Countdown to patent expiration: patent cliffs 1-5 for these drugs in the next ten years (on)

1.
Humira (Adalimumab, Adalimumab)

1.
Humira (Adalimumab, Adalimumab)

Original research company : AbbVie

Original Research Company

Mechanism of action : TNFα inhibitor

Mechanism

Global approved indications: ulcerative colitis; uveitis; psoriasis; Crohn's disease in children; hidradenitis suppurativa; rheumatoid arthritis; ankylosing spondylitis; Crohn's disease; psoriatic arthritis; Juvenile rheumatoid arthritis; plaque psoriasis

Global approved indications:

Approved indications in China: children's Crohn's disease; rheumatoid arthritis; ankylosing spondylitis
.

Approved indications in China:

2020 sales: $19.
8 billion

2020 sales:

Note: The histogram unit is millions of U.
S.
dollars

Note: The histogram unit is millions of U.
S.
dollars

Key patent expiration: 2023

Key patents expire:

2019 is the first year that Xiu Meile faces competition from European biosimilar drugs.
Its sales fell by 3.
9% in that year and its global sales fell by as much as 31%.
However, the situation has improved in 2020, and its sales There is growth every quarter, and its Active indications even include new coronavirus pneumonia.
It is the best drug sold in 2020
.

However, there are some controversies about the price of Medicine King Xiu Mei Le.
In a recent US Congress investigation report, it was revealed that AbbVie and Abbott Laboratories had repeatedly adjusted prices, pushing the price of Xiu Mei Le up ten times the original price.
The cost of the 40 mg syringe has been increased to nearly US$3.
000
.

In 2017, AbbVie and Amgen signed the first Humira biosimilar drug settlement agreement.
By 2023, it will face the first batch of U.
S.
generic drugs competition.
In 2020, the U.
S.
market will contribute 16.
1 billion to Humira Dollar sales
.

In addition to Amgen, Boehringer Ingelheim, Pfizer, Samsung Bioepis, Mylan, Sandoz and other companies have also joined the generic drug team

2.
Keytruda (Pembrolizumab, Pembrolizumab)

2.
Keytruda (Pembrolizumab, Pembrolizumab)

Original research company: Merck

Original research company:

Mechanism of action : PD-1 blocker

Mechanism

Global Approved Indications: Colorectal Cancer; Triple Negative Breast Tumors; Squamous Cell Carcinoma; Renal Cell Carcinoma; Endometrial Cancer; Esophageal Cancer; Small Cell Lung Cancer; Non-small Cell Lung Cancer; Merkel Cell Carcinoma; Hepatocellular Carcinoma; Head and Neck Partial squamous cell carcinoma; melanoma; primary mediastinal B-cell lymphoma; cervical cancer; transitional cell carcinoma; Hodgkin's disease; urinary system tumors; gastric cancer; high microsatellite instability cancer; head and neck cancer
.

Global approved indications:

Approved indications in China: non-small cell lung cancer; melanoma
.

Approved indications in China:

2020 sales: USD 14.
38 billion

2020 sales:

Key patent expiration time: 2028

Key patent expiry time:

The sales of K medicine in 2020 only rank behind Xiu Mei Le, and it is a strong rival to compete with Xiu Mei Le
.

When immunotherapy becomes a direction for the treatment of cancer, the indications and R&D directions of K drugs have become more abundant.

While the sales of drug O, which is also a PD-1 inhibitor, have been declining, drug K has obtained 7 FDA approvals in the past 10 months, and is expected to increase further in the future
.

A research team believes that if medicine K continues to develop in the current situation, it is expected to reach 24.

Regarding the patent expiration in 2028, Merck is also making relevant preparations to make up for the income shortfall after the expiration.
For example, a Canadian company called PlantForm Corporation recently announced its cooperation with Bio-Manguinhos/Fiocruz of the Brazilian Ministry of Health.
The Brazilian market developed Keytruda's generic drugs
.

