• Staff

Pharmaceutical Drugs Losing U.S. Exclusivity in 2021

Updated: Mar 14, 2021

As pharma companies respond to the Covid-19 pandemic by producing vaccines and therapeutics, a lot of them are losing patent protection on older – and once lucrative – drugs. Each year, a number of the pharmaceutical industry’s top products lose their exclusive grip on the market, offering a chance for generics makers to seize share with more affordable copycats.

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

However, not all of the products are guaranteed to face generic rivalry this year. A number of them may dodge copycats as a result of legal filings, regulatory setbacks for generics firms or other unanticipated circumstances. And some are already facing generic competitors. This exclusive list represents our calculated attempt at identifying the top drugs, ranked by U.S. sales in 2020, that have potentials of facing new generics or biosimilars in 2021.

Our report is based on information from several sources, including lists of likely generic launches from GreyB, GoodRx, OptumRx and Corporate Pharmacy Services, in addition to company filings, analysis from fiercepharma and FDA records.

Enjoy our list:

1. Lucentis.

2020 U.S. sales: $1.61 billion.

Disease: Wet age-related macular degeneration, macular oedema following retinal vein occlusion, diabetic macular oedema and diabetic retinopathy.

Likely generic entry date: Second-half of 2021.

Roche’s wet age-related macular degeneration (AMD) drug Lucentis faced new rivalry when Novartis launched Beovu in October 2019. But this year, the entire class of drugs could face a distinctly new challenge: biosimilars. In November, 2020, Samsung Bioepis disclosed that the FDA said yes to reviewing its biologics license application for SB11, a biosim referencing Lucentis. The approval “brings us a step closer to our goal of being able to offer affordable treatment options for people with retinal vascular disorders,” Samsung Bioepis executive Hee Kyung Kim remarked at the time. The drug is expected to be reviewed in a standard 12-month timeline.

Biogen owns a 49.9% stake in Samsung Bioepis and will commercialized the biosimilar in the U.S. and other major markets, the company disclosed in a recent investor presentation. Biogen will also be responsible for marketing a biosimilar aimed at Regeneron’s Eylea, though that’s unlikely to take place in 2021.

2. Bystolic

2020 U.S. sales: Undisclosed (2019 sales $600 million)

Disease: High blood pressure.

Likely generic entry date: September 17, 2021.

When AbbVie signed its Allergan mega-deal in 2019, the company targeted shoring up its post-Humira future. While Humira’s loss is weighing over the pharma company, an Allergan medicine the drugmaker picked up in that deal is set to rival generics this fall.

Bystolic, approved as a treatment for high blood pressure, loses protection from its last patent on December 17, under a 2013 resolution with many generics players, copycats will be able to launch three months before that patent expiry, on September 17. Forest Laboratories, one of the main developers of Bystolic, won the patent deal prior to a series of M&A deals that brought the drug to AbbVie.

Under the Bystolic patent settlement, Actavis, Alkem, Amerigen, Glenmark, Hetero, Indchemie and Torrent will be offered licenses to market their generics – provided their copycats can score FDA approvals. Hetero Labs has already won a tentative FDA approval for its generic, based on agency records.

One likely issue for the generic landscape? Direct buyers have sued, alleging that those settlements violated antitrust laws. It is uncertain how the litigation could impact Bystolic generic launches, but the buyers are targeting more generic access, not less.

For pharma giant AbbVie, losing a share of Bystolic’s yearly U.S. dales to generic isn’t a primary concern. In fact, the drugmaker didn’t break out Bystolic sales in its 2020 annual filing with the SEC, which remarked that “no single patent, license, trademark,” except for those related to Humira, are “material in relation to the company’s business as a whole.”

AbbVie pulled in $45.8 billion in revenue in 2020, but its upcoming Humira loss of exclusivity in the U.S. has raised concerns among investors and analysts. Humira recorded $16.1 billion in 2020.

3. Vascepa.

2020 U.S. sales: $598 million.

Disease: Hypertriglyceridemia and cardiovascular disease.

Likely generic entry date: November, 2020.

Amarin’s heart drug Vascepa made it one of the premium players in the Biopharma industry. Then the med, when combined with statins, recorded impressive data in 2018 showing an outstanding reduction of cardiovascular risks in patients with unusually high triglyceride levels.

