Takeda tries to block Impax’s launch of generic Dexilant
HAYWARD, Calif. — Generic drug maker Impax Labs is hoping to become the first to market a version of a gastroesophageal reflux disease treatment made by Takeda Pharmaceutical.
Impax said Tuesday that it had filed an approval application with the Food and Drug Administration for dexlansoprazole delayed-release capsules in the 30-mg and 60-mg strengths. The drug is a version of Takeda’s Dexilant.
The application contained a Paragraph IV certification, a legal assertion that the patents covering Dexilant are invalid, unenforceable or not infringed. Takeda filed suit against Impax in the U.S. District Court for the Northern District of California on Friday to prevent the launch, Impax said.
Dexilant delayed-release capsules had sales of $20 million in the 30-mg strength and $261 million in the 60-mg strength during the 12 months ended in January, according to Wolters Kluwer Health.
Upon FDA approval, Impax expects entitlement to 180 days of market exclusivity in which to compete directly with Takeda’s branded version of the drug. Patents covering Dexilant are scheduled to expire in 2020, 2026 and 2027, according to FDA records.
BioPlus appoints chief strategic officer
ALTAMONTE SPRINGS, Fla. — A former MedfusionRx VP has joined BioPlus as its new chief strategic officer.
In his new role, Russell Gay will provide key leadership for all of the business development at BioPlus, including the strengthening and growth of relationships with payers, physicians, the pharmaceutical industry and various industry partners, BioPlus said.
Gay is an industry veteran with 25 years in the healthcare industry. While serving as MedFusionRx VP, he played a significant role in building that company into one of the largest specialty pharmacies in the United States.
“Russell is tasked with developing and diversifying our business. He shares our values, understands the intricacies of the specialty infusion market, and appreciates our unique position of leading measurable outcomes,” said Stephen Vogt, BioPlus president and CEO. “Russell’s business experience in the key areas of infusion, home care and specialty have prepared him well to lead our business development.”
Bioniche Pharma launches generic Sandostatin
PITTSBURGH — Mylan subsidiary Bioniche Pharma has launched an injectable treatment for a rare metabolic disorder, Mylan said Tuesday.
Mylan announced the launch of octreotide acetate injection in prefilled syringes, a generic version of Novartis’ Sandostatin, used to treat the disorder acromegaly and suppress or inhibit severe diarrhea related to certain tumors. Acromegaly results from excess growth hormone produced in the pituitary gland, causing fatigue and weakness, body odor and carpal tunnel syndrome.
“This approval is particularly important because it is the first and only [prefilled syringe] for this product — branded or generic — providing hospitals and clinics access to a preferred presentation that offers ease, accuracy and convenience of dosing,” Mylan Institutional president Matt Erick said.
Ocreotide acetate injection had sales of about $579 million in 2010, according to IMS Health.