3.
Revlimid (Lenalidomide)

3.
Revlimid (Lenalidomide)

Original research company: Celgene Corp (acquired by BMS in 2019)

Original research company:

Mechanism of action: IL6 inhibitor; CRBN inhibitor; COX-2 inhibitor; TNFα inhibitor

Mechanism:

Worldwide approved indications: marginal zone B-cell lymphoma; follicular center lymphoma; peripheral T-cell lymphoma; mantle cell lymphoma; multiple myeloma; myelodysplastic syndrome

Global approved indications:

China Approved Indication: Multiple Myeloma

Approved indications in China:

2020 sales:  $12.
1 billion

2020 sales:

Key patent expiration:  2025 to 2026

Key patents expire:

BMS acquired Celgene for 74 billion yuan in 2019.
Due to the acquisition, Revlimid's sales in the same year fell to the lowest level.
However, in 2020, it has rejuvenated and became the third runner-up in sales in 2020, reaching 121 With sales of 100 million U.
S.
dollars, this achievement is inseparable from Revlimid’s multiple price increases.
Celgene was initially sold for 215 U.
S.
dollars, but after 20 price increases, the current price has exceeded 750 U.
S.
dollars
.

Both Celgene before and now BMS are trying their best to ensure that Revlimid is protected from generic competition.
Soon after the acquisition was completed, the US Patent and Trademark Office rejected Revlimid's three patent invalidation applications
.

However, as the patent period approaches, competitors of generic drugs will gradually join the competitive market.

4.
Eliquis (Apixaban, Apixaban)

4.
Eliquis (Apixaban, Apixaban)

Original research company: Bristol-Myers Squibb

Original research company:

Mechanism of action: factor Xa inhibitor

Mechanism:

Global Approved Indications: Venous Thromboembolism; Thrombosis; Embolism; Stroke

Global approved indications:

Approved indications in China: venous thromboembolism; thrombosis

Approved indications in China:

2020 sales: US$9.
2 billion

2020 sales:

Key patent expiry time: 2027 to 2029

Key patent expiry time:

Eliquis was approved by the EMA in 2011 and the FDA in 2012.
In the past ten years, Eliquis has been a star product, and Pfizer and BMS have evenly distributed profits and losses
.

In order to protect its patents, Pfizer and BMS have been cracking down on generic drug rivals for many years.
In 2017 alone, they jointly filed patent infringement lawsuits against 25 companies that have applied to the FDA for approval of their generic drugs
.

In the coming decade, BMS will face the patent cliffs of three blockbuster drugs, namely Eliquis and Revlimid and Opdivo.

In the United States, the first generic drug of Apixaban was approved in December 2019
.

However, the U.

5.
Eylea (Aflibercept Aflibercept)

5.
Eylea (Aflibercept Aflibercept)

Original research company: Regeneron Pharmaceuticals Inc, Bayer

Original research company:

Mechanism of action: PGF inhibitor; VEGFA inhibitor

Mechanism:

Global approved indications: macular edema; age-related macular degeneration; diabetic complications; wet macular degeneration

Global approved indications:

Approved indications in China: macular edema; age-related macular degeneration

Approved indications in China:

2020 sales: USD 8.
36 billion

2020 sales:

Key patent expiration time: 2025 to 2026

Key patent expiry time:

Eylea is facing fierce market competition, especially Novartis’ Beovu.
With the expiration of the patent, Regeneron and Bayer will face the greatest threat from VEGFA inhibitors
.

In the 2020 annual filing to the US Securities and Exchange Commission, Regeneron listed the range of expiry dates, which are divided into several categories, extending from 2023 to 2032
.

Eylea has three formulation patents in the United States.

Amgen expects to complete Eylea's third phase biosimulation test in April 2022.
In November last year, the FDA stated that it would review Samsung Bioepis and Biogen's Lucentis analogue SB11.
The standard review period is 12 months
.

If the review is passed in the second half of this year, Eylea's market will be further eroded

Reference source:

Yaodu Database

Yaodu Database

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