Details for New Drug Application (NDA): 216873
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NDA 216873 describes OJJAARA, which is a drug marketed by Glaxosmithkline and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the OJJAARA profile page.
The generic ingredient in OJJAARA is momelotinib dihydrochloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the momelotinib dihydrochloride profile page.
The generic ingredient in OJJAARA is momelotinib dihydrochloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the momelotinib dihydrochloride profile page.
Summary for 216873
| Tradename: | OJJAARA |
| Applicant: | Glaxosmithkline |
| Ingredient: | momelotinib dihydrochloride |
| Patents: | 5 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 216873
Generic Entry Date for 216873*:
Constraining patent/regulatory exclusivity:
TREATMENT OF INTERMEDIATE OR HIGH-RISK MYELOFIBROSIS (MF), INCLUDING PRIMARY MF OR SECONDARY MF [POST-POLYCYTHEMIA VERA (PV) AND POST-ESSENTIAL THROMBOCYTHEMIA (ET)], IN ADULTS WITH ANEMIA Dosage:
TABLET;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: 216873
| Mechanism of Action | Breast Cancer Resistance Protein Inhibitors Kinase Inhibitors |
Suppliers and Packaging for NDA: 216873
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OJJAARA | momelotinib dihydrochloride | TABLET;ORAL | 216873 | NDA | GlaxoSmithKline LLC | 81864-101 | 81864-101-30 | 30 TABLET in 1 BOTTLE (81864-101-30) |
| OJJAARA | momelotinib dihydrochloride | TABLET;ORAL | 216873 | NDA | GlaxoSmithKline LLC | 81864-102 | 81864-102-30 | 30 TABLET in 1 BOTTLE (81864-102-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 100MG BASE | ||||
| Approval Date: | Sep 15, 2023 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Sep 15, 2028 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Sep 15, 2030 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF INTERMEDIATE OR HIGH-RISK MYELOFIBROSIS (MF), INCLUDING PRIMARY MF OR SECONDARY MF [POST-POLYCYTHEMIA VERA (PV) AND POST-ESSENTIAL THROMBOCYTHEMIA (ET)], IN ADULTS WITH ANEMIA | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Dec 2, 2040 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | FOR THE TREATMENT OF INTERMEDIATE OR HIGH-RISK MYELOFIBROSIS IN SUBJECTS HAVING A BASELINE PLATELET COUNT OF LESS THAN 50 BILLION/L | ||||||||
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