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JOENJA Drug Patent Profile

When do Joenja patents expire, and when can generic versions of Joenja launch?

Joenja is a drug marketed by Pharming and is included in one NDA. There is one patent protecting this drug.

This drug has forty-five patent family members in thirty-nine countries.

The generic ingredient in JOENJA is leniolisib phosphate. One supplier is listed for this compound. Additional details are available on the leniolisib phosphate profile page.

DrugPatentWatch^® Generic Entry Outlook for Joenja

Joenja will be eligible for patent challenges on March 24, 2027. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 24, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for JOENJA

International Patents:	45
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	8
Drug Prices:	Drug price information for JOENJA
What excipients (inactive ingredients) are in JOENJA?	JOENJA excipients list
DailyMed Link:	JOENJA at DailyMed

See drug prices for JOENJA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for JOENJA

Constraining patent/regulatory exclusivity:

TREATMENT OF ACTIVATED PHOSPHOINOSITIDE 3-KINASE DELTA (PI3K DELTA) SYNDROME (APDS) IN ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER

NDA:

217759

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 JOENJA

Drug Class	Kinase Inhibitor
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Cytochrome P450 1A2 Inhibitors Organic Anion Transporting Polypeptide 1B1 Inhibitors Organic Anion Transporting Polypeptide 1B3 Inhibitors Phosphoinositide 3-Kinase delta Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for JOENJA

L03AX	Other immunostimulants
L03A	IMMUNOSTIMULANTS
L03	IMMUNOSTIMULANTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for JOENJA

JOENJA is protected by one US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on TREATMENT OF ACTIVATED PHOSPHOINOSITIDE 3-KINASE DELTA (PI3K DELTA) SYNDROME (APDS) IN ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting JOENJA

FDA Regulatory Exclusivity protecting JOENJA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pharming	JOENJA	leniolisib phosphate	TABLET;ORAL	217759-001	Mar 24, 2023		RX	Yes	Yes			Y	Y
Pharming	JOENJA	leniolisib phosphate	TABLET;ORAL	217759-001	Mar 24, 2023		RX	Yes	Yes
Pharming	JOENJA	leniolisib phosphate	TABLET;ORAL	217759-001	Mar 24, 2023		RX	Yes	Yes

International Patents for JOENJA

See the table below for patents covering JOENJA around the world.

Country	Patent Number	Title	Estimated Expiration
Argentina	118919	DERIVADOS DE TETRAHIDRO-PIRIDO-PIRIMIDINA
Chile	2013000033	Compuestos derivados de tetrahidro-pirido-pirimidina, moduladores de pi3k; composicion farmaceutica que los comprende; combinacion farmaceutica; proceso de preparacion de estos; y su uso en el tratamiento de una enfermedad inflamatoria, autoinmune, cardiovascular, neurodegenerativa, metabolica, oncologica, entre otras
Japan	2013535411
Brazil	112013000275	derivados de tetraidro-pirido-pirimidina
Denmark	2590974
Taiwan	I534145