At some point, the patent cliff claims the high-rolling life of market exclusivity for all drugs — and 2021 is, of course, no exception.
Although the industry has been flushed with COVID-related investments since 2020, many companies are still bracing for the impact of oncoming generics competition and what it could mean for their bottom lines.
Not as many drugs are slated to plummet off the cliff in 2021 as in the years to come. Analysts at GreyB, for example, have identified seven key drugs losing exclusivity in 2021, but nearly 20 drugs in 2023, including a few blockbusters such as Novartis’ Entresto and Biogen’s Spinraza.
This year, just one blockbuster — Roche’s Lucentis — is officially losing its exclusivity. Yet, several other major drugs await the same fate.
Here’s a look at 10 drugs facing new copycat competition in 2021.
Originally approved in 2006 for wet age-related macular degeneration (AMD), Roche’s Lucentis reached sales of $1.61 billion in 2020. However, despite approvals for other indications such as macular edema in patients with diabetes, its decline in sales is already underway, and started in 2019 when Novartis launched another drug in this class.
Now, analysts think biosimilars will create an even larger threat to Roche and a biosim application for Lucentis from Samsung Bioepis is already under review by the FDA.
Earlier this year, Novartis, which owns a large stake in Roche, reported that sales for Lucentis plummeted by 25% in Q2.
Manufactured in the U.S. by Galen, Adasuve is an inhaled powder used to treat extreme agitation in adults with bipolar I or schizophrenia. Several of its patents expire in October 2021, potentially opening doors for generic versions.
However, it could be a while before that happens, mainly because there’s no news yet of other manufacturers seizing those opportunities.
Alternatively, a different threat to Galen’s profits may come via newer alternative methods of treating agitation such as BioXcel’s had a sublingual thin film of dexmedetomidine, which is in phase 3 trials.
In June, Mylan’s Perforomist, which treats ongoing lung conditions, including emphysema and chronic bronchitis, lost its patent. In the same month, Teva Pharmaceuticals Industries launched the first generic version of the drug, targeting patients with chronic obstructive pulmonary disease (COPD).
According to Teva, Perforomist reaches annual sales in the U.S. of $299 million. So far, its generic version is the only one to hit the scene.
When Denmark-based Lundbeck, loses patent exclusivity for one of its top-sellers — Northera — this year, the impact for the company will be huge.
According to Reuters, the company has forecasted that sales for Northera, which is used to treat symptoms related to neurogenic orthostatic hypotension, will plummet by half this year as the drug comes off patent.
Overall, the drop in Northera sales will contribute to the company seeing its revenue fall from 17.7 billion Danish crowns in 2020 to 16.3-16.9 billion this year.
Emergent BioSolutions has had its hands full this year with several COVID-19 vaccine-related manufacturing challenges. On top of that, the company is gearing up to lose exclusivity of one of its key products — the opioid overdose drug, Narcan.
The company is currently locked in a patent dispute with Teva Pharmaceutical Industries related to a generic version of the nasal spray. As of June, judges ruled in favor of Teva, but Emergent will appeal.
In 2019, U.S. regulators approved the first generic naloxone nasal spray for people without medical training to use in community settings. Thus, Emergent has already faced competition from generics before losing the patent protection this year. But in 2020, Emergent looked to combat the threat by winning approval for a new version of the drug with an extended shelf life.
Another drug targeting patients with COPD, Sunovion’s Brovana already faced competition in the crowded field for inhalation treatments. Now, with all of its patents expiring this year, the competition from more generics is coming quickly.
In June, Lupin Limited announced that it is launching a generic version of the drug, and numerous other copycats are expected to follow in the second half of 2021.
With sales of $600 million in 2019, Bystolic, a high blood pressure drug made by AbbVie, is one of the largest-growing medications to lose its patent this year. And thanks to a settlement in 2013, a number of generics will be teed up to launch in September.
Not only that, AbbVie was hit with a class-action lawsuit this month alleging that the company’s subsidiary Forest Laboratories paid off rivals to delay copycats of Bystolic from hitting the market.
With AbbVie’s Saphris, which is used to treat certain patients with bipolar disorder and schizophrenia, losing its patent, generics have already hit the market.
In December, Breckenridge Pharmaceutical’s generic version won FDA approval along with others from Alembic Pharmaceuticals and Sigmapharm Laboratories.
Industry analysts estimate that Saphris had a market value of about $239 million between Sept. 2019 and Sept. 2020.
The patent loss of Amitiza earlier this year was another blow in a series of difficulties for Mallinckrodt.
Weighed down by opioid marketing-related litigation and a class-action lawsuit accusing the company of securities fraud related to its Acthar Gel, the drugmaker is in the midst of bankruptcy proceedings.
In addition, Amitiza, an irritable bowel syndrome and constipation drug that generated an estimated $180 million in profits for the company in 2020, began facing generics competition earlier this year.
Gilead Pharmaceuticals’ triple-combination Atripla was developed to prevent the reproduction of the human immunodeficiency virus (HIV) in the body, but has not generated as much income as some of the company’s other HIV treatments. Truvada, for example, pulled in $753 million in sales in the first half of 2020, while Atripla obtained $176 million in sales.
But with several of the drug’s patents expiring this year, including one related to pediatric exclusivity, Teva has already pounced on the opportunity to launch a copycat.
In late 2020, Teva introduced a generic version of Atripla, one of several now on the market.