Details for New Drug Application (NDA): 208462
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The generic ingredient in NINLARO is ixazomib citrate. One supplier is listed for this compound. Additional details are available on the ixazomib citrate profile page.
Summary for 208462
Tradename: | NINLARO |
Applicant: | Takeda Pharms Usa |
Ingredient: | ixazomib citrate |
Patents: | 9 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 208462
Generic Entry Date for 208462*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;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: 208462
Mechanism of Action | Proteasome Inhibitors |
Suppliers and Packaging for NDA: 208462
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NINLARO | ixazomib citrate | CAPSULE;ORAL | 208462 | NDA | Takeda Pharmaceuticals America, Inc. | 63020-078 | 63020-078-02 | 3 BLISTER PACK in 1 CARTON (63020-078-02) / 1 CAPSULE in 1 BLISTER PACK (63020-078-01) |
NINLARO | ixazomib citrate | CAPSULE;ORAL | 208462 | NDA | Takeda Pharmaceuticals America, Inc. | 63020-079 | 63020-079-02 | 3 BLISTER PACK in 1 CARTON (63020-079-02) / 1 CAPSULE in 1 BLISTER PACK (63020-079-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 2.3MG BASE | ||||
Approval Date: | Nov 20, 2015 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Nov 20, 2022 | ||||||||
Regulatory Exclusivity Use: | USE IN COMBINATION WITH LENALIDOMIDE AND DEXAMETHASONE FOR THE TREATMENT OFPATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY | ||||||||
Patent: | ⤷ Try a Trial | Patent Expiration: | Nov 20, 2029 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Patented Use: | USE IN COMBINATION WITH LENALIDOMIDE AND DEXAMETHASONE FOR THE TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY | ||||||||
Patent: | ⤷ Try a Trial | Patent Expiration: | Aug 6, 2027 | Product Flag? | Y | Substance Flag? | Y | Delist Request? |
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