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    Home > Chemial News > Pharma News > Top 10 drugs that lose patent rights in the U.S. market in 2021

    Top 10 drugs that lose patent rights in the U.S. market in 2021

    Echemi 2021-03-11

    This article summarizes the top 10 drugs that are about to lose patent protection in the U.S. market in 2021. These drugs may be marketed by cheaper generics, which provides opportunities for generic drug manufacturers.


    1. Lucentis


    U.S. sales in 2020: $1.61 billion


    Diseases: age-related wet macular degeneration, macular edema after retinal vein occlusion, diabetic macular edema and diabetic retinopathy


    Generic drugs enter the market: the second half of 2021


    Roche stated in its annual report that “Lucentis’ patent expiration date in the US market is approaching, which may affect the product’s sales in 2021.” Due to the delay or cancellation of treatment for patients due to COVID-19, the drug was brought in the US last year. Sales of 1.61 billion U.S. dollars came in, a 16% decrease from 2019. In November last year, Samsung Bioepis stated that the FDA approved the SB11 biosimilar license application for Lucentis. A Samsung Bioepis spokesperson said the drug will be reviewed within 12 months. In addition to Samsung Biopeis and Biogen may launch generic products in 2021, another potential Lucentis generic drug from Coherus is also expected to submit a Bioeq application to the FDA this year.


    2. Bystolic


    U.S. sales in 2020: undisclosed (2019 sales of $600 million)


    Disease: Hypertension


    Generic drugs enter the market: September 17


    Bystolic, approved for the treatment of high blood pressure, lost the protection of its last patent on December 17 this year. According to the settlement agreement reached by Allergan and numerous generic drug manufacturers in 2013, generic drugs will be able to be launched 3 months (September 17) before the patent expires. According to the Bystolic patent settlement agreement, Actavis, Alkem, Amerigen, Glenmark, Hetero, Indchemie, and Torrent will be licensed to sell their generic drugs, provided that the generic drug products are approved by the FDA. According to agency records, Hetero Labs has received preliminary approval from the FDA for its generic drugs. The drug generated $600 million in revenue for Allergan in the United States in 2019. In addition, the drug is already facing competition from generic drugs in Europe, resulting in a decline in sales.


    3. Vascepa


    U.S. sales in 2020: $598 million


    Diseases: hypertriglyceridemia and cardiovascular disease


    Generic drugs enter the market: November 2020


    Amarin's cardiovascular disease drug Vascepa has made it the most popular product in the biopharmaceutical industry. This drug can significantly reduce the cardiovascular risk of patients with abnormally high triglyceride levels. Amarin's Vascepa has US sales of 598 million U.S. dollars in 2020, an increase of 40% over the previous year. Following the court's decision in March 2020 that the Amarin patent lawsuit was lost and the appeal failed in September, Hikma launched the Vascepa generic drug last November. The listing of generic drugs will seriously threaten Vascepa's sales growth. When Amarin lost its patent protection in the United States, CEO John Thero stated that the company would "vigorously seek available remedies" and seek other regulatory approvals for the drug in China, Europe and other countries or regions.


    4. Northera


    U.S. sales in 2020: $416 million


    Disease: Neurogenic orthostatic hypotension


    Generic drugs enter the market: February 2021


    Lundbeck is facing the loss of patent protection for the neurogenic orthostatic hypotension drug Northera. Lundbeck said in its annual report that the drug was approved in 2014 and is expected to lose its exclusive rights in February 2021. Lundbeck said that even under the influence of the global pandemic of COVID-19, Northera “still achieved solid sales growth and demonstrated development resilience in 2020.” However, this growth is coming to an end. Lundbeck predicts that with multiple imitations in 2021 With the launch of pharmaceuticals, sales will drop significantly by 50%. Last year, Northera received $416 million in revenue in the North American market, an increase of 10% over the previous year, accounting for 14% of the company's total revenue. The listing of generic drugs will pose a huge threat to Lundbeck's 2021 performance.


    5. Narcan


    U.S. sales in 2020: $311 million


    Disease: Opioid overdose


    Generic drugs enter the market: the second half of 2021


    In order to protect Narcan's US$311 million in US sales from generic drugs, Emergent and its partner Opiant Pharmaceuticals filed an appeal, and the Federal Circuit Court of Appeals is likely to rule on the issue in the second half of 2021. Wells Fargo analyst Jacob Hughes and Emergent CEO Bob Kramer said that Teva is "very unlikely" to launch a generic drug before the lawsuit is pending. In addition to confronting Teva, Emergent also tried to stop Perrigo, another Narcan generic drug manufacturer. Last year, Perrigo and Emergent reached a settlement, granting Perrigo a patent license, Perrigo can sell its generic drugs in 2033 or earlier. According to FDA data, if the patent litigation remains successful, Narcan's patent will continue until 2035.


