ORFADIN Drug Patent Profile

Which patents cover Orfadin, and what generic alternatives are available?

Orfadin is a drug marketed by Swedish Orphan and is included in two NDAs. There is one patent protecting this drug.

This drug has twenty-four patent family members in twenty-two countries.

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.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Orfadin

A generic version of ORFADIN was approved as nitisinone by NOVITIUM PHARMA on August 26^th, 2019.

Summary for ORFADIN

International Patents:	24
US Patents:	1
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	125
Clinical Trials:	12
Patent Applications:	565
Drug Prices:	Drug price information for ORFADIN
What excipients (inactive ingredients) are in ORFADIN?	ORFADIN excipients list
DailyMed Link:	ORFADIN at DailyMed

See drug prices for ORFADIN

Recent Clinical Trials for ORFADIN

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Sutphin Drugs	N/A
Cycle Pharmaceuticals Ltd.	Phase 1
Parexel	Phase 1

See all ORFADIN clinical trials

Pharmacology for ORFADIN

Drug Class	4-Hydroxyphenyl-Pyruvate Dioxygenase Inhibitor
Mechanism of Action	Cytochrome P450 2C9 Inhibitors Cytochrome P450 2E1 Inducers Hydroxyphenylpyruvate Dioxygenase Inhibitors Organic Anion Transporter 1 Inhibitors Organic Anion Transporter 3 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ORFADIN

A16AX	Various alimentary tract and metabolism products
A16A	OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
A16	OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
A	Alimentary tract and metabolism

US Patents and Regulatory Information for ORFADIN

ORFADIN is protected by one US patents.

Patents protecting ORFADIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Swedish Orphan	ORFADIN	nitisinone	CAPSULE;ORAL	021232-001	Jan 18, 2002	AB	RX	Yes	No
Swedish Orphan	ORFADIN	nitisinone	CAPSULE;ORAL	021232-004	Jun 13, 2016	AB	RX	Yes	Yes
Swedish Orphan	ORFADIN	nitisinone	CAPSULE;ORAL	021232-002	Jan 18, 2002	AB	RX	Yes	No
Swedish Orphan	ORFADIN	nitisinone	CAPSULE;ORAL	021232-003	Jan 18, 2002	AB	RX	Yes	No
Swedish Orphan	ORFADIN	nitisinone	SUSPENSION;ORAL	206356-001	Apr 22, 2016		RX	Yes	Yes			Y

Expired US Patents for ORFADIN

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

EU/EMA Drug Approvals for ORFADIN

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
MendeliKABS Europe Ltd	Nitisinone MDK (previously Nitisinone MendeliKABS)	nitisinone	EMEA/H/C/004281 Treatment of adult and paediatric (in any age range) patients with confirmed diagnosis of hereditary tyrosinemia type 1 (HT 1) in combination with dietary restriction of tyrosine and phenylalanine.	Withdrawn	yes	no	no	2017-08-24
Cycle Pharmaceuticals (Europe) Ltd	Nityr	nitisinone	EMEA/H/C/004582 Treatment of adult and paediatric patients with confirmed diagnosis of hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine.	Authorised	yes	no	no	2018-07-26
Swedish Orphan Biovitrum International AB	Orfadin	nitisinone	EMEA/H/C/000555 Hereditary tyrosinemia type 1 (HT 1)Orfadin is indicated for the treatment of adult and paediatric (in any age range) patients with confirmed diagnosis of hereditary tyrosinemia type 1 (HT 1) in combination with dietary restriction of tyrosine and phenylalanine.Alkaptonuria (AKU)Orfadin is indicated for the treatment of adult patients with alkaptonuria (AKU).	Authorised	no	no	no	2005-02-21

International Patents for ORFADIN

When does loss-of-exclusivity occur for ORFADIN?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

Chile

China

Croatia

Cyprus

Denmark

European Patent Office

Hungary

Israel

Japan

Mexico

New Zealand

Poland

Russian Federation

San Marino

Serbia

Slovenia

Spain

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ORFADIN around the world.

Country	Patent Number	Title	Estimated Expiration
South Korea	890000193
New Zealand	214631	2-(2'-NITROBENZOYL)-1,3-CYCLOHEXANEDIONE DERIVATIVES AND HERBICIDES
Germany	3773768
Israel	72633
United Kingdom	9113622
Australia	585917
Bulgaria	38931	HERBICIDE MEANS AND METHOD FOR CONTROL OF UNWANTED VEGETATION

Supplementary Protection Certificates for ORFADIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0591275	91180	Luxembourg		91180, EXPIRES: 20170618
0591275	24/2005	Austria		PRODUCT NAME: NITISINON ODER EIN PHARMAZEUTISCH ZULAESSIGES SALZ HIERVON; REGISTRATION NO/DATE: EU/1/04/303/001- EU/1/04/303/003 20050221
0591275	CA 2005 00029	Denmark
0591275	C300198	Netherlands		PRODUCT NAME: NITISINONE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAAR DBAAR ZOUT; REGISTRATION NO/DATE: EU/1/04/303/001-003 20050201
0186118	C350003	Netherlands		PRODUCT NAME: MESOTRIONE, DESGEWENST IN DE VORM VAN EEN ZOUT; REGISTRATION NO/DATE: 12204N 20010504
0186118	SPC/GB05/029	United Kingdom		PRODUCT NAME: MESOTRIONE (2-(4-METHYLSULPHONYL-2-NITROBENZOYL)-1,3CYCLOHEXANEDIONE); REGISTERED: AU 2726 20001016; UK 0309 OF 2005 20050218
0186118	SPC/GB05/037	United Kingdom		PRODUCT NAME: A COMBINATION OF TERBUTHYLAZINE AND MESOTRIONE; REGISTERED: DK 1-186 20050203; UK 0805 OF 2005 20050425