JAYPIRCA Drug Patent Profile
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When do Jaypirca patents expire, 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-five 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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Questions you can ask:
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Summary for JAYPIRCA
| International Patents: | 75 |
| 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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for JAYPIRCA
Generic Entry Date for JAYPIRCA*:
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:
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 |
Pharmacology for JAYPIRCA
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
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
| 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 | ||||
| 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 | ||||
| >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
| 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.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Morocco | 49809 | Composés utilisés comme inhibiteurs de kinase | ⤷ Sign Up |
| Israel | 285976 | ⤷ Sign Up | |
| Morocco | 49809 | ⤷ Sign Up | |
| Morocco | 55064 | COMPOSÉS UTILISÉS COMME INHIBITEURS DE KINASE | ⤷ Sign Up |
| Eurasian Patent Organization | 035132 | СОЕДИНЕНИЯ, КОТОРЫЕ МОЖНО ПРИМЕНЯТЬ В КАЧЕСТВЕ ИНГИБИТОРОВ КИНАЗЫ (COMPOUNDS USEFUL AS KINASE INHIBITORS) | ⤷ Sign Up |
| Australia | 2021225162 | Compounds useful as kinase inhibitors | ⤷ Sign Up |
| Singapore | 10202012498T | COMPOUNDS USEFUL AS KINASE INHIBITORS | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for JAYPIRCA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 3390395 | 2024C/506 | Belgium | ⤷ Sign Up | PRODUCT NAME: PIRTOBRUTINIB; AUTHORISATION NUMBER AND 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 | CR 2024 00006 | Denmark | ⤷ Sign Up | PRODUCT NAME: PIRTOBRUTINIB; REG. NO/DATE: EU/1/23/1738 20231031 |
| 3390395 | PA2024506 | Lithuania | ⤷ Sign Up | PRODUCT NAME: PIRTOBRUTINIBAS; REGISTRATION NO/DATE: EU/1/23/1738 20231030 |
| 3390395 | 122024000010 | Germany | ⤷ Sign Up | PRODUCT NAME: PIRTOBRUTINIB; REGISTRATION NO/DATE: EU/1/23/1738 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 |
| >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.
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