FiercePharma
| Eric Palmer Mar 4, 2019
Pharma companies do their best
to fight off patent expirations and generic competition as long as possible to
protect their big moneymakers. But this year looks like the end of the
line for many of the industry's top brands.
Pfizer’s Lyrica,
GlaxoSmithKline’s Advair, Roche’s Rituxan, Gilead’s Harvoni and many
other drugs are slated or expected to face new generic competition this year.
Each has navigated a different path to the patent cliff, but they'll all end up
delivering a heavy financial blow to their makers.
For several companies
included in the list, new generic pressure is already here. Amgen, for
instance, started dealing with competition for Neulasta and
Epogen last year, thanks to biosimilars from Mylan, Coherus and
Pfizer. It remains to be seen just how much—and how quickly—biosimilars will
hurt the profitable brands.
Other drugs face more
uncertainty as they lose some of their IP protections. Enbrel, for instance, is
another profitable drug that's nearing the cliff, but Amgen executives
recently said their court fight against would-be biosim rival Sandoz will take
a while to play out, so it's uncertain when the drug could face competition.
No bigger lineup of drugs is
facing copycats for the first time than the one at Roche. Executives for the
cancer giant have told investors they're expecting U.S. competition in 2019 for
Rituxan, Herceptin and Avastin. Together, the trio of cancer megablockbusters
pulled in more than $10 billion in the U.S. last year, Roche reported,
representing a huge target for biosim companies.
Pfizer’s Lyrica and Glaxo’s
Advair are two household names making an appearance in this year's
ranking—again. Pfizer was slated to lose Lyrica exclusivity at the end of last
year, but the FDA blessed the drugmaker with a 6-month extension for
testing the drug in a set of pediatric patients. Glaxo, for its part, will
finally face new Advair competition after numerous delays among would-be copycats. Mylan
just recently scored FDA approval for its generic, and the company launched it
in February.
Gilead expects new pain
from generics this year as well, although part of the damage will be
self-inflicted. In a novel twist, Gilead decided to launch authorized generics
to two of its big-selling hepatitis C products, Epclusa and Harvoni,
because competition in the market had grown so fierce that launching cheap
copycats actually benefited the drugmaker. The reasoning? Gilead’s
drugs might reach more patients and generate new sales if offered at a lower
retail price.
But Gilead won’t face new
generic competition only in hepatitis C this year. Executives previously
predicted that pulmonary arterial hypertension drug Letairis would
face generics last year, but those rivals never came. Now, they’re calling
for a second-quarter generic launch. They also expect chest pain drug Ranexa to
face fresh generic erosion in 2019.
At press time, Eli Lilly said
it was preparing to launch an authorized generic to its Humalog insulin, which
pulled in $1.79 billion in the U.S. last year. That would rank it fifth on this
list.
Of course, our
annual patent expiration list wouldn’t be complete without a controversial
drug. This year, that position easily goes to Allergan’s Restasis, which
executives expect to lose exclusivity this year. Pharma watchers will remember
Allergan’s move in 2017 to transfer the drug’s patents to the Saint Regis
Mohawk Tribe, hoping to use sovereign immunity as a shield against
patent attack. The company’s efforts to defend the much-maligned strategy in
the courts have so far been unsuccessful, and now Allergan says its 2019
forecasts are based on Restasis generics launching after March 31.
Each drug on this list faces
the threat of likely—or certain—competition in 2019. The list doesn’t
include patent expirations that aren’t likely to yield new copycats.
Bristol-Myers Squibb's Orencia is one example. The drug will
lose a key patent in 2019, but others don't expire until years later, and no
biosim makers appear ready to launch.
Roche’s arthritis drug
Actemra is another such case; one biosim company called
Bio-Thera Solutions said it’s aiming for a 2021 approval filing on its
Actemra biosimilar. And Johnson & Johnson's
Invega Sustenna has a patent that expires in May 2019, but another is
in force until January 2031, according to a note from Bernstein
analyst Ronny Gal, and it's fighting in court to defend that patent against
Teva generics. It's unclear whether Teva or any other generics
maker could possibly reach the market this year.
To compile this list,
FiercePharma used an OptumRx generic pipeline forecast, plus company conference calls, SEC filings, analyst reports and data from
life science commercial intelligence firm Evaluate. The drugs are ranked
by U.S. sales in 2018.
Top 10 drugs losing
exclusivity in 2019
