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

CompilationFan Dongdong

This article summarizes the top 10 drugs that are about to lose patent protection in the U.

1.

U.

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.

2.

U.

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.

3.

U.

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.

4.

U.

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.

5.

U.

Disease: Opioid overdose

Generic drugs enter the market: the second half of 2021

In order to protect Narcan's US$311 million in 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.

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 benefit 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.
In the first half of 2020, the drug did bring Amag US$74 million in revenue, but Feraheme's sales data throughout 2020 have not been announced.

Reference source: The top 10 drugs losing US exclusivity in 2021