Viewing data from:

ORFADIN

NDA

NITISINONE | N021232 | SWEDISH ORPHAN BIOVITRUM AB PUBL

4 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 Orfadin (2023)

Total Spending

$317K

Total Claims

Beneficiaries

—

Avg Cost/Unit

$203.21

Spending Trend

$114K(2019)→$112K(2020)→$334K(2021)→$416K(2022)→$317K(2023)

YoY Change:+15.1%

5yr CAGR:+17.4%

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

API Supply Chain4 active DMFs1 inactive

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

NOVITIUM PHARMA LLCNITISINONE

DMF 312502017

BIOPHORE INDIA PHARMACEUTICALS PVT LTDNITISINONE

DMF 339482019

SCL LIFESCIENCES LTDNITISINONE

DMF 358102021

DIPHARMA SANITISINONE

DMF 360262021

ZYDUS LIFESCIENCES LTDInactiveNITISINONE

DMF 306802016

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

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
May 20, 2019	SUPPL -23	View Letter (PDF)
Sep 6, 2017	SUPPL -20	View Letter (PDF)
May 22, 2014	SUPPL -13	View Letter (PDF)
Feb 15, 2013	SUPPL -10	View Letter (PDF)
Feb 5, 2010	SUPPL -8	View Letter (PDF)
Jan 18, 2002	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 2MG

RLDAB

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Jan 18, 2002

No patent or exclusivity listings for this strength.

#002 — 5MG

RLDAB

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Jan 18, 2002

#003 — 10MG

RLDAB

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Jan 18, 2002

#004 — 20MG

RLDAB

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Jun 13, 2016