Losing the patent exclusivity period, these drugs will face generic competition in 2022!

Previously, foreign media FiercePharma announced 10 drugs whose patents will expire in the US market in 2022, including Revlimid, Lucentis, Vimpat, Alimta,

Figure 1 Top 10 U.

Drug: Revlimid

Company: BMS

Indication: multiple myeloma

2021 U.

Revlimid is a typical case of the new use of old drugs.

Drug: Lucentis

Company: Roche

Indications: Wet age-related macular degeneration (AMD)

2021 U.

Wet age-related macular degeneration (AMD) is a degenerative macular disease, which is one of the main causes of blindness in people over 50 years old in developed countries, and has the characteristics of rapid development, poor prognosis and great harm

Drug: Vimpat

Company: UCB

Indications: partial seizures

2021 U.

Epilepsy is one of the most common chronic neurological diseases in the world.

Drug: Alimta

Company: Eli Lilly

Indications: malignant pleural mesothelioma and non-squamous non-small cell lung cancer

2021 U.

Lung cancer is the leading cause of cancer death in the world, killing more people each year from lung cancer than colorectal, breast and prostate cancers combined

Drug: Restasis

Company: AbbVie

Indications: Ocular inflammation associated with keratoconjunctivitis sicca

2021 U.

Keratoconjunctivitis sicca is a relatively common disease and a high-incidence disease.
It may cause dry eyes, dry mouth and burning eyes in the early stage of the disease.
If reasonable treatment is not paid attention to, it may also affect the patient's lung health.
It can even cause vasculitis and Sjogren's syndrome
.
Restasis is a drug that was listed in 2003 and originally belonged to Allergan.
In May 2020, AbbVie announced the completion of the acquisition of Allergan for $63 billion, and the drug was also included in the bag
.
Restasis’s original U.
S.
patent expired in 2014.
In 2013, the FDA opened the door to generic drugs.
Allergan appealed to the U.
S.
Patent Office and obtained an approval to extend the patent for 10 years
.
In early February, the FDA approved Restasis' first generic drug, Mylan's cyclosporine ophthalmic emulsion 0.
05%, and EvercoreISI said that before Mylan's breakthrough, nine generic manufacturers were Their Restasis generics filed for approval, including Akorn, Amneal, Teva and Pfizer's InnoPharma
.
Sales of Restasis have plateaued since the drug peaked in 2017, when it generated $1.
41 billion
.
In those days, it was thought that the treatment would continue to grow its sales, surpassing $2 billion by 2021
.
But brand competition from Novartis' Xiidra has forced Restasis to cut prices and reduce its demand
.
Sales slumped all the way to $787 million in 2020, when the pandemic played a major role in the recession, but U.
S.
revenue rebounded to $1.
23 billion in 2021
.
Now that generic drugs are on the market one after another, it is not clear what kind of competitive landscape will be formed
.

Drug: Velcade

Company: Takeda

Indications: Multiple myeloma and mantle cell lymphoma

2021 U.
S.
sales: $920 million

Generic drug market entry: March 2022

Multiple myeloma (MM) is a malignant plasma cell disease that accounts for about 10% of all hematological malignancies, and its mortality rate accounts for about 20% of deaths from hematological malignancies
.
Mantle cell lymphoma (MCL), which accounts for 6% of all non-Hodgkin lymphomas (NHL), is a blood cancer that is clinically considered an aggressive cancer that can grow and spread rapidly
.
Velcade was jointly developed by Takeda and Johnson & Johnson, with Takeda responsible for commercializing the drug in the United States
.
Takeda scored a major victory in defending the drug's patents in 2017, extending the drug's patent protection until 2022
.
Even after Fresenius Kabi launched an injectable version of bortezomib in 2018, Takeda's drug has been a big hit, with $920 million in U.
S.
sales in 2021
.
But its U.
S.
profits are drawing to a close, and many generic drug companies are lining up to enter Velcade's big U.
S.
market, according to FDA records, Novartis' Sandoz, AccordHealthcare, Fresenius Kabi Fresenius Kabi and others have already received preliminary generic drug approvals
.
In fact, Takeda has been gearing up for generic drug launch day since its winning patent in 2017 was extended, and is now banking on Velcade's follow-up oral drug Ninlaro to make up for what Velcade has suffered from generic competition
.

Drug: Vasostrict

Company: Endo International

Indications: Diabetes insipidus

2021 U.
S.
sales: $901 million

Generic drug market entry: March 2022

Diabetes insipidus is a group of clinical syndromes caused by hypothalamic antidiuretic hormone, insufficient arginine vasopressin synthesis and secretion, or defective renal response to arginine vasopressin, or excessive arginine vasopressin degradation.
Sign, Vasostrict is the first FDA-approved vasopressin injection
.

Over the past three years, Vasostrict accounted for 30%, 27%, and 18% of Endo's net revenue in 2021, 2020, and 2019, respectively, earning $901 million in 2021, making it the company's best-selling drug
.
In January, Eagle announced that it would launch a generic version of Vasostrict in the U.
S.
market with 180-day exclusive marketing rights.
Eagle's generic version was approved by the FDA in December last year
.
Since Eagle launched generics, other generics are coming to market, and Endo expects the segment to face increased competition in the future and sales to decline rapidly
.
While the era of Vasostrict's captive market is over, Vasostrict has quickly seized this opportunity as the drug has recently emerged as a key treatment option in critical care for COVID-19, which is one of the reasons it became the company's best-selling drug in 2021
.
But competition is inevitable.
In order to offset the market squeeze effect of Vasostrict generic drugs, Endo is pinning its hopes on Dupuytren contracture treatment Xiaflex and "cellulite" injection therapy Qwo.
Xiaflex achieved $432 million in revenue in 2021, compared with July 2020.
Qwo, approved last month, is the first FDA-approved injection therapy for cellulite
.

