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Last Updated: July 2, 2020

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ROXICODONE Drug Profile


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When do Roxicodone patents expire, and what generic alternatives are available?

Roxicodone is a drug marketed by Roxane and Specgx Llc and is included in two NDAs.

The generic ingredient in ROXICODONE is oxycodone hydrochloride. There are nineteen drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the oxycodone hydrochloride profile page.

US ANDA Litigation and Generic Entry Outlook for Roxicodone

A generic version of ROXICODONE was approved as oxycodone hydrochloride by ACTAVIS ELIZABETH on February 6th, 2004.

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Drug patent expirations by year for ROXICODONE
Drug Prices for ROXICODONE

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Recent Clinical Trials for ROXICODONE

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SponsorPhase
University of North Carolina, Chapel HillPhase 4
Society of Family PlanningPhase 4
Johns Hopkins UniversityPhase 4

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Pharmacology for ROXICODONE
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists

US Patents and Regulatory Information for ROXICODONE

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 020932-001 Oct 26, 1998 DISCN No No   Start Trial   Start Trial   Start Trial
Specgx Llc ROXICODONE oxycodone hydrochloride TABLET;ORAL 021011-001 Aug 31, 2000 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Roxane ROXICODONE oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 020932-002 Oct 26, 1998 DISCN No 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

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Boehringer Ingelheim
Johnson and Johnson
Mallinckrodt
Colorcon
Moodys

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