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Details for New Drug Application (NDA): 208462
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NDA 208462 describes NINLARO, which is a drug marketed by Millennium Pharms and is included in one NDA. It is available from one supplier. There are nine patents protecting this drug. Additional details are available on the NINLARO profile page.
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.
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: | Millennium Pharms |
| Ingredient: | ixazomib citrate |
| Patents: | 9 |
Generic Entry Opportunity 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 | Millennium Pharmaceuticals, 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 | Millennium Pharmaceuticals, Inc. | 63020-079 | 63020-079-02 | 3 BLISTER PACK in 1 CARTON (63020-079-02) > 1 CAPSULE in 1 BLISTER PACK (63020-079-01) |
Paragraph IV (Patent) Challenges for 208462
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| NINLARO | CAPSULE;ORAL | ixazomib citrate | 208462 | 2019-11-20 |
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, 2020 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| 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: | Start 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 | ||||||||
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