Details for New Drug Application (NDA): 217759
✉ Email this page to a colleague
NDA 217759 describes JOENJA, which is a drug marketed by Pharming and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the JOENJA profile page.
The generic ingredient in JOENJA is leniolisib phosphate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the leniolisib phosphate profile page.
The generic ingredient in JOENJA is leniolisib phosphate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the leniolisib phosphate profile page.
Summary for 217759
| Tradename: | JOENJA |
| Applicant: | Pharming |
| Ingredient: | leniolisib phosphate |
| Patents: | 1 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 217759
Generic Entry Date for 217759*:
Constraining patent/regulatory exclusivity:
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.
Suppliers and Packaging for NDA: 217759
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| JOENJA | leniolisib phosphate | TABLET;ORAL | 217759 | NDA | Pharming Healthcare Inc. | 71274-170 | 71274-170-60 | 1 BOTTLE, PLASTIC in 1 CARTON (71274-170-60) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 70MG BASE | ||||
| Approval Date: | Mar 24, 2023 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Mar 24, 2028 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Mar 24, 2030 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF ACTIVATED PHOSPHOINOSITIDE 3-KINASE DELTA (PI3K DELTA) SYNDROME (APDS) IN ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Feb 19, 2032 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Complete Access Available with Subscription
