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Oxycodoneis the generic ingredient in six branded drugs marketed by Collegium Pharm Inc, Ani Pharms Inc, Avanthi Inc, Genus Lifesciences, Lannett Co Inc, Mayne Pharma Inc, Novel Labs Inc, Abhai Llc, Alkem Labs Ltd, Ascent Pharms Inc, Aurolife Pharma Llc, Eywa, Hi Tech, Hikma, Pharm Assoc, 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, Sun Pharm Inds Inc, Vintage Pharms, and Ohemo Life, and is included in fifty-two NDAs. There are fifty 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.
Summary for oxycodone
|Drug Master File Entries:||19|
|Suppliers / Packagers:||1|
|Bulk Api Vendors:||19|
|Formulation / Manufacturing:||see details|
|Drug Prices:||Drug price trends for oxycodone|
|Drug Sales Revenues:||Drug sales revenues for oxycodone|
|Patent Litigation and PTAB cases:||See patent lawsuits and PTAB cases for oxycodone|
|DailyMed Link:||oxycodone at DailyMed|
Recent Clinical Trials for oxycodone
Identify potential brand extensions & 505(b)(2) entrants
|Washington University School of Medicine||N/A|
|NYU Langone Health||Phase 4|
|Clinilabs, Inc.||Phase 1/Phase 2|
Generic filers with tentative approvals for OXYCODONE
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 Class||Opioid Agonist |
|Mechanism of Action||Full Opioid Agonists |
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||TE||Type||RLD||RS||Patent No.||Patent Expiration||Product||Substance||Delist Req.||Exclusivity Expiration|
|Collegium Pharm Inc||XTAMPZA ER||oxycodone||CAPSULE, EXTENDED RELEASE;ORAL||208090-002||Apr 26, 2016||RX||Yes||No||Start Trial||Start Trial||Y||Start Trial|
|Hikma||OXYCODONE HYDROCHLORIDE||oxycodone hydrochloride||SOLUTION;ORAL||203208-001||Jul 12, 2013||DISCN||No||No||Start Trial||Start Trial||Start Trial|
|Purdue Pharma Lp||OXYCONTIN||oxycodone hydrochloride||TABLET, EXTENDED RELEASE;ORAL||022272-007||Apr 5, 2010||RX||Yes||No||Start Trial||Start Trial||Start Trial|
|>Applicant||>Tradename||>Generic Name||>Dosage||>NDA||>Approval Date||>TE||>Type||>RLD||>RS||>Patent No.||>Patent Expiration||>Product||>Substance||>Delist Req.||>Exclusivity Expiration|
|Patent Number||Supplementary Protection Certificate||SPC Country||SPC Expiration||SPC Description|
|1685839||92292||Luxembourg||Start 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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