ACALABRUTINIB MALEATE - Generic Drug Details
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What are the generic drug sources for acalabrutinib maleate and what is the scope of patent protection?
Acalabrutinib maleate
is the generic ingredient in one branded drug marketed by Astrazeneca and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.Acalabrutinib maleate has one hundred and eighty patent family members in forty-nine countries.
One supplier is listed for this compound.
Summary for ACALABRUTINIB MALEATE
| International Patents: | 180 |
| US Patents: | 7 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 2 |
| Patent Applications: | 10 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ACALABRUTINIB MALEATE |
| DailyMed Link: | ACALABRUTINIB MALEATE at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ACALABRUTINIB MALEATE
Generic Entry Date for ACALABRUTINIB MALEATE*:
Constraining patent/regulatory exclusivity:
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.
Pharmacology for ACALABRUTINIB MALEATE
| Drug Class | Kinase Inhibitor |
| Mechanism of Action | Tyrosine Kinase Inhibitors |
US Patents and Regulatory Information for ACALABRUTINIB MALEATE
International Patents for ACALABRUTINIB MALEATE
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Hungary | E041987 | ⤷ Try a Trial | |
| Denmark | 2734522 | ⤷ Try a Trial | |
| Malaysia | 193514 | SOLID FORMS AND FORMULATIONS OF (S)-4-(8-AMINO-3-(1-(BUT-2-YNOYL)PYRROLIDIN-2-YL)IMIDAZO[1, 5-A]PYRAZIN-1-YL)-N-(PYRIDIN-2-YL)BENZAMIDE | ⤷ Try a Trial |
| Portugal | 2734522 | ⤷ Try a Trial | |
| Eurasian Patent Organization | 201691169 | ТЕРАПЕВТИЧЕСКАЯ КОМБИНАЦИЯ ИНГИБИТОРА PI3K И ИНГИБИТОРА BTK | ⤷ Try a Trial |
| Australia | 2016286548 | Solid forms and formulations of (S)-4-(8-amino-3-(1 -(but-2-ynoyl)pyrrolidin-2-yl)imidazo(1,5-a)pyrazin-1-yl)-N-(pyridiN-2-yl)benzamide | ⤷ Try a Trial |
| Taiwan | 201628620 | Compositions and methods for treatment of chronic lymphocytic leukemia and small lymphocytic leukemia using a BTK inhibitor | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ACALABRUTINIB MALEATE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2734522 | C20210006 00368 | Estonia | ⤷ Try a Trial | PRODUCT NAME: AKALABRUTINIIB;REG NO/DATE: EU/1/20/1479 06.11.2020 |
| 2734522 | 122021000020 | Germany | ⤷ Try a Trial | PRODUCT NAME: ACALABRUTINIB ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/20/1479 20201105 |
| 2734522 | LUC00202 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: ACALABRUTINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/20/1479 20201106 |
| 2734522 | C202130014 | Spain | ⤷ Try a Trial | PRODUCT NAME: ACALABRUTINIB O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/20/1479; DATE OF AUTHORISATION: 20201105; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1479; DATE OF FIRST AUTHORISATION IN EEA: 20201105 |
| 2734522 | 2021C/512 | Belgium | ⤷ Try a Trial | PRODUCT NAME: ACALABRUTINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/20/1479 20201106 |
| 2734522 | PA2021004,C2734522 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: AKALABRUTINIBAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; REGISTRATION NO/DATE: EU/1/20/1479/001-EU/1/20/1479/002 20201105 |
| 2734522 | 21C1014 | France | ⤷ Try a Trial | PRODUCT NAME: ACALABRUTINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/20/1479 20201106 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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.
ISSN: 2162-2639
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