Allergan plc, a leading global pharmaceutical company, confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) seeking approval to market Paclitaxel Protein-Bound Particles for injectable suspension, 100 mg/vial.
Allergan's ANDA product is a generic version of Celgene's Abraxane, which is indicated for the treatment of metastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy; locally advanced or metastatic non-small cell lung cancer (NSCLC), as first-line treatment in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy; and metastatic adenocarcinoma of the pancreas as first-line treatment, in combination with gemcitabine.
Based on available information, Allergan believes it is a "first applicant" to file an ANDA for the generic version of Abraxane and, should it's ANDA be approved, may be entitled to 180 days of generic market exclusivity.
For the 12 months ending January 31, 2016, Abraxane had total US sales of approximately $683 million, according to IMS Health data.
Abraxane is a registered trademark of Abraxis BioScience, LLC.
Allergan plc, headquartered in Dublin, Ireland, is a unique, global pharmaceutical company and a leader in a new industry model - Growth Pharma. Allergan is focused on developing, manufacturing and commercializing innovative branded pharmaceuticals, high-quality generic and over-the-counter medicines and biologic products for patients around the world.