A decade in the biopharma world has a way of featuring some megablockbuster patent losses, often forcing top drugmakers to fight off cheaper competition as discounted generics rush to steal share. And the last 10 years have taken that pattern to new—even record-setting—heights.
Together, the 10 biggest drugs losing IP protections since 2007 will account for more than $915 billion in lifetime sales, according to data compiled by life science commercial intelligence firm Evaluate. The top drug is the biggest patent expiration of all time at a mind-blowing $179 billion, according to the analysts, but that doesn't mean it'll quickly face competition.
AbbVie’s Humira, which still has some protections thanks to add-on patents and ongoing litigation, is the biggest expiration of the decade. AbbVie’s patent for “human antibodies that bind human TNF alpha” expired at the end of 2016, but the drugmaker expects to have protection until 2022, executives have said.
RELATED: Top 10 U.S. patent losses of 2017
Despite that patent expiration last year, analysts with Evaluate predict the drug’s peak sales year will be 2019, when they expect Humira to bring in $19.36 billion in sales. That means the drug's post-2016 sales will be a significant addition to the drug’s total lifetime haul.
The rest of the meds among the top 10 patent expirations of 2007 to 2017 didn't rack up as much during their blockbuster monopolies, but each of them is still on track to bring in more than $60 billion in total lifetime sales, according to the firm’s data.
Pfizer’s megablockbuster cholesterol med Lipitor isn't too far behind Humira. The drug’s total lifetime take is expected to come in at $149 billion, according to Evaluate. Its peak sales year was 2006, when the Pfizer med brought in nearly $13 billion. After losing exclusivity in 2011, Lipitor’s sales contribution fell considerably for Pfizer, from $9.57 billion that year to $3.94 billion in 2012. But still, the brand has managed to hang onto blockbuster sales; according to Evaluate research, it brought in $1.75 billion in 2016.
Meanwhile, with a total lifetime sales haul of $101 billion, GlaxoSmithKline’s Advair earned the third spot in Evaluate’s ranking. The drug’s composition of matter patent expired in 2010 and its inhaler patent expired last year, but Advair still hasn’t faced an exact generic competitor because the drug/device combo has been tough for generics companies to replicate. Teva already launched a competing product, though it doesn’t have exactly the same label, so it's not substitutable at the pharmacy. That fact has limited its uptake. Mylan plans to launch its copycat next year and Jordan's Hikma said this week it expects its own generic rollout in 2018 or 2019.
In the cases of Humira and Advair, key patent losses obviously didn’t mean immediate competition. AbbVie is still fighting off biosimilar launches as a host of developers race for their chance to steal Humira market share, but the company contends its add-on patents will provide years of exclusive protections. Amgen already has an approved biosim, but hasn’t launched the product due to legal hurdles.
Sanofi’s big-selling insulin Lantus earned the fourth spot in the decade’s top patent losses ranked by lifetime sales. That drug, which has ceded considerable market share and pricing power in recent years, posted its best year ever in 2014 at $8.24 billion, according to Evaluate. Lantus’ total lifetime sales are expected to amount to more than $80 billion.
Under a patent settlement, Eli Lilly and Boehringer Ingelheim launched a biosim, Basaglar, in late 2016 to take a stab at the branded med’s U.S. sales. Merck & Co. is aiming for its own Lantus biosimilar, but patent litigation is likely to tie it up for a couple years.
Johnson & Johnson’s Remicade rounds out the top five, with a predicted total lifetime haul of $75 billion. The drug lost patent protections last year and it turned in nearly $7 billion for the period. The New Jersey drug giant is fighting off a biosim assault from several companies, with copycats already dealing particular damage to the brand in Europe, where Merck & Co. has marketing rights. Samsung and Merck recently launched their Remicade biosim in the U.S. at a 35% discount, a move that followed Pfizer’s launch for Inflectra at a 15% discount.
Still, J&J is holding on to branded sales by setting up exclusive contracts, bundling products together for large hospitals and offering deeper discounts to large independent infusion centers. It remains to be seen how much damage the competing biosims will deal to the brand.
Rounding out the top 10 patent expirations for the decade are AstraZeneca’s purple pill Nexium with $69 billion in lifetime sales, Amgen’s Neulasta with $69 billion in lifetime sales, Novartis’ Diovan, AstraZeneca’s Crestor and Pfizer’s Norvasc, each with more than $62 billion in anticipated lifetime sales, according to Evaluate. Pfizer’s Norvasc had the earliest patent expiration of the group by far, with its protections running out way back in 2007. All sales data were provided in August 2017, with lifetime revenue projections running through 2022.
Of course, ranking the drugs by top lifetime sales skews the list toward more recent blockbuster patent expirations, with prices higher and drugs leaning to the specialty arena rather than more mainstream meds. For a list of top expirations per year, see the chart below, ranked by Evaluate data on peak sales in one year.