Dive Brief:
- Teva Pharmaceutical Industries Ltd. last week launched a generic version of Gilead Sciences Inc.'s Viread in the U.S., ushering in copycat competition to the aging HIV and hepatitis B medicine.
- Under a 2013 settlement with Gilead, Teva secured an exclusive window to launch its generic copy. Viread's primary patents expire in 2018, which would open up the drug to further competition from other generic makers.
- The launch gives Teva a small boost in the midst of a corporate crisis, as backlash in the company's home base of Israel mounts to CEO Kåre Schultz's plan to cut 14,000 positions over two years.
Dive Insight:
In 2013, Gilead and Teva reached a deal to settle patent litigation brought by the Israeli company over four patents protecting the active ingredient in Viread, tenofovir disoproxil fumarate (TDF). Under the agreement, Teva was permitted to exclusively launch its generic copy in the U.S. market, beginning on December 15.
That same settlement also concerned Gilead's Atripla (efavirenz/emtricitabine/TDF) and Truvada (emtricitabine/tenofovir), but no dates for a launch of those products are disclosed in Gilead's regulatory filings.
Gilead has extensively prepared for generic competition to its TDF-containing HIV products, rolling out three new medicines over the past four years that rely on a successor active ingredient known as tenofovir alafenamide or TAF.
Sales of Viread in the U.S. totaled $395 million through the first nine months of 2017, down nearly 6% from the same period a year prior. Launch of Teva's copy will take a further slice out of this, putting pressure on Gilead as it fights against tumbling hepatitis C sales.
For Teva, the launch adds its list of almost 600 available generic medicines. The company claims one in seven generic prescriptions dispensed in the U.S. are filled by Teva generics.
Teva is in the midst of a major restructure, planning to cut 25% of its workforce in an effort to lower operating costs and tackle a substantial debt burden. As part of the reorganization, Teva will create a single commercial organization for both commercial and generic products, and sell off facilities as well as non-core drugs.
While belt-tightening might be needed for the generics giant, its actions have triggered mass protest and rallies across Israel, including a public solidarity strike and threats to blow up one of its factories, according to the Times of Israel.