Viewing data from:

ROXICODONE

NDA

OXYCODONE HYDROCHLORIDE | N020932 | ROXANE LABORATORIES INC

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Purdue Pharma LP FDA-1999-P-2921 Purdue Pharma LP filed this citizen petition under Section 505 of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare the October 26, 1998 approval of Roxane Laboratories' NDA 20-932 for Roxicodone (oxycodone HCl) Sustained Release Tablets null and void, arguing that the applica	505(q)	2008-07-02	Granted	Purdue Pharma LP

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

3 trials from ClinicalTrials.gov — 1 recruiting, 2 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Pilot Randomized Control Trial Comparing Oral Ketamine and Oral Oxycodone for Pain Control in Emergency Department Patients NCT07670507	Phase 2/3	Not Yet Recruiting	Albany Medical College	60	2026-06-24 → 2027-04-30
Preeclampsia And Nonsteroidal Drugs for Analgesia: a Randomized Non Inferiority Trial NCT03978767	Phase 2	Completed	Washington University School of Medicine	287	2019-06-10 → 2026-06-15
Neurobehavioral Mechanisms of Choice in Opioid Use Disorder NCT03958474	Early Phase 1	Completed	Joshua A. Lile, Ph.D.	12	2019-08-16 → 2025-07-10

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Medicare Part D Spending

CMS annual spending data for Roxicodone (2023)

Total Spending

$2.0M

Total Claims

1,713

Beneficiaries

237

Avg Cost/Unit

$8.61

Spending Trend

$2.6M(2019)→$3.0M(2020)→$2.5M(2021)→$2.0M(2022)→$2.0M(2023)

YoY Change:-4.6%

5yr CAGR:+1.9%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain5 active DMFs6 inactive

4 active API suppliers hold Drug Master Files for this ingredient.

SPECGX LLCOXYCODONE HYDROCHLORIDE USP (D)

DMF 69301987

NORAMCO LLCOXYCODONE HYDROCHLORIDE

DMF 163992003

VERANOVA LPOXYCODONE HYDROCHLORIDE

DMF 184722005

NORAMCO LLCOXYCODONE HYDROCHLORIDE DRUG SUBSTANCE

DMF 209752007

SIEGFRIED USA LLCOXYCODONE HYDROCHLORIDE USP

DMF 235202010

MALLINCKRODT CHEMICAL INCInactiveOXYCODONE HYDROCHLORIDE PURIFIED RECRYSTALLIZED

DMF 28211977

NORAMCO INCInactiveOXYCODONE HYDROCHLORIDE

DMF 63181986

PENICK CORPInactiveOXYCODONE HYDROCHLORIDE

DMF 67681987

SIEGFRIED USA INCInactiveOXYCODONE HYDROCHLORIDE USP

DMF 193962006

JOHNSON MATTHEY PHARMACEUTICAL MATERIALSInactiveOXYCODONE HYDROCHLORIDE (MS PROCESS)

DMF 207292007

NORAMCO LLCInactiveOXYCODONE HYDROCHLORIDE USP (PROCESS II)

DMF 313772018

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Oct 26, 1998	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 10MG

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Oct 26, 1998

No patent or exclusivity listings for this strength.

#002 — 30MG

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Oct 26, 1998