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Covington
Deloitte
Boehringer Ingelheim
Dow
US Army
Chinese Patent Office
Federal Trade Commission
Colorcon
Fuji

Generated: May 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206356

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NDA 206356 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. Two suppliers are listed for this compound. Additional details are available on the nitisinone profile page.
Summary for 206356
Tradename:ORFADIN
Applicant:Swedish Orphan
Ingredient:nitisinone
Patents:1
Therapeutic Class:Enzyme Replacements/Modifiers
Suppliers and Packaging for NDA: 206356
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ORFADIN nitisinone SUSPENSION;ORAL 206356 NDA Swedish Orphan Biovitrum AB (publ) 66658-204 N 66658-204-90

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength4MG/ML
Approval Date:Apr 22, 2016TE:RLD:Yes
Regulatory Exclusivity Expiration:Sep 1, 2020
Regulatory Exclusivity Use:ONCE-DAILY DOSING FOR PATIENTS 5 YEARS OF AGE AND OLDER WHO HAVE UNDETECTABLE SERUM AND URINE SUCCINYLACETONE CONCENTRATIONS AFTER A MINIMUM OF 4 WEEKS ON A STABLE DOSAGE OF NITISINONE
Patent:➤ Sign UpPatent Expiration:Feb 28, 2033Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF HEREDITARY TYROSINEMIA TYPE 1 (HT-1) IN COMBINATION WITH DIETARY RESTRICTION OF TYROSINE AND PHENYLALANIE

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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Cerilliant
Citi
Queensland Health
Argus Health
Medtronic
US Army
QuintilesIMS
Accenture

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