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Top 10 drugs losing exclusivity in 2019

Some of pharma’s biggest drugs by sales are slated to lose exclusivity in 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

  • 1. Rituxan
  • 2. Lyrica
  • 3. Herceptin
  • 4. Avastin
  • 5. Epclusa and Harvoni
  • 6. Sensipar
  • 7. Advair
  • 8. Restasis
  • 9. Letairis
  • 10. Suboxone film