ORFADIN Drug Patent Profile

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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.

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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:	499
Drug Prices:	Drug price information for ORFADIN
What excipients (inactive ingredients) are in ORFADIN?	ORFADIN excipients list
DailyMed Link:	ORFADIN at DailyMed

Drug patent expirations by year for ORFADIN

Recent Clinical Trials for ORFADIN

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

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

US Patents and Regulatory Information for ORFADIN

ORFADIN is protected by one US patents.

Patents protecting ORFADIN

Liquid pharmaceutical composition comprising nitisinone
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF HEREDITARY TYROSINEMIA TYPE 1 (HT-1) IN COMBINATION WITH DIETARY RESTRICTION OF TYROSINE AND PHENYLALANINE

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Glossary

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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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Swedish Orphan	ORFADIN	nitisinone	CAPSULE;ORAL	021232-004	Jun 13, 2016	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Swedish Orphan	ORFADIN	nitisinone	CAPSULE;ORAL	021232-002	Jan 18, 2002	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for ORFADIN

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

EU/EMA Drug Approvals for ORFADIN

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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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

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

Patent: 12273515
Patent: Liquid pharmaceutical composition comprising nitisinone
Estimated Expiration: ⤷ Sign Up

Brazil

Patent: 2013033008
Estimated Expiration: ⤷ Sign Up

Canada

Patent: 38039
Patent: COMPOSITION PHARMACEUTIQUE LIQUIDE COMPRENANT DE LA NITISINONE (LIQUID PHARMACEUTICAL COMPOSITION COMPRISING NITISINONE)
Estimated Expiration: ⤷ Sign Up

Chile

Patent: 13003630
Patent: Formulacion farmaceutica liquida que comprende nitisinona y un tampon de acido citrico que tien un ph en el rango de 2,5 a 3,5, de preferencia 3,0; y su uso para el tratamiento de tirosemia, enfermedad de parkinson, depresion, entre otros.
Estimated Expiration: ⤷ Sign Up

China

Patent: 3747781
Patent: Liquid pharmaceutical composition comprising nitisinone
Estimated Expiration: ⤷ Sign Up

Croatia

Patent: 0160286
Estimated Expiration: ⤷ Sign Up

Cyprus

Patent: 17273
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Denmark

Patent: 23320
Estimated Expiration: ⤷ Sign Up

European Patent Office

Patent: 23320
Patent: COMPOSITION PHARMACEUTIQUE LIQUIDE COMPRENANT DE LA NITISINONE (LIQUID PHARMACEUTICAL COMPOSITION COMPRISING NITISINONE)
Estimated Expiration: ⤷ Sign Up

Hungary

Patent: 27304
Estimated Expiration: ⤷ Sign Up

Israel

Patent: 9677
Patent: פורמולציה נוזלית המתאימה למתן דרך הפה המכילה תרחיף של גבישים זעירים של 2 (2-ניטרו-טריפלואורומתילבנזויל)- 1,3 -ציקלוהקסאנדיאון ובופר חומצה ציטרית (Liquid formulation suitable for oral administration comprising a suspension of micronized 2(2-nitro-4-trifluoromethylbenzoyl)-1,3-cyclohexandione and citric acid buffer)
Estimated Expiration: ⤷ Sign Up

Japan

Patent: 38132
Estimated Expiration: ⤷ Sign Up

Patent: 14517067
Estimated Expiration: ⤷ Sign Up

Mexico

Patent: 13014567
Patent: COMPOSICION FARMACEUTICA LIQUIDA QUE COMPRENDE NITISINONA. (LIQUID PHARMACEUTICAL COMPOSITION COMPRISING NITISINONE.)
Estimated Expiration: ⤷ Sign Up

New Zealand

Patent: 8332
Patent: Liquid pharmaceutical composition comprising nitisinone
Estimated Expiration: ⤷ Sign Up

Poland

Patent: 23320
Estimated Expiration: ⤷ Sign Up

Russian Federation

Patent: 05301
Patent: ЖИДКАЯ ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, ВКЛЮЧАЮЩАЯ НИТИЗИНОН (LIQUID PHARMACEUTICAL COMPOSITION CONTAINING NITIZINONE)
Estimated Expiration: ⤷ Sign Up

Patent: 14101990
Patent: ЖИДКАЯ ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, ВКЛЮЧАЮЩАЯ НИТИЗИНОН
Estimated Expiration: ⤷ Sign Up

San Marino

Patent: 01600097
Patent: COMPOSIZIONE FARMACEUTICA LIQUIDA CHE COMPRENDE NITISONE
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Serbia

Patent: 632
Patent: TEČNA FARMACEUTSKA KOMPOZICIJA KOJA SADRŽI NITIZINON (LIQUID PHARMACEUTICAL COMPOSITION COMPRISING NITISINONE)
Estimated Expiration: ⤷ Sign Up

Slovenia

Patent: 23320
Estimated Expiration: ⤷ Sign Up

Spain

Patent: 66787
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Ukraine

Patent: 0979
Patent: РІДКА ФАРМАЦЕВТИЧНА КОМПОЗИЦІЯ, ЯКА ВКЛЮЧАЄ НІТИЗИНОН (LIQUID PHARMACEUTICAL FORMULATION COMPRISING NITISINONE)
Estimated Expiration: ⤷ Sign Up

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.

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Country	Patent Number	Title	Estimated Expiration
China	103747781	Liquid pharmaceutical composition comprising nitisinone	⤷ Sign Up
German Democratic Republic	232416	HERBIZIDE MITTEL	⤷ Sign Up
Japan	H06508628		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for ORFADIN

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0137963	97C0042	Belgium	⤷ Sign Up	PRODUCT NAME: 2-(2-BENZOYL-SUBSTITUE)-1,3-CYCLOHEXANE-DIONES; REGISTRATION NO/DATE: 8452/B 19930121
0591275	SPC/GB05/030	United Kingdom	⤷ Sign Up	PRODUCT NAME: NITISINONE (2-(2-NITRO-4-TRIFLUOROMETHYLBENZOYL)-1,3-CYCLOHEXANEDIONE) OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/04/303/001 20050221; UK EU/1/04/303/002 20050221; UK EU/1/04/303/003 20050221
0186118	C350003	Netherlands	⤷ Sign Up	PRODUCT NAME: MESOTRIONE, DESGEWENST IN DE VORM VAN EEN ZOUT; REGISTRATION NO/DATE: 12204N 20010504
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Summary for ORFADIN

Recent Clinical Trials for ORFADIN

Pharmacology for ORFADIN

Patents protecting ORFADIN

When does loss-of-exclusivity occur for ORFADIN?

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