This paper summarizes 10 drugs that are about to lose patent protection in 2021, these drugs may be preempting the market share, which provides opportunities for imitation drug manufacturers.

1, Lucentis

2020 US Sales: $ 1.61 billion

Disease: with age-related wet macular degeneration, macular edema, diabetic macular edema and diabetic retinal lesions after retinal veins

Materials enter the market: in the second half of 2021

Roche said in its annual report, "Lucentis is approaching in the US market, which may affect the sale of the product in 2021." Because COVID-19 leads to patient delays or cancel treatment, the drug is taken in the United States last year. Sales of $ 161 billion, a decrease of 16% over 2019. In November last year, Samsung Bioepis said the FDA approved the application for Lucentis's SB11 biometric drug license. Samsung Bioepis spokesperson said that the drug will be reviewed within 12 months. In addition to Samsung Biopeis and Baijian may be listed in 2021, another potential Lucentis imitation drug from Coherus is also expected to submit BioEQ applications to FDA this year.

2, BYSTOLIC

2020 US Sales: Uneak Open (Sales of $ 600 million in 2019)

Disease: hypertension

Simulation drug enters the market: September 17

BYSTOLICs approved for the treatment of high blood pressure have lost the last patent protection from December 17 this year. According to the reconciliation agreement reached by Erjian and many generic drug manufacturers in 2013, the imitation drug will be able to launch at the 3 month (September 17) before the patent expires. According to the BYSTOLIC Patent Control Agreement, Actavis, Alkem, Amerigen, Glenmark, Hetero, Indchemie, and Torrent will obtain licenses for the sale of their imitation drugs, provided that the imitation drug products have been approved by the FDA. According to the institutional record, HETERO LABS has obtained the preliminary approval of the FDA on its imitation drug. The drug created $ 600 million in income for El Jort in the United States in 2019. In addition, the drug has faced the competition of imitation drugs in Europe, which leads to a decline in sales.

3, Vascepa

2020 US Sales: $ 598 million

Disease: high triglyceride ester ester, cardiovascular disease

Simulation drug enters the market: November 2020

Amarin Cardiovascular Disease VascePA makes it the most popular product of the biopharmaceutical industry, which significantly reduces the cardiovascular risk of patients with abnormal levels of triglycerides. Amarin's VascePA in 2020 is $ 598 million, an increase of 40% from the previous year. Following the March 20th Court Judgment Amarin Patent Licension and after the failure in September, Hikma launched VascePA imitation drugs in November last year. The listing of the imitation drug will seriously threaten the sales growth of VASCEPA. When Amarin lost patent protection in the United States, John Thero, CEO, said the company will "seek the useful remedies" and seek other regulatory approvals related to the drug in China, Europe and other countries or regions.

4, Northera

2020 US Sales: 416 million US dollars

Disease: Neuronic gaseous low blood pressure

Simulation drug enters the market: February 2021

LundBeck is facing the problem of neuronoid gaseous hypotension drug Northera lost patent protection. Lundbeck said in its annual report that the drug was approved in 2014 and is expected to be lost in February 2021. LundBeck said that even if the global pop-up of neogign pneumonia, Northera has achieved robust sales growth in 2020, and showed development toughness. "However, this growth is about to end, Lundbeck is expected, with more than 2021 The launch of pharmaceuticals will drop significantly by 50%. Last year, Northera received $ 416 million in income in the North American market, an increase of 10% over the previous year, accounting for 14% of the company's total revenue, and the listing of generic drugs will make a huge threat to Lundbeck's 2021 performance.

5, Narcan

2020 US Sales: 311 million US dollars

Disease: Excessive absence

Materials enter the market: in the second half of 2021

In order to protect Narcan's $ 311 million in the United States, the Emergent and its partner Opiant Pharmaceuticals have appealed. The Federal Tour Court is likely to ruling this issue in the second half of 2021. BB Kramer, CEO, Fu Dome, said that Bob Kramer, CEO of Emergent, said that the ladder is "very impossible" to "very impossible" before the suspension of the lawsuit. In addition to the confrontation with ladders, Emergent also tries to stop another Narcan's imitation drug manufacturer Perrigo. Last year, Perrigo and Emergent achieved reconciliation, granting Perrigo patented license, Perrigo can sell its imitation drugs in 2033 or earlier. According to FDA data, if patent litigation sustains victory, Narcan's patents will last until 2035.

