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-three patent family members in thirty-seven 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:
- What is the 5 year forecast for JAYPIRCA?
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Summary for JAYPIRCA
International Patents: | 73 |
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 |
![JAYPIRCA drug patent expirations Drug patent expirations by year for JAYPIRCA](/p/graph/s/t/JAYPIRCA-patent-expirations.png)
![Drug Prices for JAYPIRCA](/p/graph/drug-price/JAYPIRCA.png)
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 | ||
>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 | 42871 | Composés utilisés comme inhibiteurs de la tyrosine kinase de bruton (btk) | ⤷ Sign Up |
China | 114621146 | 可用作激酶抑制剂的化合物 (Compounds useful as kinase inhibitors) | ⤷ Sign Up |
Colombia | 2018006164 | Compuestos útiles como inhibidores de cinasa | ⤷ 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 | CR 2024 00006 | Denmark | ⤷ Sign Up | PRODUCT NAME: PIRTOBRUTINIB; REG. 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 | 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 |