    6. Brovana


    U.S. sales in 2020: approximately $275 million


    Disease: Chronic Obstructive Pulmonary Disease


    Generic drugs enter the market: the second half of 2021


    Sunovion maintenance drug Brovana has been facing competition in the crowded field of chronic obstructive pulmonary disease, but by 2021, the introduction of generic drugs may further intensify market competition. All Brovana patents will expire in 2021, and some generic drug manufacturers have currently received provisional approval from the FDA, including Teva, Cipla and Lupin. GoodRx, a pharmaceutical e-commerce company, believes that it is possible to launch generic generic drugs in September 2021, and OptumRx, a pharmaceutical benefits management company, believes that generic drugs may start in November this year. Brovana was approved by the FDA in 2006. The company has not yet announced its full-year results. Sunovion expects Brovana’s sales in the North American market to be US$275 million in 2020. In addition to generic drugs, the drug also needs to compete for market share with other chronic obstructive pulmonary disease drugs, including GlaxoSmithKline Advair and its generic drugs, Mylan Perforomist, etc.


    7. Sutent


    U.S. sales in 2020: $2.23 million


    Diseases: gastrointestinal stromal tumors, advanced renal cell carcinoma and pancreatic neuroendocrine tumors


    Generic drugs enter the market: August 2021


    Pfizer Sutent was approved in 2006 for the treatment of certain patients with gastrointestinal stromal tumors, advanced renal cell carcinoma (RCC) and certain pancreatic neuroendocrine tumors. Mylan filed a Sutent generic drug application with the FDA in 2010, prompting Pfizer to file a lawsuit against Mylan for alleged patent infringement. After a four-day trial in 2014, the court announced that it would maintain Sutent's patent protection until 2021. Douglas Lankler, Pfizer’s general counsel, said at the time: “The defense of intellectual property rights is critical to Pfizer’s ability to discover and develop innovative new drugs. This is the core of Pfizer’s work.” Although all patents for the drug expire in 2021, So far, no generic drugs have been approved by the FDA. It is worth noting that Glenmark recently launched Sutent generic drugs in India.


    8. Saphris


    U.S. sales in 2020: undisclosed (IQVIA estimates the market size to be 217 million US dollars)


    Disease: Schizophrenia and type I bipolar disorder


    Generic drugs enter the market: December 11, 2020


    AbbVie will likely see a generic product of the antipsychotic Saphris in the US market in 2021. Sabbris was acquired by AbbVie's acquisition of Allergan and is used to treat schizophrenia and type I bipolar disorder. OptumRX reports that Breckenridge, Alembic, and Sigmapharm launched generic drugs of Saphris in mid-December. At present, AbbVie has not announced the sales of Saphris in its financial report, but Alembic quoted IQVIA data to estimate that in the 12 months ending in September 2020, the value of Saphris in the US market is expected to reach 217 million US dollars. .


    9. Amitiza


    U.S. sales in 2020: $180 million


    Diseases: constipation and irritable bowel syndrome


    Generic drugs enter the market: January 4


    Par announced the launch of Amitiza imitation products on January 4 this year. The generic label of Par is similar to that of Amitiza, which is approved for the treatment of chronic idiopathic constipation in adults, irritable bowel syndrome in women with constipation, and constipation caused by opioids.


    Amitiza's patent loss is a difficult time for Mallinckrodt. Faced with "major lawsuits and debt problems," the drug maker filed for bankruptcy protection in October last year. The company said that Mallinckrodt's legal liability could reach "billions of dollars." Before declaring bankruptcy, Mallinckrodt reported that Amitiza generated $90.5 million in revenue in the first half of 2020. If this sales rate continues to be maintained, Amitiza's sales last year may be approximately $180 million.


    10. Feraheme


    U.S. sales in 2020: $150 million


    Disease: Iron deficiency anemia


    Generic drugs enter the market: July 2021


    In November last year, Clovis bought Amag for approximately US$647 million and obtained Feraheme, a drug used to treat iron-deficiency anemia. But before the merger, Amag and generic drug manufacturer Sandoz reached a deal that would allow Sandoz to launch Feraheme generic drugs in July 2021. However, this transaction was reached after Amag reached a settlement with Sandoz in a patent infringement lawsuit in March 2018. The drug did bring Amag US$74 million in revenue in the first half of 2020, but Feraheme’s sales data throughout 2020 have not been announced.

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