Vecuronium Bromide

Merck Research Laboratories in South San Francisco, California iStock, hapabapa Despite a patent extension, Merck’s muscle relaxant reversal injection is now facing potential generic competition from Hikma Pharmaceuticals, which is seeking the FDA’s approval for a copycat version. Pictured: Merck research laboratories in California/iStock, hapabapa Merck in an SEC filing disclosed on Monday that Hikma Pharmaceuticals U.S. is seeking the FDA’s approval for its generic version of the muscle relaxant reversal injection Bridion (sugammadex) prior to the drug’s patent expiration. Hikma notified Merck of its intention on Feb. 5, 2024, according to the SEC filing. The British pharma is making its regulatory request under the Hatch-Waxman Act —also known as the Drug Price Competition and Patent Term Restoration Act of 1984—which established the approval pathway for generics. Specifically, Hikma is seeking approval for its Bridion copycat through a Paragraph IV Patent Certification letter, which according to the FDA’s website allows the approval of generics given that the patent for its reference product is “invalid, unenforceable, or will not be infringed by the generic product.” Under the Paragraph IV process, Merck has 45 days from being notified of the patent challenge to infringement suit against Hikma. While the court resolves the complaint, the FDA’s approval for the generic product is generally postponed for 30 months, unless the patent expires or a judge decides against the patent holder before then. Merck is “currently considering its options,” according to its SEC filing. Bridion is a modified gamma cyclodextrin that works by diffusing through the patient’s plasma and capturing the neuromuscular blocking agents rocuronium and vecuronium. The injectable drug first won the FDA’s approval in 2015 for use in adults undergoing surgery. It carries warnings against anaphylaxis and bradycardia, while its most common adverse events include vomiting, pain and nausea. The drug is one of Merck’s top-selling assets—and is still showing signs of growth. In 2023, Bridion brought in a little more than $1.84 billion, an increase from nearly $1.69 billion in revenue in 2022 and $1.53 billion in 2021, according to the SEC filing. In June 2023, the U.S. District Court for the District of New Jersey ruled in favor of Merck , finding that the company had correctly calculated its Patent Term Extension duration for Bridion. The court ruling protects Bridion from generic competition in the U.S. through at least January 2026. Bridion’s protections have already expired in the EU, in Japan and in China. At the time, Merck General Counsel Jennifer Zachary in a statement said that the decision will ultimately allow the company “to continue investing in research and development,” bringing new and innovative treatments to patients with unmet medical needs. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com .

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 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.