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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 021232

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NDA 021232 describes ORFADIN, which is a drug marketed by Swedish Orphan and is included in two NDAs. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the ORFADIN profile page.

The generic ingredient in ORFADIN is nitisinone. There are two drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the nitisinone profile page.

Summary for 021232

Tradename:	ORFADIN
Applicant:	Swedish Orphan
Ingredient:	nitisinone
Patents:	0

Pharmacology for NDA: 021232

Mechanism of Action	Cytochrome P450 2C9 Inhibitors Cytochrome P450 2E1 Inducers Hydroxyphenylpyruvate Dioxygenase Inhibitors Organic Anion Transporter 1 Inhibitors Organic Anion Transporter 3 Inhibitors

Suppliers and Packaging for NDA: 021232

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ORFADIN	nitisinone	CAPSULE;ORAL	021232	NDA	SWEDISH ORPHAN BIOVITRUM AB (PUBL)	66658-102	66658-102-60	1 BOTTLE, PLASTIC in 1 CARTON (66658-102-60) / 60 CAPSULE in 1 BOTTLE, PLASTIC
ORFADIN	nitisinone	CAPSULE;ORAL	021232	NDA	SWEDISH ORPHAN BIOVITRUM AB (PUBL)	66658-105	66658-105-60	1 BOTTLE, PLASTIC in 1 CARTON (66658-105-60) / 60 CAPSULE in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	2MG
Approval Date:	Jan 18, 2002	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	5MG
Approval Date:	Jan 18, 2002	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	10MG
Approval Date:	Jan 18, 2002	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021232

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Swedish Orphan	ORFADIN	nitisinone	CAPSULE;ORAL	021232-001	Jan 18, 2002	⤷ Get Started Free	⤷ Get Started Free
Swedish Orphan	ORFADIN	nitisinone	CAPSULE;ORAL	021232-003	Jan 18, 2002	⤷ Get Started Free	⤷ Get Started Free
Swedish Orphan	ORFADIN	nitisinone	CAPSULE;ORAL	021232-002	Jan 18, 2002	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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