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Last Updated: November 30, 2022

Oxycodone hydrochloride - Generic Drug Details


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What are the generic 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, 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-three 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
Wake Forest University Health SciencesPhase 2/Phase 3
Al-Azhar UniversityPhase 4

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
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
Ani Pharms OXYCODONE HYDROCHLORIDE oxycodone hydrochloride SOLUTION;ORAL 203447-001 Aug 30, 2017 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Purdue Pharma Lp OXYCONTIN oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022272-001 Apr 5, 2010 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 022272-001 Apr 5, 2010 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
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
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
Purdue Pharma Lp OXYCONTIN oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022272-006 Apr 5, 2010 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Roxane ROXICODONE oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 020932-001 Oct 26, 1998 DISCN No No See Plans and Pricing See Plans and Pricing 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 022272-007 Apr 5, 2010 See Plans and Pricing See Plans and Pricing
Purdue Pharma Lp OXYCONTIN oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022272-005 Apr 5, 2010 See Plans and Pricing See Plans and Pricing
Purdue Pharma Lp OXYCONTIN oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022272-001 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
Purdue Pharma Lp OXYCONTIN oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022272-005 Apr 5, 2010 See Plans and Pricing See Plans and Pricing
Purdue Pharma Lp OXYCONTIN oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022272-004 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
Poland 2305683 See Plans and Pricing
Australia 2004264667 Form of administration secured against misuse See Plans and Pricing
Dominican Republic P2009000026 FORMAS DE DOSIFICACION FARMACEUTICA ORAL RESISTENTE A LA MANIPULACION QUE COMPRENDE UN ANALGESICO OPIOIDE See Plans and Pricing
Croatia P20130433 See Plans and Pricing
China 1917862 Dosage form that is safeguarded from abuse See Plans and Pricing
Cyprus 1119598 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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Moodys

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