Lupin intros Tamiflu generic
Lupin has launched its generic of Tamiflu (oseltamivir) capsules. The drug is indicated to treat acute, uncomplicated influenza A and B in patients 2 weeks of age and older who’ve shown symptoms for no more than 48 hours. It also is indicated to prevent the flu in patients age 1 year and older.
Lupin’s generic will be available in 30-, 45- and 75-mg (base) dosage strengths. The product had U.S. sales of roughly $518 million for the 12 months ended December 2017, according to IQVIA data.
Gilead’s freshly approved Biktarvy faces patent hurdle
Gilead Sciences’ new HIV treatment Biktarvy has been approved by the Food and Drug Administration — but its novel component is also the subject of patent infringement litigation from GSK.
Biktarvy is a triple-therapy HIV treatment that brings together bictegravir’s unboosted integrase strand transfer inhibitor with the dual nucleoside transcriptase inhibitor backbone of emtricitabine, tenofovir alafenamide — which are the two components of Gilead’s Descovy.
“Gilead is committed to improving care and simplifying therapy for people living with HIV. We continue to invest in research in next-generation treatments, including therapies that could potentially cure HIV patients,” Gilead president and CEO John Milligan said. “We are pleased to offer Biktarvy, our latest triple-therapy treatment, which brings together the potency of an integrase inhibitor with the most-prescribed dual-NRTI backbone in a once-daily single tablet regimen.”
However, now bictegravir is at the center of GSK’s lawsuit, which was filed in the U.S. District Court for the District of Delaware, as well as in Canadian Federal Court in Toronto. GSK’s majority-owned Viiv Healthcare said it is looking to prove that Biktarvy’s use of bictegravir infringes on a patent covering its dolutegravir and other compounds that use dolutegravir’s chemical scaffold. The company said it would seek financial redress.
“Intellectual property protections are critical for the life-sciences industry, allowing companies to make a return on their investment, which in turn enables research-based companies to put new funding into research and development,” GSK said. “It is this cycle which continues to result in the development of new and much-needed treatments for people living with HIV.”
NCPA survey: Independents feel hampered by DIR fees
Independent pharmacists are indicated to the National Community Pharmacists Association that it should continue to make the case for reform around direct and indirect remuneration, or DIR, fees. The Alexandria, Va.-based group recently conducted a survey of its members in which 84% said they felt DIR fees hinder their businesses.
Seventy-eight percent of independent pharmacists said that DIR fees hinder their ability to plan for their businesses’ future, with three-quarters saying the fees make their cashflow unpredictable. Pharmacists also recognized that patients feel the impact of DIR fees, too, with 69% of those surveyed saying cost-sharing levels increase as a result of the fees, raising a patient’s out-of-pocket costs. And 87% said that DIR fees push patients into the Medicare Part D coverage gap faster, which can lead to high out-of-pocket costs.
“Our members say fixing retroactive pharmacy DIR fees should be NCPA’s priority for 2018,” NCPA CEO Doug Hoey said. “The results of this recent survey will help us make the case to CMS and members of Congress that a fix is needed, and it’s needed now. … The only realistic solution is to end the retroactive nature of DIR fees — whether through S. 413 / H.R. 1038, the Improving Transparency and Accuracy in Medicare Part D Drug Spending Act, or by the Centers for Medicare & Medicaid Services flexing their regulatory muscles in a similar manner.”
NCPA attached the survey results to recent comments it sent to CMS regarding its proposed rule for 2019 Medicare Part D plans, which included a request for information on a potential proposal to include DIR fees at the point of sale.
“We commend CMS for addressing in this proposed rule troublesome practices in the Part D program and encourage the agency to implement these provisions to produce greater convenience and savings for Medicare beneficiaries and greater transparency and fairness for pharmacies,” Hoey said in January.