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Last Updated: June 6, 2020

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OXYCODONE HYDROCHLORIDE - Generic Drug Details

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

Oxycodone hydrochloride is the generic ingredient in five branded drugs marketed by 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-one NDAs. There are thirty patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Oxycodone hydrochloride has six hundred and seventeen patent family members in forty-eight countries.

There are nineteen drug master file entries for oxycodone hydrochloride. Forty-two suppliers are listed for this compound. There are four tentative approvals for this compound.

Generic filers with tentative approvals for OXYCODONE HYDROCHLORIDE
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 HYDROCHLORIDE
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists

US Patents and Regulatory Information for OXYCODONE HYDROCHLORIDE

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 022272-006 Apr 5, 2010 RX Yes No   Start Trial   Start Trial Y   Start Trial
Specgx Llc ROXICODONE oxycodone hydrochloride TABLET;ORAL 021011-001 Aug 31, 2000 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Purdue Pharma Lp OXYCONTIN oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022272-006 Apr 5, 2010 RX Yes No   Start Trial   Start Trial Y   Start Trial
Purdue Pharma Lp OXYCONTIN oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022272-003 Apr 5, 2010 RX Yes No   Start Trial   Start Trial Y   Start Trial
Mayne Pharma Inc OXYCODONE HYDROCHLORIDE oxycodone hydrochloride CAPSULE;ORAL 203107-001 Jul 26, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Purdue Pharma Lp OXYCONTIN oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022272-005 Apr 5, 2010 RX Yes Yes   Start Trial   Start Trial   Start Trial
Avanthi Inc OXYCODONE HYDROCHLORIDE oxycodone hydrochloride TABLET;ORAL 091393-004 Aug 31, 2009 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

Expired US Patents for OXYCODONE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Purdue Pharma Lp OXYCONTIN oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022272-002 Apr 5, 2010   Start Trial   Start Trial
Purdue Pharma Lp OXYCONTIN oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022272-001 Apr 5, 2010   Start Trial   Start Trial
Purdue Pharma Lp OXYCONTIN oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022272-005 Apr 5, 2010   Start Trial   Start Trial
Purdue Pharma Lp OXYCONTIN oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022272-007 Apr 5, 2010   Start Trial   Start Trial
Purdue Pharma Lp OXYCONTIN oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022272-003 Apr 5, 2010   Start Trial   Start Trial
Purdue Pharma Lp OXYCONTIN oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022272-007 Apr 5, 2010   Start Trial   Start Trial
Purdue Pharma Lp OXYCONTIN oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022272-002 Apr 5, 2010   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for OXYCODONE HYDROCHLORIDE

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:

AstraZeneca
Medtronic
McKinsey
Express Scripts
Moodys
Boehringer Ingelheim

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