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Oxycodone hydrochlorideis the generic ingredient in five branded drugs marketed by Ani Pharms Inc, 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, Eywa, 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-one NDAs. There are thirty-one patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.
Oxycodone hydrochloride has five hundred and ninety-eight patent family members in forty-eight countries.
There are nineteen drug master file entries for oxycodone hydrochloride. Forty-three suppliers are listed for this compound. There are four tentative approvals for this compound.
Summary for oxycodone hydrochloride
|Drug Master File Entries:||19|
|Finished Product Suppliers / Packagers:||43|
|Raw Ingredient (Bulk) Api Vendors:||20|
|Formulation / Manufacturing:||see details|
|Patent Litigation and PTAB cases:||See patent lawsuits and PTAB cases for oxycodone hydrochloride|
|What excipients (inactive ingredients) are in oxycodone hydrochloride?||oxycodone hydrochloride excipients list|
|DailyMed Link:||oxycodone hydrochloride at DailyMed|
Recent Clinical Trials for oxycodone hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
|Medical College of Wisconsin||Phase 2|
|Medlab Clinical||Phase 3|
|George Clinical Pty Ltd||Phase 3|
Generic filers with tentative approvals for OXYCODONE HYDROCHLORIDE
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 Action||Full Opioid Agonists |
ATC Classes for oxycodone hydrochloride
|Country||Patent Number||Estimated Expiration|
|Australia||2013202453||Try Before You Buy|
|Portugal||2080514||Try Before You Buy|
|European Patent Office||2187873||Try Before You Buy|
|Brazil||PI0413318||Try Before You Buy|
|Ecuador||SP066953||Try Before You Buy|
|Japan||5373133||Try Before You Buy|
|>Country||>Patent Number||>Estimated Expiration|
|Patent Number||Supplementary Protection Certificate||SPC Country||SPC Expiration||SPC Description|
|1685839||92292||Luxembourg||Try Before You Buy||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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