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Details for New Drug Application (NDA): 021232
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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.
Summary for 021232
Tradename: | ORFADIN |
Applicant: | Swedish Orphan |
Ingredient: | nitisinone |
Patents: | 0 |
Pharmacology for NDA: 021232
Mechanism of Action | Hydroxyphenylpyruvate Dioxygenase Inhibitors Cytochrome P450 2C9 Inhibitors |
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: | RX | Dosage: | CAPSULE;ORAL | Strength | 2MG | ||||
Approval Date: | Jan 18, 2002 | TE: | AB | 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: | RX | Dosage: | CAPSULE;ORAL | Strength | 5MG | ||||
Approval Date: | Jan 18, 2002 | TE: | AB | 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: | RX | Dosage: | CAPSULE;ORAL | Strength | 10MG | ||||
Approval Date: | Jan 18, 2002 | TE: | AB | 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 | 021232-002 | 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 |
Swedish Orphan | ORFADIN | nitisinone | CAPSULE;ORAL | 021232-001 | Jan 18, 2002 | Start Trial | Start Trial |
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 |
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