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Last Updated: August 4, 2020

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ORFADIN Drug 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. Three suppliers are listed for this compound. Additional details are available on the nitisinone profile page.

US ANDA Litigation and Generic Entry Outlook for Orfadin

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

  Start Trial

Summary for ORFADIN
International Patents:24
US Patents:1
Applicants:1
NDAs:2
Suppliers / Packagers: 1
Bulk Api Vendors: 96
Clinical Trials: 11
Drug Prices: Drug price information for ORFADIN
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

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   Start Trial   Start Trial   Start Trial
Swedish Orphan ORFADIN nitisinone CAPSULE;ORAL 021232-004 Jun 13, 2016 RX Yes Yes   Start Trial   Start Trial   Start Trial
Swedish Orphan ORFADIN nitisinone CAPSULE;ORAL 021232-002 Jan 18, 2002 AB RX Yes No   Start Trial   Start Trial   Start Trial
Swedish Orphan ORFADIN nitisinone CAPSULE;ORAL 021232-003 Jan 18, 2002 AB RX Yes No   Start Trial   Start Trial   Start Trial
>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 021232-003 Jan 18, 2002   Start Trial   Start Trial
Swedish Orphan ORFADIN nitisinone CAPSULE;ORAL 021232-001 Jan 18, 2002   Start Trial   Start Trial
Swedish Orphan ORFADIN nitisinone CAPSULE;ORAL 021232-002 Jan 18, 2002   Start Trial   Start Trial
Swedish Orphan ORFADIN nitisinone CAPSULE;ORAL 021232-003 Jan 18, 2002   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for ORFADIN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0591275 24/2005 Austria   Start Trial PRODUCT NAME: NITISINON ODER EIN PHARMAZEUTISCH ZULAESSIGES SALZ HIERVON; REGISTRATION NO/DATE: EU/1/04/303/001- EU/1/04/303/003 20050221
0591275 C300198 Netherlands   Start Trial PRODUCT NAME: NITISINONE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAAR DBAAR ZOUT; REGISTRATION NO/DATE: EU/1/04/303/001-003 20050201
0591275 CA 2005 00029 Denmark   Start Trial
0137963 97C0042 Belgium   Start Trial PRODUCT NAME: 2-(2-BENZOYL-SUBSTITUE)-1,3-CYCLOHEXANE-DIONES; REGISTRATION NO/DATE: 8452/B 19930121
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Dow
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Medtronic
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McKesson

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