Details for New Drug Application (NDA): 022075
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NDA 022075 describes NOURIANZ, which is a drug marketed by Kyowa Kirin and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the NOURIANZ profile page.
The generic ingredient in NOURIANZ is istradefylline. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the istradefylline profile page.
The generic ingredient in NOURIANZ is istradefylline. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the istradefylline profile page.
Summary for 022075
| Tradename: | NOURIANZ |
| Applicant: | Kyowa Kirin |
| Ingredient: | istradefylline |
| Patents: | 3 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 022075
Generic Entry Date for 022075*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Suppliers and Packaging for NDA: 022075
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NOURIANZ | istradefylline | TABLET;ORAL | 022075 | NDA | Kyowa Kirin, Inc. | 42747-602 | 42747-602-07 | 1 BLISTER PACK in 1 BOX (42747-602-07) / 7 TABLET, FILM COATED in 1 BLISTER PACK |
| NOURIANZ | istradefylline | TABLET;ORAL | 022075 | NDA | Kyowa Kirin, Inc. | 42747-602 | 42747-602-90 | 90 TABLET, FILM COATED in 1 BOTTLE (42747-602-90) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
| Approval Date: | Aug 27, 2019 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Aug 27, 2024 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Nov 13, 2024 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patent: | ⤷ Try a Trial | Patent Expiration: | Jan 28, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | A METHOD OF REDUCING OFF TIME FROM L-DOPA THERAPY, COMPRISING ADMINISTERING, TO A HUMAN PATIENT WITH PARKINSON'S DISEASE, AN EFFECTIVE AMOUNT OF ISTRADEFYLLINE, WHEREIN THE PATIENT CURRENTLY RECEIVES SAID L-DOPA THERAPY | ||||||||
Expired US Patents for NDA 022075
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Kyowa Kirin | NOURIANZ | istradefylline | TABLET;ORAL | 022075-002 | Aug 27, 2019 | ⤷ Try a Trial | ⤷ Try a Trial |
| Kyowa Kirin | NOURIANZ | istradefylline | TABLET;ORAL | 022075-001 | Aug 27, 2019 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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