Viewing data from:

ORFADIN

NDA

NITISINONE | N206356 | SWEDISH ORPHAN BIOVITRUM AB PUBL

1 strength1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Active (1)Today

2027

2028

2029

2030

2031

2032

2033

Today

9301932

Feb. 28, 2033

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

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

4 letters from Drugs@FDA

Date	Submission	Document
May 20, 2019	SUPPL -6	View Letter (PDF)
Sep 6, 2017	SUPPL -3	View Letter (PDF)
Aug 30, 2016	SUPPL -2	View Letter (PDF)
Apr 26, 2016	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 4MG/ML

RLD

1 patent0 exclusivities▴

SUSPENSION;ORAL | Approved: Apr 22, 2016

Patents (1)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9301932	Feb 28, 2033	—	—	Yes		—