Top 10 patent expired drugs in 2021: 3 have entered China involving ranibizumab and sunitinib

Many drugmakers are losing patent protection for long-established and once lucrative drugs.

This year, it is expected that Roche’s macular degeneration drug Lucentis (Ranibizumab), two AbbVie drugs and one of Pfizer’s anti-cancer drugs will lose their monopoly rights in the United States this year.

However, not all products will face generic competition in 2021.

In the next two years, two tens of billions of US dollars blockbuster drugs will face patent expiration, including Xinji's anti-tumor drug Revlimid (lenalidomide), which will face generic drugs after March 2022 Competition, the drug will generate 12.

The following is Fierce Pharma's ranking of U.

01 Lucentis (Ranibizumab)

U.

Indications: Wet age-related macular degeneration, macular edema after retinal vein occlusion, diabetic macular edema and diabetic retinopathy

Potential generic entry: the second half of 2021

When Novartis launched Beovu in October 2019, Roche's wet age-related macular degeneration (AMD) drug ranibizumab faced new competition.

In November last year, Samsung Bioepis stated that the FDA agreed to review its license application for the biosimilar drug SB11 for ranibizumab.

The company stated in a recent investor presentation that Biogen owns 49.

The drug generated 1.

It is reported that ranibizumab was approved for listing in China in 2012, and currently only the original research drug is on the market.

02 Bystolic (nebivolol hydrochloride)

Sales in the U.

Indications: Hypertension

Potential generic drug entry: September 17, 2021

When AbbVie signed its Allergan large-scale acquisition plan in 2019, the company tried to consolidate its future after Xiumira.

According to the patent settlement agreement, Actavis, Alkem, Amerigen, Glenmark, Hetero, Indchemie and Torrent will be licensed to sell their generic drugs, provided they can win FDA approval.

However, in the face of the threat of the expiration of the super single product Xiu Mei Le, AbbVie did not pay much attention to the drug.

03 Vascepa

2020 sales in the U.

Indications: hypertriglyceridemia and cardiovascular disease

Potential generic drug entry: November 2020

Amarin's heart drug Vascepa has made it one of the hottest players in the biopharmaceutical industry.
When the drug is used in combination with statins, it can significantly reduce the cardiovascular risk of patients with abnormally high triglyceride levels.

Vascepa was approved by the FDA in 2012 for hypertriglyceridemia.
The company’s official data shows that Vascepa’s U.
S.
sales in 2020 were $598 million, an increase of 40% over the previous year.
Following the court's decision in March 2020 that the Amarin patent was lost and the appeal failed in September, Hikma launched its generic drug in November.
This launch will threaten Amarin's Vascepa growth plan.
However, Amarin did not give up the lawsuit and filed a patent lawsuit against Hikma in late November last year.

Currently, Hikma's generic drugs are only approved as an auxiliary component of the diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia.
Amarin claims that the "slimming label" of Hikma's generic drugs threatens Vascepa's annual sales of approximately US$40 million at the level of prescription drugs in 2020.

It is worth noting that this medicine officially landed in the Lecheng International Medical Tourism Pilot Zone in Boao, Hainan on January 17 this year, becoming the first cardiovascular drug to land in the Lecheng Pilot Zone.

04 Northera (Drxidopa)

2020 sales in the U.
S.
: $416 million

Indications: Neurogenic orthostatic hypotension

Potential generic entry: February 2021

It is reported that Droxidopa developed by Lundbeck was approved by the FDA in 2014 for the treatment of dizziness in adult patients with symptomatic neurogenic orthostatic hypotension.
Lundbeck said that despite the impact of the pandemic, the drug has achieved solid growth (a 10% year-on-year increase) and has shown resilience.
However, the company expects that with the expiration of the patent in February 2021 and the launch of a variety of generic drugs, the sales of droxydopa will drop by 50%.

It is worth noting that the drug sales accounted for 14% of the company's total revenue, so generic drugs pose a huge threat to the company's performance.
At the same time, Lundbeck launched a new migraine prevention drug Vyepti last year, but this new drug is entering the CGRP category of migraine drugs led by Amgen and Eli Lilly.
Although the challenge is not small, the company Vyepti's sales are expected to "accelerate growth" this year.

