Binimetinib's patent status is primarily detailed in documents such as WO2003077914A1 [1]. This patent application, filed by Array BioPharma, describes compounds that include binimetinib, which is a MEK inhibitor [1][2].
When Does Binimetinib's Key Patent Expire?
The patent WO2003077914A1, related to binimetinib, was filed on September 12, 2003 [1]. Patent terms typically last 20 years from the filing date, though extensions can be granted. For this specific patent, the 20-year term would have ended in September 2023, assuming no further extensions or other related patents. DrugPatentWatch.com tracks patent expiry dates for pharmaceutical products [3].
What Other Patents Cover Binimetinib?
Beyond the WO2003077914A1 application, binimetinib is likely covered by multiple patents related to its composition of matter, manufacturing processes, and methods of use [3]. These additional patents can extend market exclusivity for the drug. For instance, patents may cover specific crystalline forms or combination therapies involving binimetinib.
What is Binimetinib Used For?
Binimetinib is a targeted therapy approved for use in combination with encorafenib to treat certain types of melanoma [4]. Specifically, it is indicated for patients with BRAF V600E or V600K mutations [4]. It works by inhibiting MEK1 and MEK2 enzymes, which are part of the MAPK signaling pathway, often dysregulated in cancer cells [2].
Who Makes Binimetinib?
Binimetinib is manufactured and marketed by different companies depending on the region and specific product. In the United States, it is marketed by Pfizer under the brand name Braftovi, in combination with encorafenib (also Braftovi) [4]. Array BioPharma, the originator of the compound, was acquired by Pfizer in 2019 [5].
What are the Side Effects of Binimetinib?
Common side effects associated with binimetinib treatment, particularly when used in combination with encorafenib, include fatigue, nausea, diarrhea, vomiting, and musculoskeletal pain [4]. More serious side effects can occur, and patients should discuss any concerns with their healthcare provider [4].
How Does Binimetinib Compare to Other Melanoma Treatments?
Binimetinib, in combination with encorafenib, offers a targeted therapy option for patients with specific genetic mutations in their melanoma [4]. It targets the BRAF-MEK pathway, providing an alternative to broader chemotherapy or immunotherapy treatments, especially for those with BRAF V600 mutations [2][4]. The efficacy and side effect profile of this combination are compared against other treatment regimens during clinical trials [4].
Can Generic or Biosimilar Versions of Binimetinib Be Developed?
The development of generic versions of small molecule drugs like binimetinib is possible once the relevant patents expire and regulatory hurdles are cleared [3]. However, the timeline for generic entry depends on the specific patents protecting the drug, including any patent term extensions or other exclusivity periods granted [3]. Biosimilars are relevant for biologic drugs, not small molecules like binimetinib.
What is the Mechanism of Action for Binimetinib?
Binimetinib is a potent and selective inhibitor of MEK1 and MEK2 enzymes [2]. These enzymes are key components of the RAS-RAF-MEK-ERK (MAPK) signaling pathway, which regulates cell proliferation and survival [2]. In cancers with activating mutations in BRAF or RAS, this pathway is often constitutively active, driving tumor growth [2]. By inhibiting MEK, binimetinib effectively blocks downstream signaling, leading to reduced tumor cell proliferation and increased apoptosis [2].
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Sources:
[1] WO2003077914A1 - AMIDE DERIVATIVES AS MEK INHIBITORS
https://patents.google.com/patent/WO2003077914A1/en
[2] H. H. Wu, et al., "Binimetinib (MEK162): a potent and selective MEK1/2 inhibitor," Journal of Medicinal Chemistry, vol. 56, no. 8, pp. 3422-3433, 2013.
[3] DrugPatentWatch
https://drugpatentwatch.com/
[4] Braftovi (encorafenib and binimetinib) prescribing information. Pfizer.
[5] Pfizer Completes Acquisition of Array BioPharma. (2019, July 26). Pfizer. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-completes-acquisition-of-array-biopharma