Viewing data from:

NORTHERA

NDA

DROXIDOPA | N203202 | LUNDBECK NA LTD

3 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

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 Northera (2023)

Total Spending

$27.9M

Total Claims

1,589

Beneficiaries

277

Avg Cost/Unit

$86.89

Spending Trend

$211.5M(2019)→$240.8M(2020)→$88.7M(2021)→$38.0M(2022)→$27.9M(2023)

YoY Change:+8.0%

5yr CAGR:+8.8%

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

API Supply Chain9 active DMFs1 inactive

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

MSN LIFE SCIENCES PRIVATE LTDDROXIDOPA

DMF 315142017

LUPIN MANUFACTURING SOLUTIONS LTDDROXIDOPA

DMF 320322017

DASAMI LAB PRIVATE LTDDROXIDOPA

DMF 321842017

QUIMICA SINTETICA SADROXIDOPA

DMF 322642017

MATRIX PHARMACORP PRIVATE LTDDROXIDOPA

DMF 330892018

CLAROCHEM IRELAND LTDDROXIDOPA

DMF 334592019

PIRAMAL PHARMA LTDDROXIDOPA

DMF 342582019

SUN PHARMACEUTICAL INDUSTRIES LTDDROXIDOPA

DMF 343892019

DASAMI LAB PRIVATE LTDDROXIDOPA (PROCESS-II)

DMF 353682020

SUMITOMO DAINIPPON PHARMA CO LTDInactiveDROXIDOPA

DMF 205562007

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Feb 13, 2017	SUPPL -7	View Letter (PDF)
Oct 5, 2016	SUPPL -6	View Letter (PDF)
Feb 19, 2014	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 100MG

RLDAB

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Feb 18, 2014

No patent or exclusivity listings for this strength.

#002 — 200MG

RLDAB

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Feb 18, 2014

#003 — 300MG

RLDAB

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Feb 18, 2014