ACALABRUTINIB - Generic Drug Details
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What are the generic sources for acalabrutinib and what is the scope of patent protection?
Acalabrutinib
is the generic ingredient in one branded drug marketed by Astrazeneca and is included in two NDAs. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.Acalabrutinib has one hundred and eighty patent family members in forty-nine countries.
One supplier is listed for this compound. There is one tentative approval for this compound.
Summary for ACALABRUTINIB
International Patents: | 180 |
US Patents: | 9 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 53 |
Clinical Trials: | 131 |
Patent Applications: | 1,237 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ACALABRUTINIB |
What excipients (inactive ingredients) are in ACALABRUTINIB? | ACALABRUTINIB excipients list |
DailyMed Link: | ACALABRUTINIB at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ACALABRUTINIB
Generic Entry Date for ACALABRUTINIB*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;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 ACALABRUTINIB
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University Hospital of Gießen and Marburg, Molecular Pathology | Phase 3 |
University Hospital Regensburg, Nuclear Medicine | Phase 3 |
Saarland Universtity Medical Center, Radiology | Phase 3 |
Generic filers with tentative approvals for ACALABRUTINIB
Applicant | Application No. | Strength | Dosage Form |
⤷ Try a Trial | ⤷ Try a Trial | 100MG | CAPSULE;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for ACALABRUTINIB
Drug Class | Kinase Inhibitor |
Mechanism of Action | Tyrosine Kinase Inhibitors |
Paragraph IV (Patent) Challenges for ACALABRUTINIB
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
CALQUENCE | Capsules | acalabrutinib | 100 mg | 210259 | 5 | 2021-11-01 |
US Patents and Regulatory Information for ACALABRUTINIB
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 | 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 | ⤷ Try a Trial | |||
Astrazeneca | CALQUENCE | acalabrutinib | CAPSULE;ORAL | 210259-001 | Oct 31, 2017 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | 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 |
EU/EMA Drug Approvals for ACALABRUTINIB
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
AstraZeneca AB | Calquence | acalabrutinib | EMEA/H/C/005299 Calquence as monotherapy or in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).Calquence as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy. |
Authorised | no | no | no | 2020-11-05 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for ACALABRUTINIB
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 5826931 | ⤷ Try a Trial | |
Argentina | 099934 | COMBINACIÓN TERAPÉUTICA DE UN INHIBIDOR DE PI3K Y UN INHIBIDOR DE BTK | ⤷ Try a Trial |
Spain | 2904707 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ACALABRUTINIB
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
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 | 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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