PIRTOBRUTINIB - Generic Drug Details

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What are the generic drug sources for pirtobrutinib and what is the scope of patent protection?

Pirtobrutinib is the generic ingredient in one branded drug marketed by Loxo Oncol and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Pirtobrutinib has seventy-five patent family members in thirty-eight countries.

One supplier is listed for this compound.

Summary for PIRTOBRUTINIB

International Patents:	75
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	23
Clinical Trials:	24
Patent Applications:	16
What excipients (inactive ingredients) are in PIRTOBRUTINIB?	PIRTOBRUTINIB excipients list
DailyMed Link:	PIRTOBRUTINIB at DailyMed

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

Generic Entry Date for PIRTOBRUTINIB^: ⤷ 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 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 PIRTOBRUTINIB

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

Sponsor	Phase
Medical College of Wisconsin	Phase 1
Dana-Farber Cancer Institute	Phase 2
Australasian Leukaemia and Lymphoma Group	Phase 2

See all PIRTOBRUTINIB clinical trials

Pharmacology for PIRTOBRUTINIB

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 PIRTOBRUTINIB

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 PIRTOBRUTINIB

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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	216059-002	Jan 27, 2023		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ 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
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				⤷ 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 PIRTOBRUTINIB

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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 PIRTOBRUTINIB

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Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2017103611		⤷ Sign Up
South Korea	20210018530		⤷ Sign Up
South Africa	202107472	COMPOUNDS USEFUL AS KINASE INHIBITORS	⤷ Sign Up
Serbia	60982	JEDINJENJA KORISNA KAO INHIBITORI KINAZE (COMPOUNDS USEFUL AS KINASE INHIBITORS)	⤷ Sign Up
China	114634447		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for PIRTOBRUTINIB

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3390395	PA2024506	Lithuania	⤷ Sign Up	PRODUCT NAME: PIRTOBRUTINIBAS; REGISTRATION NO/DATE: EU/1/23/1738 20231030
3390395	4/2024	Austria	⤷ Sign Up	PRODUCT NAME: PIRTOBRUTINIB; REGISTRATION NO/DATE: EU/1/23/1738 (MITTEILUNG) 20231031
3390395	C03390395/01	Switzerland	⤷ Sign Up	PRODUCT NAME: PIRTOBRUTINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68733 30.11.2023
3390395	301262	Netherlands	⤷ Sign Up	PRODUCT NAME: PIRTOBRUTINIB; REGISTRATION NO/DATE: EU/1/23/1738 20231031
3390395	LUC00330	Luxembourg	⤷ Sign Up	PRODUCT NAME: PIRTOBRUTINIB; AUTHORISATION NUMBER AND DATE: EU/1/23/1738 20231031
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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