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Last Updated: March 28, 2024

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, Dr Reddys Labs Sa, Genus Lifesciences, Lannett Co Inc, Novel Labs Inc, Abhai Llc, Alkem Labs Ltd, Ascent Pharms Inc, Aurolife Pharma Llc, Chartwell Molecular, Hikma, Pharm Assoc, Pharmobedient Cnsltg, Quagen, Rhodes Pharms, Specgx Llc, Vistapharm, Wes Pharma Inc, 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 thirty-two 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

See drug prices for oxycodone

Drug Sales Revenue Trends for oxycodone

See drug sales revenues for oxycodone

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for oxycodone
Generic Entry Date for oxycodone*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE, EXTENDED RELEASE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for oxycodone

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

SponsorPhase
Washington State UniversityEarly Phase 1
National Center for Complementary and Integrative Health (NCCIH)Early Phase 1
University of MiamiPhase 2

See all oxycodone clinical trials

Generic filers with tentative approvals for OXYCODONE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial80MGTABLET, EXTENDED RELEASE; ORAL
⤷  Try a Trial⤷  Try a Trial80MGTABLET, EXTENDED RELEASE; ORAL
⤷  Try a Trial⤷  Try a 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 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
Vistapharm OXYCODONE HYDROCHLORIDE oxycodone hydrochloride SOLUTION;ORAL 202537-001 Jul 30, 2012 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Aurolife Pharma Llc OXYCODONE HYDROCHLORIDE oxycodone hydrochloride TABLET;ORAL 202160-001 Nov 19, 2012 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Collegium Pharm Inc XTAMPZA ER oxycodone CAPSULE, EXTENDED RELEASE;ORAL 208090-003 Apr 26, 2016 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Purdue Pharma Lp OXYCONTIN oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022272-007 Apr 5, 2010 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Hikma OXYCODONE HYDROCHLORIDE oxycodone hydrochloride SOLUTION;ORAL 208817-001 Aug 10, 2017 AA RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Amneal Pharms OXYCODONE HYDROCHLORIDE oxycodone hydrochloride TABLET;ORAL 203638-004 Jun 3, 2014 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Collegium Pharm Inc XTAMPZA ER oxycodone CAPSULE, EXTENDED RELEASE;ORAL 208090-005 Apr 26, 2016 ⤷  Try a Trial ⤷  Try a Trial
Collegium Pharm Inc XTAMPZA ER oxycodone CAPSULE, EXTENDED RELEASE;ORAL 208090-002 Apr 26, 2016 ⤷  Try a Trial ⤷  Try a Trial
Collegium Pharm Inc XTAMPZA ER oxycodone CAPSULE, EXTENDED RELEASE;ORAL 208090-005 Apr 26, 2016 ⤷  Try a Trial ⤷  Try a Trial
Collegium Pharm Inc XTAMPZA ER oxycodone CAPSULE, EXTENDED RELEASE;ORAL 208090-005 Apr 26, 2016 ⤷  Try a Trial ⤷  Try a Trial
Collegium Pharm Inc XTAMPZA ER oxycodone CAPSULE, EXTENDED RELEASE;ORAL 208090-001 Apr 26, 2016 ⤷  Try a Trial ⤷  Try a Trial
Collegium Pharm Inc XTAMPZA ER oxycodone CAPSULE, EXTENDED RELEASE;ORAL 208090-005 Apr 26, 2016 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for oxycodone

Country Patent Number Title Estimated Expiration
Slovenia 1765292 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2005123039 ⤷  Try a Trial
Japan 2015166402 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) ⤷  Try a Trial
Lithuania 1765292 ⤷  Try a Trial
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) ⤷  Try a Trial
Canada 2491572 COMPOSITIONS PHARMACEUTIQUES EMPECHANT LA CONSOMMATION ABUSIVE D'OPIOIDES ET D'AUTRES DROGUES (ABUSE-DETERRENT PHARMACEUTICAL COMPOSITIONS OF OPIODS AND OTHER DRUGS) ⤷  Try a Trial
>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 ⤷  Try a 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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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.