Amarin executives figured the firm could dramatically up sales if the FDA included the data in the label, and in 2019, the agency did just that. But a 2020 patent loss in the court – and now a generic launch – pose problems for the drugmaker in 2021.

Amarin’s Vascepa recorded $598 million in 2020 U.S. sales, a 40% boost from the previous year. On the back of a patent loss for Amarin in March 2020 court decision and an unsuccessful appeal in September, Hikma launched its generic in November. The launch will likely frustrate Amarin’s growth plans for Vascepa, which achieved its original FDA approval in 2012.

Following the generic launch, Cantor Fitzgerald analyst Louise Chen disclosed to clients in a note in February that her team has heard “some retail pharmacy chains have slowed filling branded Vascepa [prescriptions] because a generic is listed, even though they don’t have the supply of the generic.”

Amarin filed a patent lawsuit against Hikma in late November and is “working to educate these pharmacies regarding both the supply shortage and the limited label of the generic product,” Chen wrote.

Hikma’s generic is only approved as an adjunct to diet to lower triglyceride levels in adult patients with severe hypertriglyceridemia. According to OptumRx, this doesn’t include the cardiovascular risk reduction data. Amarin disclosed that Hikma’s “skinny label” for its generic threatens about $40 million in Vascepa’s yearly sales at 2020 prescription levels.

4. Northera

2020 U.S. sales: $416 million.

Disease: Neurogenic orthostatic hypotension.

Likely generic entry date: February 2021.

Amid its efforts to boost sales of new migraine prevention medicine Vyepti, Lundbeck is facing fears about the fate of its neurogenic orthostatic hypotension drug Northera. The med, approved in 2014, was anticipated to lose exclusivity in February, 201 Lundbeck disclosed in its yearly report.

Northera is approved as treatment for dizziness and lightheadedness, or the “feeling that you’re about to blackout” in adult patients with symptomatic neurogenic orthostatic hypotension. Despite the pandemic in 2020, the drug “delivered solid growth in sales and has shown resiliency,” Lundbeck stated.

But that growth is being threatened. Lundbeck anticipates sales to reduce by 50% as multiple generics launch in 2021.

In 2020, Northera recorded $416 million in North America, a 10% improvement from the previous year. That was 14% of the firm’s total revenue, making the generics a significant threat to the drugmaker’s 2021 performance.

Meanwhile, Lundbeck has earmarked resources over the last year to the launch of its new migraine-prevention medicine, Vyepti. The drug was launched right as the Covid-19 pandemic gained steam globally, bringing about another challenge as the company targets growth in market share in a competitive class.

Vyepti is entering the CGRP class of migraine drugs, which is led by Amgen and Eli Lilly, but Lundbeck is banking on the drug’s quarterly dosing schedule and efficacy to attract a modest share of patients. The company anticipates “an acceleration” of Vyepti sales this year.

5. Narcan.

2020 U.S. sales: $311 million.

Disease: Opioid overdose.

Likely generic entry date: Second-half of 2021.

It’s usually impossible to accurately predict when generic versions of premier branded drugs will enter the market. But the signs point to a potential launch of copycats to Emergent Bisolutions’ opioid-overdose med, Narcan, in 2021.

Generics heavyweight Teva won an FDA approval for its Narcan generic back in 2019, but the drug’s patent protections have halted the copycat’s entry into the market since then. Teva won in court last June, when a New Jersey federal judge ruled that claims on many Narcan patents were illegal.

Aiming to protect Narcan’s $311 million in U.S. sales, Emergent and its collaborator Opiant Pharmaceuticals appealed, and the Court of Appeals for the Federal Circuit will potentially rule on the case in the second half of 2021. In a statement released in January following a call with Emergent’s CEO Bob Kramer, Wells Fargo analyst Jacob Hughes wrote that the top official believes it’s “high unlikely” Teva will launch a generic while the litigation is in the offing.

Yet, the Wells Fargo team predicts that Emergent will lose its appeal “based on input from two patent experts,” Hughes wrote.

Emergent’s execs appear to be realistic about their odds of prevailing in the patent tussle. On a mid-February conference call with industry analysts, Kramer remarked that Emergent expects “there will be a generic entrant as soon as the appeal process is complete.” However, the drugmaker is “mounting a strong appeal and we are making every effort to turn that back in our favor,” CFO Rich Lindahl confirmed.

Emergent’s financial postulation assumes Narcan won’t face generic rivalry prior to the appeals ruling. But the firm does anticipate some generic competition this year.