Details for New Drug Application (NDA): 217379
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NDA 217379 describes CAVHANZA, which is a drug marketed by Flex Pharma and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the CAVHANZA profile page.
The generic ingredient in CAVHANZA is nilotinib. There are eleven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the nilotinib profile page.
The generic ingredient in CAVHANZA is nilotinib. There are eleven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the nilotinib profile page.
Summary for 217379
| Tradename: | CAVHANZA |
| Applicant: | Flex Pharma |
| Ingredient: | nilotinib |
| Patents: | 4 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 217379
Generic Entry Date for 217379*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET, ORALLY DISINTEGRATING;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.
Pharmacology for NDA: 217379
Suppliers and Packaging for NDA: 217379
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CAVHANZA | nilotinib | TABLET, ORALLY DISINTEGRATING;ORAL | 217379 | NDA | Cycle Pharmaceuticals Ltd | 70709-191 | 70709-191-12 | 112 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (70709-191-12) |
| CAVHANZA | nilotinib | TABLET, ORALLY DISINTEGRATING;ORAL | 217379 | NDA | Cycle Pharmaceuticals Ltd | 70709-192 | 70709-192-12 | 112 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (70709-192-12) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 60MG | ||||
| Approval Date: | May 29, 2026 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Jan 29, 2041 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | USE OF NILOTINIB FOR TREATMENT OF ADULT PATIENTS WITH CHRONIC PHASE AND ACCELERATED PHASE PH+ CHRONIC MYELOID LEUKEMIA RESISTANT TO OR INTOLERANT TO PRIOR THERAPY THAT INCLUDED IMATINIB, WHEN ADMINISTERED WITH FOOD OR IN FED STATE | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Jan 29, 2041 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | USE OF NILOTINIB FOR TREATMENT OF ADULT PATIENTS WITH NEWLY DIAGNOSED PH+ CHRONIC MYELOID LEUKEMIA IN CHRONIC PHASE, WHEN ADMINISTERED WITH FOOD OR IN FED STATE | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Apr 30, 2041 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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