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 patent family members in thirty-five countries.
One supplier is listed for this compound.
Summary for pirtobrutinib
International Patents: | 70 |
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
Sponsor | Phase |
---|---|
Dana-Farber Cancer Institute | Phase 2 |
Australasian Leukaemia and Lymphoma Group | Phase 2 |
Loxo Oncology, Inc. | Phase 2 |
Pharmacology 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 |
International Patents for pirtobrutinib
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Mexico | 2018007267 | COMPUESTOS UTILES COMO INHIBIDORES DE CINASA. (COMPOUNDS USEFUL AS KINASE INHIBITORS.) | ⤷ Try a Trial |
Chile | 2018001591 | Compuestos útiles como inhibidores de cinasa.- | ⤷ Try a Trial |
China | 114716381 | 可用作激酶抑制剂的化合物 (Compounds useful as kinase inhibitors) | ⤷ Try a Trial |
Colombia | 2018006164 | Compuestos útiles como inhibidores de cinasa | ⤷ Try a Trial |
Mexico | 2021003478 | COMPUESTOS UTILES COMO INHIBIDORES DE CINASA. (COMPOUNDS USEFUL AS KINASE INHIBITORS.) | ⤷ Try a Trial |
Ukraine | 127863 | СПОЛУКИ, ЯКІ МОЖНА ЗАСТОСОВУВАТИ ЯК ІНГІБІТОРИ КІНАЗИ | ⤷ Try a Trial |
Slovenia | 3390395 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for pirtobrutinib
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
3390395 | CR 2024 00006 | Denmark | ⤷ Try a Trial | PRODUCT NAME: PIRTOBRUTINIB; REG. NO/DATE: EU/1/23/1738 20231031 |
3390395 | CA 2024 00006 | Denmark | ⤷ Try a Trial | PRODUCT NAME: PIRTOBRUTINIB; REG. NO/DATE: EU/1/23/1738 20231031 |
3390395 | LUC00330 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: PIRTOBRUTINIB; AUTHORISATION NUMBER AND DATE: EU/1/23/1738 20231031 |
3390395 | PA2024506 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: PIRTOBRUTINIBAS; REGISTRATION NO/DATE: EU/1/23/1738 20231030 |
3390395 | 301262 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: PIRTOBRUTINIB; REGISTRATION NO/DATE: EU/1/23/1738 20231031 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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