The top 10 drugs losing U.S. exclusivity in 2021

Medicines from Roche, Pfizer, AbbVie and more are slated to lose U.S. market exclusivity this year.

As drugmakers respond to the COVID-19 pandemic by developing vaccines and therapeutics, many of them are losing patent protection on older—and once lucrative—medicines. Each year, many of the pharmaceutical industry’s stalwart products lose their exclusive hold on the market, offering an opportunity for generics makers to seize share with cheaper copycats. 

This year’s expected losses of U.S. exclusivity include the Roche macular degeneration blockbuster Lucentis, two medicines from AbbVie and a Pfizer cancer drug. 

Not all of the products are guaranteed to face generic competition in 2021. Some may dodge copycats due to developments in court, regulatory setbacks for generics companies or other unforeseen events. And some are already facing generic rivals. But this list represents Fierce Pharma’s best attempt at identifying the top medicines, ranked by U.S. sales in 2020, that are likely to face new generics or biosimilars this year.

RELATED: After win at patent office, Bristol Myers inks Revlimid deal with Dr. Reddy's 

While this year's list only features one U.S. blockbuster, the drug industry and its investors are bracing for some major patent losses in the coming years. Bristol Myers Squibb’s blood cancer med Revlimid will face limited generics sometime after March 2022, for example, under a patent settlement between the drug giant and Dr. Reddy’s Laboratories. BMS picked up the drug, which generated $12.1 billion in 2020, in its Celgene megamerger. 

After that, AbbVie’s immunology giant Humira, the world’s bestselling medicine, will face staggered biosimilar launches throughout 2023. AbbVie’s Humira defense has generated significant pushback from critics, who have argued that the company created a “patent thicket” that was impossible for biosimilar makers to navigate. AbbVie’s CEO has said the company thought it struck a “reasonable balance” with its patent deals, even though they might not be “popular.” 

RELATED: AbbVie's Humira defense may keep prices high, but it's still legal, judge rules 

Some companies are managing to keep hold of their biggest hits. Novartis is still hanging onto market exclusivity for big-selling meds Gilenya for multiple sclerosis and Sandostatin LAR for some patients with metastatic carcinoid tumors. Regeneron’s macular degeneration drug Eylea could face biosims in the years to come, but it’s not clear yet when those will launch. AstraZeneca just scored a patent win on Symbicort that could keep copycats at bay until 2023.

This report is based on information from numerous sources, including lists of potential generic launches from OptumRxGoodRxGreyB, and Corporate Pharmacy Services, plus company filings, conference calls with analysts, FDA records and more. We hope you enjoy, and please be in touch with any feedback.  -- Eric Sagonowsky (email)

The top 10 drugs losing U.S. exclusivity in 2021