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Last Updated: May 26, 2022

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. Four 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 26th, 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: 110
Clinical Trials: 12
Patent Applications: 590
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
Drug Prices for ORFADIN

See drug prices for ORFADIN

Recent Clinical Trials for ORFADIN

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

SponsorPhase
Sutphin DrugsN/A
ParexelPhase 1
Cycle Pharmaceuticals Ltd.Phase 1

See all ORFADIN clinical trials

US Patents and Regulatory Information for ORFADIN

ORFADIN is protected by one US patents.

Patents protecting ORFADIN

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

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Swedish Orphan ORFADIN nitisinone CAPSULE;ORAL 021232-004 Jun 13, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Swedish Orphan ORFADIN nitisinone CAPSULE;ORAL 021232-002 Jan 18, 2002 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Swedish Orphan ORFADIN nitisinone CAPSULE;ORAL 021232-003 Jan 18, 2002 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Swedish Orphan ORFADIN nitisinone SUSPENSION;ORAL 206356-001 Apr 22, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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

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

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
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2013033008
Estimated Expiration: See Plans and Pricing

Canada

Patent: 38039
Estimated Expiration: See Plans and Pricing

Chile

Patent: 13003630
Estimated Expiration: See Plans and Pricing

China

Patent: 3747781
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0160286
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 17273
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 23320
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 23320
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 27304
Estimated Expiration: See Plans and Pricing

Israel

Patent: 9677
Estimated Expiration: See Plans and Pricing

Japan

Patent: 38132
Estimated Expiration: See Plans and Pricing

Patent: 14517067
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 13014567
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 8332
Estimated Expiration: See Plans and Pricing

Poland

Patent: 23320
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 05301
Estimated Expiration: See Plans and Pricing

Patent: 14101990
Estimated Expiration: See Plans and Pricing

San Marino

Patent: 01600097
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 632
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 23320
Estimated Expiration: See Plans and Pricing

Spain

Patent: 66787
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 0979
Estimated Expiration: See Plans and Pricing

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
Yugoslavia 201285 See Plans and Pricing
Bulgaria 43852 HERBICIDE MEANS AND METHOD FOR CONTROLLING OF UNWATED VEGETATION See Plans and Pricing
Australia 672361 See Plans and Pricing
Norway 2005018 See Plans and Pricing
New Zealand 214631 2-(2'-NITROBENZOYL)-1,3-CYCLOHEXANEDIONE DERIVATIVES AND HERBICIDES See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ORFADIN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0591275 05C0024 France See Plans and Pricing PRODUCT NAME: NITISINONE; REGISTRATION NO/DATE: EU/1/04/303/001 20050221
0591275 C300198 Netherlands See Plans and Pricing PRODUCT NAME: NITISINONE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAAR DBAAR ZOUT; REGISTRATION NO/DATE: EU/1/04/303/001-003 20050201
0186118 SPC/GB05/037 United Kingdom See Plans and Pricing PRODUCT NAME: A COMBINATION OF TERBUTHYLAZINE AND MESOTRIONE; REGISTERED: DK 1-186 20050203; UK 0805 OF 2005 20050425
0591275 CA 2005 00029 Denmark See Plans and Pricing
0591275 24/2005 Austria See Plans and Pricing PRODUCT NAME: NITISINON ODER EIN PHARMAZEUTISCH ZULAESSIGES SALZ HIERVON; REGISTRATION NO/DATE: EU/1/04/303/001- EU/1/04/303/003 20050221
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Medtronic
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.