Get our Free Drug Patent Expiration Updates

Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
Johnson and Johnson
Medtronic
Healthtrust
Moodys
Fish and Richardson
Cipla
Cantor Fitzgerald
Chubb

Generated: November 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021232

« Back to Dashboard

NDA 021232 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 021232
Tradename:ORFADIN
Applicant:Swedish Orphan
Ingredient:nitisinone
Patents:0
Suppliers and Packaging for NDA: 021232
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ORFADIN nitisinone CAPSULE;ORAL 021232 NDA SWEDISH ORPHAN BIOVITRUM AB (PUBL) 66658-102 66658-102-60 1 BOTTLE, PLASTIC in 1 CARTON (66658-102-60) > 60 CAPSULE in 1 BOTTLE, PLASTIC
ORFADIN nitisinone CAPSULE;ORAL 021232 NDA SWEDISH ORPHAN BIOVITRUM AB (PUBL) 66658-105 66658-105-60 1 BOTTLE, PLASTIC in 1 CARTON (66658-105-60) > 60 CAPSULE in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength2MG
Approval Date:Jan 18, 2002TE: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

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength5MG
Approval Date:Jan 18, 2002TE: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

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength10MG
Approval Date:Jan 18, 2002TE: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

Expired US Patents for NDA 021232

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

This preview shows a limited data set.
Subscribe to access the full database, or try a Free Trial

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
Cipla
Medtronic
UBS
Deloitte
Harvard Business School
Daiichi Sankyo
Dow
Cantor Fitzgerald

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 verifification 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.