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JAYPIRCA Drug Patent Profile

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Which patents cover Jaypirca, 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-four patent family members in thirty-eight 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

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Summary for JAYPIRCA

International Patents:	74
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	23
Clinical Trials:	1
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

Drug patent expirations by year for JAYPIRCA

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

Generic Entry Date for JAYPIRCA^: ⤷ Sign Up* 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.

Recent Clinical Trials for JAYPIRCA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Medical College of Wisconsin	Phase 1

See all JAYPIRCA clinical trials

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

US Patents and Regulatory Information for JAYPIRCA

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

Based on analysis by DrugPatentWatch, the earliest date for a generic version of JAYPIRCA is ⤷ Sign Up.

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

Compounds useful as kinase inhibitors
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Compounds useful as kinase inhibitors
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY MANTLE CELL LYMPHOMA (MCL) AFTER AT LEAST TWO LINES OF SYSTEMIC THERAPY, INCLUDING A BTK INHIBITOR

Compounds useful as kinase inhibitors
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: 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

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY MANTLE CELL LYMPHOMA (MCL) AFTER AT LEAST TWO LINES OF SYSTEMIC THERAPY, INCLUDING A BTK INHIBITOR

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: 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

FDA Regulatory Exclusivity protecting JAYPIRCA

TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY MANTLE CELL LYMPHOMA (MCL) AFTER AT LEAST TWO LINES OF SYSTEMIC THERAPY, INCLUDING A BTK INHIBITOR
Exclusivity Expiration: ⤷ Sign Up

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up

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
Exclusivity Expiration: ⤷ Sign Up

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Glossary

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

EU/EMA Drug Approvals for JAYPIRCA

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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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for JAYPIRCA

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

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Country	Patent Number	Title	Estimated Expiration
Morocco	49809	Composés utilisés comme inhibiteurs de kinase	⤷ Sign Up
Israel	276283	תרכובות המשמשות כמעכבי קינאז (Compounds useful as kinase inhibitors)	⤷ Sign Up
Spain	2828431		⤷ Sign Up
Slovenia	3390395		⤷ Sign Up
Ukraine	127863	СПОЛУКИ, ЯКІ МОЖНА ЗАСТОСОВУВАТИ ЯК ІНГІБІТОРИ КІНАЗИ	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for JAYPIRCA

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3390395	CA 2024 00006	Denmark	⤷ Sign Up	PRODUCT NAME: PIRTOBRUTINIB; REG. NO/DATE: EU/1/23/1738 20231031
3390395	122024000010	Germany	⤷ Sign Up	PRODUCT NAME: PIRTOBRUTINIB; REGISTRATION NO/DATE: EU/1/23/1738 20231031
3390395	4/2024	Austria	⤷ Sign Up	PRODUCT NAME: PIRTOBRUTINIB; REGISTRATION NO/DATE: EU/1/23/1738 (MITTEILUNG) 20231031
3390395	2024C/506	Belgium	⤷ Sign Up	PRODUCT NAME: PIRTOBRUTINIB; AUTHORISATION NUMBER AND DATE: EU/1/23/1738 20231031
3390395	PA2024506	Lithuania	⤷ Sign Up	PRODUCT NAME: PIRTOBRUTINIBAS; REGISTRATION NO/DATE: EU/1/23/1738 20231030
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description