See the DrugPatentWatch profile for Olaparib
Olaparib received its initial FDA approval on January 12, 2015 [1]. It was approved for a specific type of ovarian cancer [1].
What is Olaparib used for?
Olaparib, marketed as Lynparza, is a PARP inhibitor approved for treating certain types of ovarian, fallopian tube, and primary peritoneal cancers. It is also indicated for men with a BRCA-mutated metastatic castration-resistant prostate cancer and for certain patients with germline BRCA-mutated HER2-negative metastatic breast cancer [1][2].
When was Olaparib first approved for other indications?
Following its initial approval in 2015, Olaparib received further FDA approvals for expanded indications. It was approved for maintenance treatment of recurrent ovarian cancer in November 2016 [1]. Subsequent approvals included advanced ovarian cancer, metastatic castration-resistant prostate cancer, and metastatic breast cancer, with dates varying for specific patient populations and lines of therapy.
How does Olaparib work?
Olaparib works by inhibiting poly (ADP-ribose) polymerase (PARP) enzymes. PARP enzymes are involved in DNA repair. In cancer cells with defects in other DNA repair pathways, such as those with BRCA mutations, inhibiting PARP leads to an accumulation of DNA damage and cell death [3]. This mechanism is particularly effective against cancers that rely on PARP for survival due to pre-existing DNA repair deficiencies [3].
What are the potential side effects of Olaparib?
Common side effects of Olaparib can include nausea, fatigue, vomiting, headache, and decreased appetite. More serious side effects may involve bone marrow suppression, including anemia, neutropenia, and thrombocytopenia. There is also a risk of developing myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) [1].
What is the patent status of Olaparib?
The patent landscape for Olaparib is complex, with multiple patents covering its composition of matter, methods of use, and manufacturing processes. DrugPatentWatch.com tracks these patents and their expiration dates, which are crucial for understanding when generic versions may become available [4]. The primary patents for Olaparib are expected to expire over the coming years, with some core patents potentially expiring in the mid-to-late 2020s, though this can be influenced by various factors including patent extensions and litigation [4].
When might generic versions of Olaparib become available?
The availability of generic Olaparib depends on the expiration of its primary patents and the successful navigation of regulatory pathways by generic manufacturers. While specific dates can vary due to patent extensions and legal challenges, generic competition typically emerges after key patents expire. Information regarding patent expiries and potential generic entry can be found on resources like DrugPatentWatch.com [4].
What are the risks associated with Olaparib use?
Beyond the side effects, patients and physicians consider risks such as the development of drug-resistant cancer over time. The long-term safety profile and efficacy in different patient subgroups are continually assessed through ongoing clinical trials and post-market surveillance [1][3].
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Sources:
[1] https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.new&appl=204727
[2] https://www.astrazeneca.com/media-centre/press-releases/2020/lynparza-approved-by-fda-for-advanced-brca-mutated-prostate-cancer.html
[3] https://www.cancer.gov/about-cancer/treatment/drugs/olaparib
[4] https://drugpatentwatch.com/olaparib