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Last Updated: July 13, 2024

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-three patent family members in thirty-seven countries.

One supplier is listed for this compound.

Summary for pirtobrutinib
International Patents:73
US Patents:4
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 23
Clinical Trials: 14
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*:
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

SponsorPhase
Dana-Farber Cancer InstitutePhase 2
Australasian Leukaemia and Lymphoma GroupPhase 2
The Leukemia and Lymphoma SocietyPhase 2

See all pirtobrutinib clinical trials

US Patents and Regulatory Information for pirtobrutinib

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 216059-001 Jan 27, 2023 RX Yes No ⤷  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 216059-001 Jan 27, 2023 RX Yes No ⤷  Sign Up ⤷  Sign Up Y Y ⤷  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

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

Supplementary Protection Certificates for pirtobrutinib

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3390395 LUC00330 Luxembourg ⤷  Sign Up PRODUCT NAME: PIRTOBRUTINIB; AUTHORISATION NUMBER AND DATE: EU/1/23/1738 20231031
3390395 301262 Netherlands ⤷  Sign Up PRODUCT NAME: PIRTOBRUTINIB; REGISTRATION NO/DATE: EU/1/23/1738 20231031
3390395 2024C/506 Belgium ⤷  Sign Up PRODUCT NAME: PIRTOBRUTINIB; AUTHORISATION NUMBER AND DATE: EU/1/23/1738 20231031
3390395 122024000010 Germany ⤷  Sign Up PRODUCT NAME: PIRTOBRUTINIB; REGISTRATION NO/DATE: EU/1/23/1738 20231031
3390395 CR 2024 00006 Denmark ⤷  Sign Up 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.