You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: April 13, 2024

Oxycodone hydrochloride - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


What are the generic 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, 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
Anatomical Therapeutic Chemical (ATC) Classes for oxycodone hydrochloride
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
Roxane ROXICODONE oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 020932-002 Oct 26, 1998 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Purdue Pharma Lp OXYCONTIN oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022272-006 Apr 5, 2010 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  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
Protega Pharms ROXYBOND oxycodone hydrochloride TABLET;ORAL 209777-003 Apr 20, 2017 RX No No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  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 022272-001 Apr 5, 2010 ⤷  Try a Trial ⤷  Try a Trial
Purdue Pharma Lp OXYCONTIN oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022272-004 Apr 5, 2010 ⤷  Try a Trial ⤷  Try a Trial
Purdue Pharma Lp OXYCONTIN oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022272-001 Apr 5, 2010 ⤷  Try a Trial ⤷  Try a Trial
Purdue Pharma Lp OXYCONTIN oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022272-005 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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for oxycodone hydrochloride

Country Patent Number Title Estimated Expiration
Japan 5118223 ⤷  Try a Trial
Hong Kong 1155728 含有少於 -羥可待因酮的鹽酸羥可待酮的藥物劑型 (PHARMACEUTICAL DOSAGE FORM COMPRISING OXYCODONE HYDROCHLORIDE HAVING LESS THAN 25 PPM 14-HYDROXYCODEINONE 25PPM 14-) ⤷  Try a Trial
China 102743355 Tamper resistant oral pharmaceutical dosage forms comprising an opioid analgesic ⤷  Try a Trial
Dominican Republic P2009000026 FORMAS DE DOSIFICACION FARMACEUTICA ORAL RESISTENTE A LA MANIPULACION QUE COMPRENDE UN ANALGESICO OPIOIDE ⤷  Try a Trial
Slovenia 2384754 ⤷  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

Make Better Decisions: Try a trial or see plans & pricing

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.