Drug: Abraxane

Company: BMS

Indications: Breast cancer, non-small cell lung cancer, pancreatic cancer

2021 U.
S.
sales: $898 million

Generic drug market entry: March 2022

Abraxane is one of the most widely used chemotherapeutic drugs, which can be used for first- and second-line treatment of breast cancer, non-small cell and pancreatic cancer.
BMS-Celgene belongs to the original drug company of the drug
.
One of BMS' blockbuster drugs, Abraxane generated about $1.
18 billion in revenue in 2021, down about 5% from $1.
25 billion in 2020
.
In the U.
S.
, sales of the drug fell to $898 million last year
.
The company expects the addition of generics to cut its revenue by nearly half by the end of March
.
According to FDA records, Teva, Hikma and Fresenius Kabi are among the manufacturers of approved Abraxane generics, and there are also Abraxane generics on the European market
.
BMS faces two major losses this year, the end of Abraxane and Revlimid's exclusivity in the U.
S.
market
.
The company expects global sales to reach $47 billion in 2022, with about $10.
5 billion of that coming from Abraxane and Revlimid
.
However, BMS said Revlimid will carry most of the heavy lifting, with Abraxane expected to contribute only about $500 million
.
Another story of Abraxane that has attracted much attention from the outside world is the "breakup" storm-BMS wants to unilaterally terminate the cooperation with BeiGene
.
In 2017, BeiGene signed a deal with CelgeneLogistics Sarl, which is now a subsidiary of BMS after the acquisition
.
The partnership deal at the time was based on a licensing and supply agreement under which BMS granted BeiGene exclusive rights to distribute and market Abraxane, Revlimid and Vidaza in mainland China
.
In March 2020, NMPA found that some of Abraxane's key production facilities did not meet the basic requirements of China's drug production quality management, and there were problems such as inadequate aseptic control measures in the production process.
Therefore, the import, sales and use of Abraxane in China were suspended according to law.

.
In October 2021, BeiGene issued an announcement stating that BMS-Celgene, a wholly-owned subsidiary of BMS, sent a notice to it that it would terminate the agreement related to Abraxane
.
The move was opposed by BeiGene, which plans to vigorously defend BMS-Celgene's claimed termination
.
Story after story, if you want to know what will happen next, please listen to the next time
.

Drug: Pradaxa

Company: Boehringer Ingelheim

Indications: atrial fibrillation, deep vein thrombosis, pulmonary embolism

2021 U.
S.
sales: $550 million

Generic drug market entry: June 2022

After gaining FDA approval in 2010, Pradaxa is slowly approaching the end of its market exclusivity period
.
According to FDA records, the generic drugs of HeteroLabs and AlkemLabs have been approved, and they will only be available after the Pradaxa patent expires.
Preliminary FDA approval
.
Earlier, some experts said that Pradaxa could face generic competition from September 2021, suggesting that the drug's patents expire later than some market watchers expected
.
Boehringer didn't break out half-year sales for the drug, nor for full-year 2021
.
However, in 2020, the company said the drug generated 1.
49 billion euros, "slightly lower than the previous year's results"
.
Still, the drug remains one of Boehringer Ingelheim's strongest revenue contributors, estimating the U.
S.
market for Pradaxa to be $550 million in 2021 when Glenmark receives preliminary FDA approval for its generic version in late 2020
.
In response to a question about the company's expectations for generics, a Boehringer spokesman said it "cannot comment on the approval of another company's product," and "while we can't talk about the specifics of what other companies are developing or launching, But we think it's important for patients to have safe and effective treatment options, including Pradaxa,"

Drug: Combigan

Company: AbbVie

Indications: Glaucoma

2021 U.
S.
sales: $373 million

Generic drug market entry: January 2022

Glaucoma is a very dangerous eye disease caused by elevated intraocular pressure.
High intraocular pressure can cause irreversible damage to various tissues of the eye and vision.
If not treated in time, it may lead to blindness
.
After AbbVie acquired Allergan in 2020, it not only harvested a series of blockbuster drugs, but also acquired two ophthalmic drugs, Restasis and Combigan
.
Combigan was approved by the FDA as early as 2007 and is the TOP-level glaucoma brand in the United States, with sales of $373 million in key markets in 2021
.
In the near term, both ophthalmic drugs will face a patent cliff
.
On January 19 this year, Apotex said it launched the first generic drug authorized by Combigan in the United States
.
In addition, Sandoz, Akorn, and HiTechPharma have all received preliminary FDA approval for generic Combigan
.
For AbbVie, though, the loss of about $400 million in U.
S.
sales isn't the company's primary concern
.
Next year, the company’s patent exclusivity for the blockbuster immune drug Humira expires.
Since its launch, Humira has brought in more than $170 billion in revenue for AbbVie.
In 2021, Humira’s global sales will exceed $20 billion for the first time.
BoVie has been working hard to defend Humira's patent rights in recent years, but the drug's patent in the US market has basically stopped in 2023.
It is expected that at least 9 biosimilars will enter by then to divide up the market share
.
To fill that revenue gap, AbbVie is counting on the newly launched Skyrizi and Rinvoq to bring in $15 billion by 2025
.