Details for New Drug Application (NDA): 208712
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The generic ingredient in VONJO is pacritinib citrate. One supplier is listed for this compound. Additional details are available on the pacritinib citrate profile page.
Summary for 208712
Tradename: | VONJO |
Applicant: | Cti Biopharma Corp |
Ingredient: | pacritinib citrate |
Patents: | 3 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 208712
Generic Entry Date for 208712*:
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: 208712
Suppliers and Packaging for NDA: 208712
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
VONJO | pacritinib citrate | CAPSULE;ORAL | 208712 | NDA | Sobi, Inc. | 72482-100 | 72482-100-12 | 40 CARTON in 1 BOX (72482-100-12) / 1 BOTTLE in 1 CARTON / 120 CAPSULE in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 100MG BASE | ||||
Approval Date: | Feb 28, 2022 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Feb 28, 2027 | ||||||||
Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
Regulatory Exclusivity Expiration: | Feb 28, 2029 | ||||||||
Regulatory Exclusivity Use: | TREATMENT OF ADULTS WITH INTERMEDIATE OR HIGH-RISK PRIMARY OR SECONDARY (POST-POLYCYTHEMIA VERA OR POST-ESSENTIAL THROMBOCYTHEMIA) MYELOFIBROSIS (MF) WITH A PLATELET COUNT BELOW 50 X 10^9/L | ||||||||
Patent: | 8,153,632 | Patent Expiration: | Jan 17, 2029 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Patented Use: | TREATMENT OF MYELOFIBROSIS WITH PACRITINIB |
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