCONTIN oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022272-001 Apr 5, 2010 RX Yes No   Start Trial   Start Trial Y   Start Trial
Ani Pharms Inc OXYCODONE HYDROCHLORIDE oxycodone hydrochloride SOLUTION;ORAL 204979-001 Jun 1, 2015 AA RX No No   Start Trial   Start Trial   Start Trial
Mayne Pharma Inc OXYCODONE HYDROCHLORIDE oxycodone hydrochloride TABLET;ORAL 091313-001 Feb 18, 2011 AB RX No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for OXYCODONE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1685839 92292 Luxembourg   Start Trial 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:

Baxter
Mallinckrodt
Harvard Business School
McKesson
Dow
Boehringer Ingelheim

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