05 Narcan (Allyloxymorphone Hydrochloride)

2020 sales in the U.
S.
: $311 million

Indications: Opioid overdose

Potential generic entry: the second half of 2021

There are indications that in 2021, imitators may begin to imitate Emergent Biosolutions' drug allyloxymorphone hydrochloride for the treatment of opioid overdose.

Generic drug giant Teva was nominated by the FDA for its generic drug of allyloxymorphone hydrochloride as early as 2019, but the patent protection of the drug prevented generic drugs from being marketed.
In June last year, a New Jersey federal judge ruled that Teva won and invalidated multiple patent claims for allyloxymorphone hydrochloride.
In order to protect the US$311 million in sales of allyloxymorphone hydrochloride in the United States, 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 believes that it is "very unlikely" for Teva to launch a generic drug while the lawsuit is pending.
At the same time, emergency medical personnel believe that the opioid epidemic is "increasing, not less.
" Emergent CEO Kramer also admitted that the company must continue to provide its medicines to those in need.

Emergent acquired allyloxymorphone hydrochloride through its acquisition of Adapt Pharma in 2018.
The drug's sales in 2020 were 311 million U.
S.
dollars, an increase of 11% from 2019.
The company expects sales of this product to be between US$305 million and US$325 million this year.

In addition to fighting Teva, Emergent also tried to stop Perrigo, a potential imitator.
Last year, Perrigo and Emergent reached a settlement, granting Perrigo a license to sell its generic drugs in 2033 or earlier, depending on how the Teva lawsuit is conducted.
According to the data in the FDA Orange Book, if it persists, Emergent's patent will last until 2035.

Domestically, Yichang Renfu submitted an application for clinical registration of hydromorphone hydrochloride sustained-release tablets on February 8, 2018 and was accepted.

06 Brovana (arformoterol tartrate)

U.
S.
sales forecast for 2020: approximately $275 million

Indications: chronic obstructive pulmonary disease

Potential generic entry: the second half of 2021

Sunovion's COPD maintenance drug arformoterol tartrate has been fighting competition in this crowded field, but competition in 2021 may be intensified by generic drugs.

All patents for arformoterol tartrate will expire in 2021, and several generic drug manufacturers have received preliminary approval from the FDA.
According to the FDA, these drugs include Teva, Cipra, and Lupin.

GoodRx believes that generic drugs may be launched in September 2021, while OptumRx said that generic drug competition may begin in November.

Although there are many competitors in the crowded COPD market, Sunovion's parent company Sumitomo Pharmaceuticals expects that by 2020, arformoterol tartrate in North America will reach US$275 million in revenue.
The company has not yet announced its full-year results.
In 2006, Arformoterol tartrate was approved by the FDA and has been operating in a highly competitive market for many years.

It is understood that the domestic original research drug has not yet been approved in China, and Chia Tai Tianqing was the first to apply for the listing of generic drugs on November 29, 2019.

07 sunitinib

2020 U.
S.
sales: approximately 223 million US dollars

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

Potential generic entry: August 2021

Sunitinib was approved in 2006 for the treatment of certain patients with gastrointestinal stromal tumors, advanced renal cell carcinoma (RCC) and certain pancreatic neuroendocrine tumors.
According to FDA records, all patents for the drug will expire in 2021, which makes it vulnerable to attacks by generic competitors, although no generic drugs have been approved by the FDA so far.

Glenmark has just launched a generic version of sunitinib in India.
In 2010, Mylan submitted a generic version of sunitinib to the FDA, leading Pfizer to sue it for patent infringement.
In 2014, after four days of trial, the court supported the 2021 patents of sunitinib.

Many years after the patent dispute occurred, Mylan and Pfizer joined forces to merge Pfizer Proton and Mylan to form a new company, Viatris.
The transaction was completed in November last year.

Most of sunitinib's current sales come from emerging markets.
In 2020, sales in this region were US$261 million, while revenue in the United States was US$223 million, a year-on-year decrease of 21%.
The drug reached its peak in 2012 , About 1.
236 billion US dollars.

