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12 March 2024

Patent Updates

Olaparib Comes Off Patent

Olaparib is indicated for:
Ovarian cancer
– for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.)
– in combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either:
– a deleterious or suspected deleterious BRCA mutation, and/or
– genomic instability.

Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza
– for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in complete or partial response to platinum-based chemotherapy.
– for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.

Breast cancer
– for the treatment of adult patients with deleterious or suspected deleterious gBRCAm, HER2-negative metastatic breast cancer who have been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be
considered inappropriate for endocrine therapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.

Pancreatic cancer
– for the maintenance treatment of adult patients with deleterious or suspected deleterious gBRCAm metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.
Prostate cancer
– for the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza. Olaparib was developed by Kudos Pharmaceuticals Limited.
The API has now reached off-patent status, after being launched in 2014.

The information provided above is sourced from Chemrobotics PharmaVetPat https://chemroboticspharma.com/pharmVetPat
to find out more, including patent landscape and routes of synthesis, please contact our sales team.

According to PharmaTrade, Olaparib was exported from India in 2023 , with an average price over the period of $8340 /kg.
The key suppliers were Hetero Drugs, with a focus on markets in Central & South America.

For enquiries regarding more detailed trade data of Olaparib and many others, contact info@pharmacheminvestor.com

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