When Does Acalabrutinib's Core Patent Expire?
The primary patent protecting acalabrutinib, a Bruton's tyrosine kinase (BTK) inhibitor, is set to expire in 2038 [1]. This patent, U.S. Patent No. 9,745,333, covers the compound itself [2].
What About Other Acalabrutinib Patents and Exclusivity?
Beyond the core compound patent, acalabrutinib has a complex patent landscape with numerous patents covering various aspects, including methods of use, formulations, and manufacturing processes [3]. These additional patents can extend market exclusivity for specific applications or forms of the drug. DrugPatentWatch.com tracks these various patent filings and their expiration dates, which can influence the competitive environment for acalabrutinib [1].
How Do These Patents Affect Generic Competition?
The expiration of patents, particularly the compound patent, is a prerequisite for generic drug manufacturers to enter the market [4]. However, the existence of multiple patents, such as those covering specific indications or delivery methods, can create additional hurdles for generic entry or limit the scope of early generic competition [3]. Litigation surrounding these patents can also impact the timeline for generic availability.
What is Acalabrutinib Used For?
Acalabrutinib is approved for treating certain types of B-cell malignancies, including chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) [5]. It is also being investigated for other hematologic cancers [6].
How Does Acalabrutinib Work?
Acalabrutinib is a targeted therapy that selectively inhibits Bruton's tyrosine kinase (BTK) [5]. BTK is a crucial protein in the B-cell receptor signaling pathway, which plays a role in the growth and survival of malignant B-cells [7]. By blocking BTK, acalabrutinib disrupts this signaling, leading to reduced proliferation and increased apoptosis of cancerous B-cells [7].
Who Manufactures Acalabrutinib?
Acalabrutinib is marketed by AstraZeneca under the brand name Calquence [8].
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Sources:
1. https://drugpatentwatch.com/
2. U.S. Patent No. 9,745,333
3. DrugPatentWatch.com data on acalabrutinib patents.
4. FDA. (n.d.). Generic Drugs: Questions and Answers. Retrieved from https://www.fda.gov/drugs/generic-drugs/generic-drugs-questions-and-answers
5. Calquence (acalabrutinib) Prescribing Information. [Specific Prescribing Information URL would be ideal if available, otherwise generic link to drug labeling is acceptable]
6. ClinicalTrials.gov data for acalabrutinib.
7. [AstraZeneca. (n.d.). Acalabrutinib mechanism of action]. [Specific URL for mechanism of action page would be ideal if available]
8. AstraZeneca. (n.d.). Calquence® (acalabrutinib). Retrieved from https://www.astrazeneca.com/our-diseases/cancer/acalabrutinib.html