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NORFLEX

NDA

ORPHENADRINE CITRATE | N012157 | BAUSCH HEALTH US LLC

1 strength0 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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Orphenadrine Citrate ER (2023)

Total Spending

$1.9M

Total Claims

49,274

Beneficiaries

25,044

Avg Cost/Unit

$0.82

Spending Trend

$1.9M(2019)→$1.8M(2020)→$1.7M(2021)→$1.8M(2022)→$1.9M(2023)

YoY Change:+3.4%

5yr CAGR:+9.3%

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

API Supply Chain4 active DMFs3 inactive

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

W R GRACE AND CO -CONNORPHENADRINE CITRATE USP

DMF 57221985

PROCOS SPAORPHENADRINE CITRATE

DMF 149712000

R L FINE CHEM PVT LTDORPHENADRINE CITRATE

DMF 339012019

R L FINE CHEM PVT LTDORPHENADRINE CITRATE

DMF 384562023

ORGAMOL SAInactiveORPHENADRINE CITRATE AND ORPHENADRINE HCL.

DMF 48111983

3M PHARMACEUTICALSInactiveORPHENADRINE CITRATE

DMF 71081987

IROPHARM LTDInactiveORPHENADRINE CITRATE

DMF 78371988

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Apr 9, 2007	SUPPL -28	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.