Top-selling drugs from AbbVie Inc.(ABBV, Financial) and Roche (RHHBY, Financial) head the list of medications that will lose patent protection this year. How the losses affect the companies' bottom lines—and perhaps their share price—will depend on how fast generic competitors encroach on their market share, how well other products fill any gaps and the success companies have in protecting their brand name drugs via creative methods.
This year's expected losses of U.S. exclusivity include the Roche macular degeneration blockbuster Lucentis, two medicines from AbbVie and a Pfizer Inc. (PFE, Financial) cancer drug, FiercePharma reported.
The publication acknowledged that the list is its "best attempt" at pinpointing the top 10 medicines, ranked by U.S. sales in 2020, that are likely to face new generics or biosimilars this year. As expected, the impact on the leading drugs isn't as cut and dried as it may appear. Some may avoid copycats due to court rulings, regulatory issues for generics companies or other unanticipated occurrences. And some are already facing generic rivals.
Roche's Lucentis, for wet age-related macular degeneration, had 2020 sales of more than $1.6 billion. That was 19% lower than the previous year, a drop the company attributed to the pandemic. Since 2019, Lucentis has faced competition from the Novartis (NVS) treatment Beovu. But this year, the entire class of drugs could face biosimilars.
Roche said in its annual report that there are "recent and approaching patent expiries in the U.0.S for Lucentis which may have an impact on 2021 sales for this product."
Meanwhile, generic competition for the AbbVie blood pressure drug Bystolic is expected by mid-September. Sales for 2020 were undisclosed, but the medication raked in $600 million in 2019.
AbbVie will also see imitators to its antipsychotic Saphris in 2021. Three generic versions to the drug were launched in December. Although AbbVie didn't break out Saphris sales last year, the market is estimated to be worth about $217 million.
While no company likes to lose market share, the impact of sales declines for the two AbbVie drugs will make a nearly undetectable dent in its 2021 results, given the pharma giant's revenue last year was nearly $46 billion. The company's big challenge comes in 2023, when its mega blockbuster Humira is scheduled to face generic competition. Humira, the world's best-selling drug, added more than $16 billion to AbbVie's top line last year.
To help cushion the impact of expected losses in Humira to generics, the company is devoting substantial resources to figure out ways to boost sales of its new immunology launches Skyrizi and Rinvoq, among other treatments.
Other among the top 10 drugs facing generic competitors this year are:
Vascepa from Amarin Corp. PLC (AMRN, Financial)
- 2020 U.S. sales: $598 million
- Disease: Hypertriglyceridemia and cardiovascular disease
- Generic entry: November 2020
Northera from H. Lundbeck A/S (LUN, Financial)
- 2020 U.S. sales: $416 million
- Disease: Neurogenic orthostatic hypotension
- Expected generic entry: February 2021
Narcan from Emergent BioSolutions Inc. (EBS, Financial)
- 2020 U.S. sales: $311 million
- Disease: Opioid overdose
- Potential generic entry: Second half of 2021
Brovana from Suniovion Pharmaceuticals (private)
- 2020 U.S. sales projection: Around $275 million
- Disease: Chronic obstructive pulmonary disease
- Potential generic entry: Second half of 2021
Sutent from Pfizer Inc.
- 2020 U.S. sales: $223 million
- Disease: gastrointestinal stromal tumors, advanced renal cell carcinoma and pancreatic neuroendocrine tumors
- Potential generic entry: August 2021
Amitiza from Mallinckrodt PLC (MNK, Financial)
- 2020 U.S. sales: About $180 million (estimate)
- Disease: constipation and irritable bowel syndrome
- Generic entry: Jan. 4
Eraheme from Clovis Group
- 2020 U.S. sales: About $150 million (estimate)
- Disease: Iron deficiency anemia
- Potential generic entry: July 2021
It's logical that the bigger the company and the higher its sales, the less impact generics are likely to have on its overall financial results and stock performance. As pointed out by Vakilsearch, most large pharmaceutical companies that have a very diverse portfolio will be able to make it out of any lulls in the market. Conversely, small and mid-level companies that invest in innovation will be the ones that suffer the most damage.
Disclosure: The author has a position in AbbVie.
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