Merck Secures Bridion Patent Protection Through January 2026
15 Jun 2023
Drug ApprovalPatent InfringementPatent Expiration
Pictured: Merck logo on building/iStock, Sundry Photography
Tuesday, the U.S. District Court for the District of New Jersey ruled in favor of Merck, finding that the company has correctly calculated the Patent Term Extension period for its muscle relaxant reversal medicine Bridion (sugammadex).
In the medical and pharmaceutical industry, patents are typically awarded before a drug candidate or investigational device goes through the FDA’s lengthy evaluation process. A Patent Term Extension returns some of this time lost during regulatory review and prolongs the product’s market exclusivity.
Merck’s court victory Tuesday ensures Bridion is protected from generic competition through at least January 2026.
Tuesday’s ruling contributes “to a broader ecosystem that allows us to continue investing in research and development” and bring new and innovative medicines and vaccines to address unmet medical needs and improve patient outcomes, Jennifer Zachary, executive vice president and general counsel at Merck, said in a statement.
Bridion won the FDA’s approval in 2015 to reverse neuromuscular blockade induced by rocuronium and vecuronium in adults undergoing surgery. The injectable drug is a modified gamma cyclodextrin that diffuses through the plasma and captures the blocking agents.
The drug’s label carries precautions for anaphylaxis and bradycardia. Patients given Bridion should also remain on air support until they can breathe properly on their own.
Bridion is one of Merck’s leading assets and is still showing signs of healthy growth. In the first quarter of 2023, Bridion brought in $487 million in total sales, making it Merck’s fifth best-selling drug. This revenue marks a 23% increase from the same time period the year prior. In 2022, Bridion was Merck’s sixth top-seller, making the company nearly $1.7 billion, a 10% increase from its 2021 revenue.
Bridion is the strongest product under Merck's Hospital Acute Care business, outpacing the cytomegalovirus prophylactic Prevymis (letermovir) and the broad-spectrum antibacterial Primaxin (imipenem/cilastatin).
This sales performance, along with the extended patent protection, will help Merck maintain its strong business growth and achieve its revenue target of more than $20 billion in the next decade, the company announced during the J.P. Morgan Healthcare Conference.
Merck’s court victory for Bridion comes just days after Johnson & Johnson settled its own patent issue with Alvotech and Teva, granting the partners a license of entry for their Stelara (ustekinumab) biosimilar no later than February 21, 2025. A few weeks earlier, J&J again settled with Amgen to allow the latter’s biosimilar to enter the U.S. no later than January 1, 2025.
Meanwhile, patent problems are compounding for Moderna and Pfizer, which last week received separate lawsuits regarding the mRNA technology used in their COVID-19 vaccinesCOVID-19 vaccines.
Tristan Manalac is an independent science writer based in metro Manila, Philippines. He can be reached at tristan@tristanmanalac.com or tristan.manalac@biospace.com.
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