~ Buy the JAYPIRCA (pirtobrutinib) Drug Profile, 2024 PDF Report in the Report Store ~

JAYPIRCA Drug Patent Profile

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

Jaypirca is a drug marketed by Loxo Oncol and is included in one NDA. There are four patents protecting this drug.

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

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

DrugPatentWatch^® Generic Entry Outlook for Jaypirca

Jaypirca will be eligible for patent challenges on January 27, 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 December 1, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for JAYPIRCA

International Patents:	70
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	23
Patent Applications:	9
Drug Prices:	Drug price information for JAYPIRCA
What excipients (inactive ingredients) are in JAYPIRCA?	JAYPIRCA excipients list
DailyMed Link:	JAYPIRCA at DailyMed

See drug prices for JAYPIRCA

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

Constraining patent/regulatory exclusivity:

TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA OR SMALL LYMPHOCYTIC LYMPHOMA (CLL/SLL) WHO HAVE RECEIVED AT LEAST TWO PRIOR LINES OF THERAPY, INCLUDING A BTK INHIBITOR AND A BCL-2 INHIBITOR

NDA:

216059

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 JAYPIRCA

Drug Class	Kinase Inhibitor
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Bruton's Tyrosine Kinase Inhibitors Cytochrome P450 2C19 Inhibitors Cytochrome P450 2C8 Inhibitors Cytochrome P450 3A Inhibitors P-Glycoprotein Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for JAYPIRCA

L01EL	Bruton's tyrosine kinase (BTK) inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for JAYPIRCA

JAYPIRCA is protected by seven US patents and three FDA Regulatory Exclusivities.

This potential generic entry date is based on TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA OR SMALL LYMPHOCYTIC LYMPHOMA (CLL/SLL) WHO HAVE RECEIVED AT LEAST TWO PRIOR LINES OF THERAPY, INCLUDING A BTK INHIBITOR AND A BCL-2 INHIBITOR.

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 JAYPIRCA

FDA Regulatory Exclusivity protecting JAYPIRCA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Loxo Oncol	JAYPIRCA	pirtobrutinib	TABLET;ORAL	216059-001	Jan 27, 2023		RX	Yes	No
Loxo Oncol	JAYPIRCA	pirtobrutinib	TABLET;ORAL	216059-002	Jan 27, 2023		RX	Yes	Yes
Loxo Oncol	JAYPIRCA	pirtobrutinib	TABLET;ORAL	216059-001	Jan 27, 2023		RX	Yes	No			Y	Y
Loxo Oncol	JAYPIRCA	pirtobrutinib	TABLET;ORAL	216059-002	Jan 27, 2023		RX	Yes	Yes			Y	Y
Loxo Oncol	JAYPIRCA	pirtobrutinib	TABLET;ORAL	216059-002	Jan 27, 2023		RX	Yes	Yes

EU/EMA Drug Approvals for JAYPIRCA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Eli Lilly Nederland B.V.	Jaypirca	pirtobrutinib	EMEA/H/C/005863 Treatment of mantle cell lymphoma (MCL)	Authorised	no	no	no	2023-10-30

International Patents for JAYPIRCA

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

Country	Patent Number	Title	Estimated Expiration
United Kingdom	201613945
Japan	7086140
Hungary	E051921
South Africa	201804137	COMPOUNDS USEFUL AS KINASE INHIBITORS
European Patent Office	3390395	COMPOSÉS UTILISÉS COMME INHIBITEURS DE KINASE (COMPOUNDS USEFUL AS KINASE INHIBITORS)

Supplementary Protection Certificates for JAYPIRCA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3390395	CR 2024 00006	Denmark		PRODUCT NAME: PIRTOBRUTINIB; REG. NO/DATE: EU/1/23/1738 20231031
3390395	CA 2024 00006	Denmark		PRODUCT NAME: PIRTOBRUTINIB; REG. NO/DATE: EU/1/23/1738 20231031
3390395	LUC00330	Luxembourg		PRODUCT NAME: PIRTOBRUTINIB; AUTHORISATION NUMBER AND DATE: EU/1/23/1738 20231031
3390395	PA2024506	Lithuania		PRODUCT NAME: PIRTOBRUTINIBAS; REGISTRATION NO/DATE: EU/1/23/1738 20231030
3390395	301262	Netherlands		PRODUCT NAME: PIRTOBRUTINIB; REGISTRATION NO/DATE: EU/1/23/1738 20231031