Acalabrutinib maleate - Generic Drug Details
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What are the generic 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 |
Anatomical Therapeutic Chemical (ATC) Classes for acalabrutinib maleate
US Patents and Regulatory Information for acalabrutinib maleate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Astrazeneca | CALQUENCE | acalabrutinib maleate | TABLET;ORAL | 216387-001 | Aug 3, 2022 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Astrazeneca | CALQUENCE | acalabrutinib maleate | TABLET;ORAL | 216387-001 | Aug 3, 2022 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Astrazeneca | CALQUENCE | acalabrutinib maleate | TABLET;ORAL | 216387-001 | Aug 3, 2022 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Astrazeneca | CALQUENCE | acalabrutinib maleate | TABLET;ORAL | 216387-001 | Aug 3, 2022 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Astrazeneca | CALQUENCE | acalabrutinib maleate | TABLET;ORAL | 216387-001 | Aug 3, 2022 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Astrazeneca | CALQUENCE | acalabrutinib maleate | TABLET;ORAL | 216387-001 | Aug 3, 2022 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for acalabrutinib maleate
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| South Africa | 202000300 | 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 |
| Australia | 2022291635 | 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 |
| China | 103889987 | 4-imidazopyridazin-1-yl-benzamides and 4-imidazotriazin-1-yl-benzamides as btk-inhibitors | ⤷ Try a Trial |
| Singapore | 10201605913V | 4-IMIDAZOPYRIDAZIN-1-YL-BENZAMIDES AND 4-IMIDAZOTRIAZIN-1-YL-BENZAMIDES AS BTK-INHIBITORS | ⤷ Try a Trial |
| New Zealand | 620085 | 4-imidazopyridazin-1-yl-benzamides and 4-imidazotriazin-1-yl-benzamides as btk-inhibitors | ⤷ Try a Trial |
| Israel | 230511 | (s)-4-(8-אמינו-3-(1-בוט-2-ינוייל-פירולידינ-2-יל)אימידאזו[5,1-a]פיראזינ-1-יל)-n-(פירידינ-2-יל)בנזאמיד כמעכב btk ((s)-4-(8-amino-3-(1-but-2-ynoylpyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-yl)-n-(pyridin-2-yl)benzamide as 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 | CA 2021 00007 | Denmark | ⤷ Try a Trial | PRODUCT NAME: ACALABRUTINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/20/1479 20201106 |
| 2734522 | 122021000020 | Germany | ⤷ Try a Trial | PRODUCT NAME: ACALABRUTINIB ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/20/1479 20201105 |
| 2734522 | 2021016 | Norway | ⤷ Try a Trial | PRODUCT NAME: AKALABRUTINIB; REG. NO/DATE: EU/1/20/1479 20201111 |
| 2734522 | PA2021004 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: AKALABRUTINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/20/1479/001-EU/1/20/1479/002 20201105 |
| 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 | C02734522/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: ACALABRUTINIBUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67790 04.03.2021 |
| >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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