Among the many meds that’ll lose patent protection in the U.S. this year are 10 drugs that each contribute in a big way for top drugmakers. Eli Lilly, Pfizer, Takeda, Bristol-Myers Squibb and Gilead are each set to hit the patent cliff this year with some of their respective big sellers.
Together, they brought in more than $10 billion last year in the U.S. and cover a range of indications: multiple sclerosis, HIV, erectile dysfunction and cancer, among others. They’ll be hot targets as generic rivals rush to steal share with cheaper options.
Just when a drug will lose market exclusivity isn’t always clear, with add-on patents and legal settlements occasionally clouding the picture. We've focused not only on drugs that will lose their patent shields in 2017, but those that, because of patent litigation or settlements, will find themselves vulnerable to generic or biosimilar competition.
To find the top U.S. patent losses for 2017, FiercePharma consulted life science commercial intelligence firm Evaluate and Drug Patent Watch, plus public securities filings, FDA records, court documents and other sources to navigate the often complicated story of intellectual property in pharmaceuticals.
At the top of the list is Teva's long-acting MS med Copaxone 40 mg—and its story exemplifies that complexity. It's a crucial brand for an ailing drugmaker, with a mighty $3.48 billion in U.S. sales last year, and it's been scrambling to fight off generic challengers in patent court. The med has lost multiple patent challenges in the last year, most recently in January, and though it remains to be seen whether Teva will prevail on appeal, several analysts figure the company will face "at-risk" generic competition this year. And as Teva revealed with its fourth-quarter earnings in mid-February, the company now figures generics, if they do launch, would wipe away $1 billion to $1.3 billion in 2017 sales.
But late Friday, Teva caught a break when Momenta and partner Sandoz reported that an FDA warning letter is poised to delay their Copaxone copycat.
When generics make it to market, branded drugs lose up to 90% of their sales, according to a recent Dickson Data graphic. Drugs that face just one or two copycats at first under Hatch-Waxman Act first-to-file rules will have a six-month scrimmage before the real competition—and real pricing battle—begins against multiple generics. At that point, small-molecule meds typically face copycats that are 80% to 85% cheaper than the originals. Biosimilars, still a nascent field in the U.S., have made their American debuts with discounts of around 15%, though negotiated prices can be lower—and long-term, prices may move lower still.
Following Copaxone is Eli Lilly’s Cialis, a marketing mainstay that’s expected to slide to just $55 million in 2022 sales from a hefty $1.42 billion in 2016, according to EvaluatePharma analysts. Promoted in iconic ads featuring couples in bathtubs, the erectile dysfunction drug will still pull in blockbuster-level sales for 2017, but its freefall is poised to escalate afterward.
Aside from Cialis, Lilly is set to lose patent protection for Strattera and Effient this year, although the latter med didn’t make our top 10 sales threshold. Strattera, in fact, occupies 10th place with $535 million in U.S. sales, according to EvaluatePharma. That’s a figure expected to fall to just $13 million by 2022 as competitors rush in. With those three exclusivity losses looming, and a key Alzheimer's drug study falling short, Lilly said late last year that it plans to stop promoting all three meds and lay off sales staff.
Next on our top 10 list are Pfizer’s blockbuster erectile dysfunction drug Viagra and Takeda’s multiple myeloma med Velcade, which each turned in sales north of $1 billion last year in the U.S. alone.
Pfizer’s notorious blue pill Viagra will face cheap generics from Teva and Mylan in December as part of settlements with each of those companies. To get the most out of its blockbuster brand before generics hit, Pfizer continues to promote the med heavily, most recently with a text-for-coupon campaign. After turning in $1.15 billion in the U.S. last year, Viagra is expected to dwindle to $188 million by 2022, EvaluatePharma's analysts predict.
Velcade, with $1.13 billion in estimated 2016 sales, is set to lose patent protection in November and will cede nearly a billion in yearly sales by 2022, according to the EvaluatePharma sales analysis. Fresenius and Teva each have knockoffs with tentative FDA approvals ready to go, according to the agency’s website.
Next in line is Bristol-Myers' HIV med Sustiva, which turned in $901 million in U.S. sales last year. It loses its monopoly protection in December after first winning FDA approval in 1998, and Teva, Emcure, Strides and Aurobindo each boast a tentatively approved knockoff, according to the agency.
Novartis also is set to suffer a 2017 loss. Sandostatin LAR, used to treat acromegaly and diarrhea associated with certain types of tumors, ranks at No. 6 with $853 million in estimated 2016 sales. Its patent runs out on Dec. 31, but the med will hold on to the bulk of its sales through 2022, according to EP. It's a "complex generic," so the bar for copycat entry is high.
Following in order are Novo Nordisk’s growth hormone Norditropin SimpleXx, delivered in a proprietary pen device; Gilead’s hepatitis B/HIV antiviral Viread; and Pfizer’s antidepressant Pristiq. Each features a unique patent and sales story as the brand braces for generic competition (or not). Strattera rounds out the top 10.
For Gilead, it'll be important to fill Viread's revenue gap as that drug suffers generic erosion at the same time the company's massive hep C sales drag. During its fourth-quarter 2016 conference call, Gilead execs conceded that, because of those revenue shortfalls, M&A is necessary for growth.
Intellectual property obviously is a mainstay in the pharma business, and these exclusivity losses each illustrate that point. Do you have thoughts about U.S. patent rules and litigation? Comments about the drugs on this list. As always, let us know. —Eric Sagonowsky [ email | Twitter ]
Editor's note: Evaluate provided EvaluatePharma sales data and estimates in February 2017.