In January 2020, the "Sunitinib Malate Capsules (12.
5mg)" developed by CSPC has been issued a drug registration approval document by the National Medical Products Administration of China, making it the first domestic generic drug of this variety to be approved.
The second domestically produced sunitinib (developed by Hausen Pharmaceuticals) was also changed to the approval status at the end of April last year.

08 Saphris (asenapine)

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

Indications: schizophrenia and type I bipolar disorder

Potential generic drug entry: December 11, 2020

In addition to facing the generic competition of the blood pressure drug Bystolic, whose patent expired this year, and the upcoming loss of the exclusive right to operate the US$16 billion annual Humira, AbbVie will also see its antipsychotic drug Asena in 2021.
Flat generic drugs.

This drug is also derived from AbbVie's acquisition of Allergan.
According to OptumRX, Breckenridge, Alembic and Sigmapharm launched their generic drugs in mid-December.
As one of the first generic drugs approved for approval, Alembic stated that it and other generic drug companies are eligible for 180 days of shared generic drug exclusivity.

AbbVie did not disclose the sales of the drug in its financial report, but Alembic quoted IQVIA data to estimate that in the 12 months ending in September 2020, the market sales of asenapine were US$217 million.

09 Amitiza (lubiprostone)

2020 sales in the U.
S.
: approximately $180 million (estimated)

Indications: constipation and irritable bowel syndrome

Potential generic drug entry: January 4, 2021

The troubled pharmaceutical company Mallinckrodt is once again in another dilemma due to opioid and Acthar lawsuits, but its drug lubiprostone for treating constipation and irritable bowel syndrome is usually not the focus of everyone's attention.
This year, as the company faces bankruptcy proceedings, the drug has succumbed to generic drugs.

According to an agreement reached by Sucampo, the former owner of lubiprostone, Par Pharmaceutical will launch its authorized generic drug in the United States in early 2021.
It is reported that Mallinckrodt acquired Sucampo in 2018.
Par announced the launch of its generic drug products on January 4.

Before declaring bankruptcy, Mallinckrodt reported that lubiprostone had revenues of US$90.
5 million in the first half of 2020.
If the company maintains this sales rate, Lubiprostone's sales last year could reach about $180 million.

10 Feraheme

2020 sales in the U.
S.
: (estimated) approximately $150 million

Indications: Iron deficiency anemia

Potential generic entry: July 2021

In November last year, the Clovis Group acquired Amag Pharmaceuticals and included Feraheme, a drug used to treat iron deficiency anemia.
But before the merger, Amag and Sandoz signed an agreement that is expected to enable Sandoz to launch a generic version of Feraheme this summer.

This was derived from the settlement between Amag and Sandoz in a patent infringement lawsuit in March 2018.
The settlement agreement allows Sandoz to launch the generic Feraheme in July 2021, provided that the company obtains FDA approval before a "specific date.
" The date has not yet been disclosed, but Sandoz received FDA approval for a generic drug in January.

The settlement agreement also includes a provision that Sandoz can "start in advance under certain circumstances that are customary in settlement agreements of this nature.
" The manufacturer of the generic drug agreed to pay Amag royalties until the last patent for the drug expires.
According to FDA records, the last patent expires on June 30, 2023.

If Sandoz’s approval comes too late under the non-disclosure agreement, then the agreement includes a clause that allows Sandoz to launch authorized generic drugs provided by Amag in July 2022.

The imminent loss of Feraheme is one of a series of weaknesses that makes Amag easily acquired.
The company underwent a strategic evaluation due to the departure of an activist investor and a CEO, and FDA experts recommended that the agency withdraw the premature drug Makena from the market.
In October of this year, the FDA stated that it is considering removing Makena from the market, although the approval and labelling have not yet changed.

In November 2020, Covis acquired Amag for $647 million.
Although the drug generated $74 million in revenue for Amag in the first half of 2020, Feraheme's sales data are no longer subject to public disclosure restrictions.
This will bring its revenue for the full year of 2020 to around US$150 million.

The above content is compiled from fiercepharma website