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Last Updated: March 28, 2024

Oxycodone hydrochloride - Generic Drug Details


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

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

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

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

Recent Clinical Trials for oxycodone hydrochloride

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 hydrochloride clinical trials

Generic filers with tentative approvals for OXYCODONE HYDROCHLORIDE
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 hydrochloride
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
Paragraph IV (Patent) Challenges for OXYCODONE HYDROCHLORIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
OXAYDO Tablets oxycodone hydrochloride 5 mg and 7.5 mg 202080 1 2012-02-07
OXYCONTIN Extended-release Tablets oxycodone hydrochloride 20 mg 022272 2 2010-10-29
OXYCONTIN Extended-release Tablets oxycodone hydrochloride 15 mg 022272 1 2010-10-28
OXYCONTIN Extended-release Tablets oxycodone hydrochloride 10 mg 022272 1 2010-10-25
OXYCONTIN Extended-release Tablets oxycodone hydrochloride 30 mg, 60 mg and 80 mg 022272 1 2010-10-18
OXYCONTIN Extended-release Tablets oxycodone hydrochloride 40 mg 022272 1 2010-10-04

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 022272-004 Apr 5, 2010 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Protega Pharms ROXYBOND oxycodone hydrochloride TABLET;ORAL 209777-001 Apr 20, 2017 RX No No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Quagen OXYCODONE HYDROCHLORIDE oxycodone hydrochloride SOLUTION;ORAL 213761-002 Jun 2, 2021 AA RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Nuvo Pharm OXYCODONE HYDROCHLORIDE oxycodone hydrochloride TABLET;ORAL 207119-004 Apr 12, 2016 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Purdue Pharma Lp OXYCONTIN oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022272-003 Apr 5, 2010 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Specgx Llc ROXICODONE oxycodone hydrochloride TABLET;ORAL 021011-003 May 15, 2009 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Epic Pharma Llc OXYCODONE HYDROCHLORIDE oxycodone hydrochloride TABLET;ORAL 202662-004 Sep 22, 2015 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 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 ⤷  Try a Trial ⤷  Try a Trial
Purdue Pharma Lp OXYCONTIN oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022272-006 Apr 5, 2010 ⤷  Try a Trial ⤷  Try a Trial
Purdue Pharma Lp OXYCONTIN oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022272-007 Apr 5, 2010 ⤷  Try a Trial ⤷  Try a Trial
Purdue Pharma Lp OXYCONTIN oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022272-002 Apr 5, 2010 ⤷  Try a Trial ⤷  Try a Trial
Purdue Pharma Lp OXYCONTIN oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022272-006 Apr 5, 2010 ⤷  Try a Trial ⤷  Try a Trial
Purdue Pharma Lp OXYCONTIN oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022272-003 Apr 5, 2010 ⤷  Try a Trial ⤷  Try a Trial
Purdue Pharma Lp OXYCONTIN oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022272-002 Apr 5, 2010 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for oxycodone hydrochloride

Country Patent Number Title Estimated Expiration
European Patent Office 1730151 PROCEDE DE PREPARATION D'HYDROCHLORURE D'OXYCODONE PRESENTANT MOINS DE 25 PPM DE 14-HYDROXYCODEINONE (PROCESS FOR PREPARING OXYCODONE HYDROCHLORIDE HAVING LESS THAN 25 PPM 14-HYDROXYCODEINONE) ⤷  Try a Trial
Taiwan 200824722 Pharmaceutical dosage forms ⤷  Try a Trial
Montenegro 01255 FARMACEUTSKI DOZNI OBLICI REZISTENTNI NA ZLOUPOTREBU KOJI SADRŽE OPIOIDNI ANALGETIK (TAMPER RESISTANT ORAL PHARMACEUTICAL DOSAGE FORMS COMPRISING AN OPIOID ANALGESIC) ⤷  Try a Trial
Mexico 336789 FARMACOS RESISTENTES AL ABUSO, METODO DE USO Y METODO DE FABRICACION. (ABUSE RESISTANT DRUGS, METHOD OF USE AND METHOD OF MAKING.) ⤷  Try a Trial
Serbia 54598 POSTUPAK ZA DOBIJANJE KOMPOZICIJA OKSIKODON HIDROHLORIDA SA MANJE OD 25ppm 14-HIDROKSIKODEINONA (PROCESS FOR PREPARING OXYCODONE HYDROCHLORIDE COMPOSITIONS HAVING LESS THAN 25PPM 14-HYDROXYCODEINONE) ⤷  Try a Trial
Denmark 1897545 ⤷  Try a Trial
Germany 202005021371 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for oxycodone hydrochloride

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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