Merck's Bridion® Generated ~$1.84 Billion In Sales In 2023 -- Now Hikma And Five Others Seek Early Generic Copy Authority Under Hatch-Waxman...

We have followed the chemical known generically as sugammadex, since about 2008, when it was a nascent Schering-Plough candidate, then one of Fred Hassan's "five stars". It is sold in the OR to help awaken patients, post surgery. [Except that it was seven years late in arriving, it is/was a success.] Indeed, it has slowly grown over the years -- to be a nice blockbuster for Rahway.

The molecule is fairly easy to synthesize. . . and thus makes a rather promising "at risk" launch project, under Hatch-Waxman (even prior to 2026, in the US). And so it is not surprising that it has attracted the attention of at least five US generic manufacturers, since 2023 -- seeking to compete with it. It went off patent in the EU as of 2023, and will soon be so, in Japan here early in 2024.

Apparently, last week a sixth generic entrant emerged -- Hikma Pharmaceuticals' generics arm. Merck's Form 10-K discloses it is still deciding whether it might allow one or more versions of an "authorized" generic, to blunt Hikma and the others -- possibly with some other purveyor. Here is that bit -- but overall, this is not likely to be material, since Bridion is only about Merck's sixth largest franchise (see page 106):

. . .As previously disclosed, in June 2023, the U.S. District Court for the District of New Jersey ruled in Merck’s favor. The court held that Merck’s calculation of PTE for the sugammadex patent covering the compound is not invalid and that the U.S. Patent & Trademark Office correctly granted a full five-year extension. This ruling affirms and validates Merck’s U.S. patent protection for Bridion through at least January 2026. On June 29, 2023, the U.S. District Court for the District of New Jersey issued a final judgment prohibiting the FDA from approving any of the pending or tentatively approved generic applications until January 27, 2026, except for any subsequent agreements between defendants and Merck or further order by the court.

In July 2023, defendants filed a notice of appeal with the United States Court of Appeals for the Federal Circuit. The appeal is currently pending.

On February 5, 2024, the Company received another Paragraph IV Certification Letter under the Hatch-Waxman Act notifying the Company that Hikma Pharmaceuticals USA Inc. has filed an application to the FDA seeking pre-patent expiry approval to sell a generic version of Bridion Injection. The Company is currently considering its options. . . .

Now you know -- with just one of my older backgrounders, here. Search "sugammadex" in the box at upper left -- for over 45 other entries.

Be excellent ot one another. Smile. . . .

नमस्ते