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Last Updated: August 11, 2022

Oxycodone hydrochloride - Generic Drug Details


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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, 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-two NDAs. There are twenty-nine 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 patent family members in forty-nine countries.

There are twelve drug master file entries for oxycodone hydrochloride. Forty-five 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
Eurofarma Laboratorios S.A.Phase 3
Yale UniversityPhase 1
Bhupesh Parashar, MDPhase 2

See all oxycodone hydrochloride clinical trials

Generic filers with tentative approvals for OXYCODONE HYDROCHLORIDE
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 hydrochloride
Drug Class Opioid 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
Mayne Pharma Inc OXYCODONE HYDROCHLORIDE oxycodone hydrochloride CAPSULE;ORAL 203107-001 Jul 26, 2012 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Specgx Llc ROXICODONE oxycodone hydrochloride TABLET;ORAL 021011-001 Aug 31, 2000 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Zyla OXAYDO oxycodone hydrochloride TABLET;ORAL 202080-002 Jun 17, 2011 RX Yes No 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

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 022272-003 Apr 5, 2010 See Plans and Pricing See Plans and Pricing
Purdue Pharma Lp OXYCONTIN oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022272-002 Apr 5, 2010 See Plans and Pricing See Plans and Pricing
Purdue Pharma Lp OXYCONTIN oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022272-006 Apr 5, 2010 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for oxycodone hydrochloride

Country Patent Number Title Estimated Expiration
Singapore 170736 PROCESS FOR PREPARING OXYCODONE HYDROCHLORIDE HAVING LESS THAN 25 PPM 14- HYDROXYCODEINONE See Plans and Pricing
Hong Kong 1138498 TAMPER RESISTANT ORAL PHARMACEUTICAL DOSAGE FORMS COMPRISING AN OPIOID ANALGESIC See Plans and Pricing
Peru 20091184 FORMAS DE DOSIFICACION FARMACEUTICA See Plans and Pricing
>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 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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Serving leading biopharmaceutical companies globally:

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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.