Leniolisib phosphate - Generic Drug Details

What are the generic drug sources for leniolisib phosphate and what is the scope of freedom to operate?

Leniolisib phosphate is the generic ingredient in one branded drug marketed by Pharming and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Leniolisib phosphate has forty-five patent family members in thirty-nine countries.

One supplier is listed for this compound.

Summary for leniolisib phosphate

International Patents:	45
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	8
Patent Applications:	2
DailyMed Link:	leniolisib phosphate at DailyMed

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

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

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 leniolisib phosphate

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 leniolisib phosphate

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

US Patents and Regulatory Information for leniolisib phosphate

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 leniolisib phosphate

Country	Patent Number	Title	Estimated Expiration
Croatia	P20140778
Japan	5770842
Portugal	2590974
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
Ukraine	112517	ТЕТРАГІДРОПІРИДОПІРИМІДИНОВІ ПОХІДНІ
Hong Kong	1179966	四氫-吡啶並-嘧啶衍生物 (TETRAHYDRO-PYRIDO-PYRIMIDINE DERIVATIVES --)