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 five 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:	5
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^: ⤷ Subscribe* 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	10,695,323	⤷ Subscribe	Y	Y		⤷ Subscribe
Loxo Oncol	JAYPIRCA	pirtobrutinib	TABLET;ORAL	216059-001	Jan 27, 2023		RX	Yes	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Loxo Oncol	JAYPIRCA	pirtobrutinib	TABLET;ORAL	216059-001	Jan 27, 2023		RX	Yes	No	12,109,193	⤷ Subscribe	Y			⤷ Subscribe
Loxo Oncol	JAYPIRCA	pirtobrutinib	TABLET;ORAL	216059-001	Jan 27, 2023		RX	Yes	No	10,918,622	⤷ Subscribe				⤷ Subscribe
Loxo Oncol	JAYPIRCA	pirtobrutinib	TABLET;ORAL	216059-002	Jan 27, 2023		RX	Yes	Yes	10,342,780	⤷ Subscribe	Y	Y		⤷ Subscribe
>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
Morocco	49809	Composés utilisés comme inhibiteurs de kinase	⤷ Subscribe
Lithuania	3390395		⤷ Subscribe
China	108473481	可用作激酶抑制剂的化合物 (COMPOUNDS USEFUL AS KINASE INHIBITORS)	⤷ Subscribe
South Korea	102215792		⤷ Subscribe
China	113603645	可用作激酶抑制剂的化合物 (Compounds useful as kinase inhibitors)	⤷ Subscribe
>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	122024000010	Germany	⤷ Subscribe	PRODUCT NAME: PIRTOBRUTINIB; REGISTRATION NO/DATE: EU/1/23/1738 20231031
3390395	CA 2024 00006	Denmark	⤷ Subscribe	PRODUCT NAME: PIRTOBRUTINIB; REG. NO/DATE: EU/1/23/1738 20231031
3390395	2024C/506	Belgium	⤷ Subscribe	PRODUCT NAME: PIRTOBRUTINIB; AUTHORISATION NUMBER AND DATE: EU/1/23/1738 20231031
3390395	LUC00330	Luxembourg	⤷ Subscribe	PRODUCT NAME: PIRTOBRUTINIB; AUTHORISATION NUMBER AND DATE: EU/1/23/1738 20231031
3390395	CR 2024 00006	Denmark	⤷ Subscribe	PRODUCT NAME: PIRTOBRUTINIB; REG. NO/DATE: EU/1/23/1738 20231031
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.