6, Brovana

2020 US Sales: about $ 275 million

Disease: Chronic obstructive pulmonary disease

Materials enter the market: in the second half of 2021

Sunovion Maintaining Drugs Brovana has been facing competition in the crowded field of chronic obstructive pulmonary disease, but by 2021, the launch of generic drugs may further intensify market competition. All patents from Brovana will expire in 2021, some mammoth manufacturers have currently approved FDA, including ladders, CIPLA and Lupin. The pharmaceutical e-commerce GoodRX believes that it is possible to launch universal imitation drugs in September 2021. The drug welfare management company OptumRX believes that the imitation drug may begin in November this year. In 2006, Brovana was approved by FDA, which has not yet been announced, and Sunov is expected that Brovana's sales revenue in North American market is $ 275 million. In addition to the imitation drug, the drug also needs to compete with other chronic obstructive pulmonary disease drugs, including GlaxoMike Advair and its imitation pharmaceutical, Milan Perforomist, etc.

7, SUTENT

2020 Sales: $ 2.23 million

Disease: gastrointestinal tumor tumors, advanced renal cell carcinoma and pancreatic nerve

Imitation drug enters the market: August 2021

Pfizer Sutent was approved in 2006 to treat some patients with gastrointestinal tumor tumors, advanced renal cell carcinoma (RCC) and certain pancreatic nerve endocrine tumors. Milan has submitted SUTENT imitation drug application to FDA in 2010, prompting Pfizer to litigate the suspected patent infringement of Milan. After the 4-day trial was conducted in 2014, the court announced that SUTENT patent protected until 2021 expired. Pfizer's total legal adviser Douglas Lankler said: "Defending intellectual property is critical to Pfizer discovery and developing innovative new drugs. This is the core of Pfizer's work." Although all patents of the drug have expired in 2021, So far, there is no imitation drug to obtain FDA approval. It is worth noting that Glenmark has launched SUTENT imitation drugs before India.

8, Saphris

2020 US Sales: Unobstructed (IQVIA estimates market size of 217 million US dollars)

Disease: Schizophrenia and I-type double-phase emotional disorder

Materials enter the market: December 11, 2020

Albertvi may see the imitation products of anti-psychotic Sapris in the US market in 2021. Sabbris is Erbevi's acquisition of Al Buching, used to treat schizophrenia and type I double-phase emotional disorders. Optumrx reported that BRECKENRIDGE, ALEMBIC, SIGMAPHARM launched Saphris mi-drug drugs in mid-December. At present, Albeve has not announced Sapris sales in its financial report, but Alembic quoted IQVIA data estimates, as of 12 months in September 2020, the value of Saphris in the US market is expected to reach 217 million US dollars. .

9, Amitiza

2020 US Sales: $ 180 million

Disease: constipation and bowel bowel syndrome

Simulation drug enters the market: January 4

Par announced on January 4 this year to launch the Amitiza imitation product. Par's imitation drug labels are similar to Amitiza, and Amitiza is approved for the treatment of chronic idiopathic constipation, female constipation intestinal syndrome, as well as constipation caused by an absence of absence. Amitiza's patented losses are tough times for MallInckrodt. Due to "major litigation and debt problems", this manufacturer has applied for bankruptcy protection in October last year. The company said that the legal responsibility assumed by MallInckrodt may reach "billions of dollars." Before declaring bankruptcy, MallInckrodt reported that Amitiza created $ 90.5 million in income in the first half of 2020. If you continue to keep this sales speed, Amitiza's last year's sales may be about $ 180 million.

10, Feraheme

2020 US Sales: $ 150 million

Disease: Iron deficiency anemia

Genetic drugs enter the market: July 2021

In November last year, CLOVIS acquired AMAG at approximately $ 647 million in prices to obtain drug feraheme for the treatment of iron deficiency anemia. But before the merger, Amag and the imitation drug manufacturer Sandoz reached a transaction, allowing Sandoz to launch feraheme imitation drugs in July 2021. However, this transaction is reached after Amag's patent infringement in Patent infringement in March 2018. In the first half of 2020, the medicine did brought $ 74 million in income for Amag, but FraraHeme sold data throughout 2020 did not announce.

Reference Source: The top 10 Drugs Losing U.S. Exclusive In 2021

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