Details for New Drug Application (NDA): 208712
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NDA 208712 describes VONJO, which is a drug marketed by Sobi 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 VONJO profile page.
The generic ingredient in VONJO is pacritinib citrate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the pacritinib citrate profile page.
The generic ingredient in VONJO is pacritinib citrate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the pacritinib citrate profile page.
Summary for 208712
| Tradename: | VONJO |
| Applicant: | Sobi |
| Ingredient: | pacritinib citrate |
| Patents: | 3 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 208712
Generic Entry Date for 208712*:
Constraining patent/regulatory exclusivity:
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 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: | ⤷ Start Trial | Patent Expiration: | Jan 17, 2029 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | TREATMENT OF MYELOFIBROSIS WITH PACRITINIB | ||||||||
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