Details for New Drug Application (NDA): 021856
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NDA 021856 describes ULORIC, which is a drug marketed by Takeda Pharms Usa and is included in one NDA. It is available from one supplier. There are three patents protecting this drug and one Paragraph IV challenge. Additional details are available on the ULORIC profile page.
The generic ingredient in ULORIC is febuxostat. There are twenty-six drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the febuxostat profile page.
The generic ingredient in ULORIC is febuxostat. There are twenty-six drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the febuxostat profile page.
Summary for 021856
| Tradename: | ULORIC |
| Applicant: | Takeda Pharms Usa |
| Ingredient: | febuxostat |
| Patents: | 3 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 021856
| Mechanism of Action | Xanthine Oxidase Inhibitors |
Medical Subject Heading (MeSH) Categories for 021856
Suppliers and Packaging for NDA: 021856
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ULORIC | febuxostat | TABLET;ORAL | 021856 | NDA | Takeda Pharmaceuticals America, Inc. | 64764-677 | 64764-677-11 | 10 BLISTER PACK in 1 CARTON (64764-677-11) / 10 TABLET in 1 BLISTER PACK |
| ULORIC | febuxostat | TABLET;ORAL | 021856 | NDA | Takeda Pharmaceuticals America, Inc. | 64764-677 | 64764-677-13 | 100 TABLET in 1 BOTTLE (64764-677-13) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 40MG | ||||
| Approval Date: | Feb 13, 2009 | TE: | AB | RLD: | Yes | ||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Mar 8, 2024 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Sep 8, 2031 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | USE OF FEBUXOSTAT FOR THE MANAGEMENT OF HYPERURICEMIA IN PATIENTS SUFFERING FROM GOUT AND, WHEN USED WITH THEOPHYLLINE WITHOUT THE NEED FOR DOSE ADJUSTMENT OF THEOPHYLLINE | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Sep 8, 2031 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | USE OF FEBUXOSTAT FOR THE MANAGEMENT OF HYPERURICEMIA IN PATIENTS SUFFERING FROM GOUT AND, WHEN USED WITH THEOPHYLLINE WITHOUT THE NEED FOR DOSE ADJUSTMENT OF THEOPHYLLINE | ||||||||
Expired US Patents for NDA 021856
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Takeda Pharms Usa | ULORIC | febuxostat | TABLET;ORAL | 021856-001 | Feb 13, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
| Takeda Pharms Usa | ULORIC | febuxostat | TABLET;ORAL | 021856-001 | Feb 13, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
| Takeda Pharms Usa | ULORIC | febuxostat | TABLET;ORAL | 021856-002 | Feb 13, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
| Takeda Pharms Usa | ULORIC | febuxostat | TABLET;ORAL | 021856-002 | Feb 13, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
| Takeda Pharms Usa | ULORIC | febuxostat | TABLET;ORAL | 021856-001 | Feb 13, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
| Takeda Pharms Usa | ULORIC | febuxostat | TABLET;ORAL | 021856-002 | Feb 13, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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