Hikma launches generic Zytiga
Hikma announced its generic of Janssen’s Zytiga (abiraterone acetate tablets). The drug will be available in 250-mg dosage strength tablets.
Abiraterone acetate tablets are a CYP17 inhibitor indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer.
In October 2018, the United States District Court for the District of New Jersey’s invalidated a key Zytiga patent.
On Nov. 20, 2018, the United States Court of Appeals for the Federal Circuit denied the patent holder’s request to prevent Hikma’s launching abiraterone acetate tablets pending appeal. Hikma was one of the first ANDA applicants to submit an ANDA with a Paragraph IV certification challenging the validity of certain patents listed for Zytiga tablets, 250mg, and therefore is eligible for 180 days of generic drug exclusivity.
Abiraterone acetate tablets had a market value of approximately $1.8 billion in the 12 months ending December 2018, according to IQVIA.
“We are adding abiraterone acetate tablets to our oncology portfolio, improving patients access to this life-saving product. This launch continues to demonstrate our ability to successfully litigate paragraph IV products, which is an important element of our portfolio strategy,” Hikma president generics division Brian Hoffmann said.
Abiraterone acetate tablets are a CYP17 inhibitor indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer.
In October 2018, the United States District Court for the District of New Jersey’s invalidated a key Zytiga patent.
On Nov. 20, 2018, the United States Court of Appeals for the Federal Circuit denied the patent holder’s request to prevent Hikma’s launching abiraterone acetate tablets pending appeal. Hikma was one of the first ANDA applicants to submit an ANDA with a Paragraph IV certification challenging the validity of certain patents listed for Zytiga tablets, 250mg, and therefore is eligible for 180 days of generic drug exclusivity.
Abiraterone acetate tablets had a market value of approximately $1.8 billion in the 12 months ending December 2018, according to IQVIA.
“We are adding abiraterone acetate tablets to our oncology portfolio, improving patients access to this life-saving product. This launch continues to demonstrate our ability to successfully litigate paragraph IV products, which is an important element of our portfolio strategy,” Hikma president generics division Brian Hoffmann said.