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Last Updated: January 27, 2023

Oxycodone - Generic Drug Details


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What are the generic 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, 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, Chartwell Molecular, Eywa, Hikma, Pharm Assoc, Quagen, 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, Strides Pharma, Sun Pharm Inds Inc, and Protega Pharms, and is included in fifty-three NDAs. There are forty-eight 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
Eurofarma Laboratorios S.A.Phase 3
Wake Forest University Health SciencesPhase 2/Phase 3
Vestre VikenHF Kongsberg SykehusPhase 4

See all oxycodone clinical trials

Generic filers with tentative approvals for OXYCODONE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing80MGTABLET, EXTENDED RELEASE; ORAL
See Plans and PricingSee Plans and Pricing80MGTABLET, EXTENDED RELEASE; ORAL
See Plans and PricingSee Plans and Pricing40MGTABLET, 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 Class Opioid Agonist
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for oxycodone
Paragraph IV (Patent) Challenges for OXYCODONE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
XTAMPZA ER Extended-release Capsules oxycodone 9 mg, 13.5 mg, 18 mg, 27 mg and 36 mg 208090 1 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 022272-003 Apr 5, 2010 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sun Pharm Inds Inc OXYCODONE HYDROCHLORIDE oxycodone hydrochloride TABLET;ORAL 090659-004 Nov 6, 2012 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Collegium Pharm Inc XTAMPZA ER oxycodone CAPSULE, EXTENDED RELEASE;ORAL 208090-002 Apr 26, 2016 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Purdue Pharma Lp OXYCONTIN oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022272-007 Apr 5, 2010 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Purdue Pharma Lp OXYCONTIN oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022272-005 Apr 5, 2010 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Nuvo Pharm OXYCODONE HYDROCHLORIDE oxycodone hydrochloride TABLET;ORAL 207119-004 Apr 12, 2016 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Purdue Pharma Lp OXYCONTIN oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022272-005 Apr 5, 2010 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 Title Estimated Expiration
World Intellectual Property Organization (WIPO) 2004004693 See Plans and Pricing
European Patent Office 1765292 FORMULATIONS DE PRÉVENTION DES ABUS (ABUSE-DETERRENT DRUG FORMULATIONS) See Plans and Pricing
Poland 1765292 See Plans and Pricing
Spain 2653568 See Plans and Pricing
Japan 4694207 See Plans and Pricing
World Intellectual Property Organization (WIPO) 2017222575 See Plans and Pricing
Japan 2017101075 オピオイドおよび他の薬物に関する乱用抑止性の薬学的組成物 (ABUSE-DETERRENT PHARMACEUTICAL COMPOSITIONS OF OPIOIDS AND OTHER DRUGS) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for oxycodone

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1685839 92292 Luxembourg See Plans and Pricing 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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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 verification 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.