FiercePharma | Eric Sagonowsky
Each year, dozens of branded pharmaceutical products lose their patent
protections in a process that routinely paves the way for cheap generics. This
year is no different, and the drugs opening up to copycat competitors
represent some serious sales heft. And as usual, you'll see
some household names at the top of the list of U.S. expirations.
What's different these days can be summed up in one word: biosimilars. In
the past, patent expirations brought immediate generic competition and the
sales hit that come along with them. Now, with biosimilar development a more
spendy and complicated proposition—not to mention the delays triggered by the
biosimilar pathway's "patent dance"—a patent loss doesn't necessarily
open the gates to copycats.
Our No. 1 entry is a case in point. Leading all other drugs in this year’s
top 15 patent expirations is Roche’s mega-blockbuster Rituxan. The drug's
patent expiration comes as a biosimilar threat to that company continues to
creep into the picture, forcing Roche to look to new launches for growth.
Next up is another: Amgen's Neulasta, a white blood cell booster that could
face biosim competition this year from Mylan, provided its version wins FDA
approval. The drug's patent expired in 2015, but so far, biosimilars haven't
made it past FDA gatekeepers.
Thanks to examples like these—where a patent is newly lost but biosims are
uncertain, or where IP protections are already down but the brand still doesn't
face head-to-head copies—FiercePharma broadened its criteria for inclusion
in this report to better reflect the generic and biosim threats.
We allowed drugs that face 2018 patent expirations, even if copycat launch
timing isn't certain, plus drugs whose patents previously expired but
could face brand-new biosimilar or generic competition this year.
One more straightforward loss is Pfizer’s legendary Lyrica. Its market
exclusivity expires with a December patent loss—if, that is, the New York
drugmaker isn’t able to win a pediatric exclusivity that would extend its
monopoly for six months and push competition into next year.
Moving down the list, products from companies large and small face 2018
patent expirations. The report features treatments that have sparked
controversy—Allergan’s Restasis, for example—and even a drug that made last
year’s rundown of top patent expirations: Lilly’s Cialis. That blockbuster drug
was set for a patent loss last year, before Eli Lilly inked a patent settlement
to secure a few more months of branded sales. Together, the 15 branded
drugs on our list were worth nearly $26 billion in U.S. sales last year.
With complex patent shields, litigation and regulatory setbacks, the story
surrounding each of these patent expirations and newly vulnerable drugs is
ever-changing. This report is designed to be a point-in-time look at the
situation surrounding each drug. The lineup could shift by year's end, thanks
to decisions from the FDA, the courts and the U.S. Patent and Trademark
Office—and the companies themselves, as in the case of Cialis.
The top 15 drug patent expirations of 2018
