Power Alley: Merck Files Patent Infringement Suit Against Xiromed (A Spanish Generics/Pharma Co.), Related To Organon's Legacy Nexplanon® Patents.

It has been a minute since we last dipped into Rahway's ongoing portfolio of patent litigation filings, to preserve the exclusivity it spent billions securing, globally -- for various of its drugs and biologics. Merck got Nexplanon via the Organon transactions over 15 years ago -- but now Organon trades under its own name once again, as a women's health portfolio company.

I think Merck still retains a significant amount of equity in the "new" Organon. So there you have it. In any event, here's the complant at law, in federal court in New Jersey, and a bit:

. . .On information and belief, Defendant Xiromed España is a limited liability company organized and existing under the laws of Spain, with a place of business at Calle de Manuel Pombo Angulo, 28, 3rd floor, Hortaleza, 28050, Madrid, Spain. . . .

On information and belief, Insud is the ultimate parent of both Xiromed España and Xiromed, LLC. On information and belief, Xiromed España and Xiromed, LLC are the business entities through which Insud markets and sells generic drug products in the U.S. market. . . .

By a letter dated February 20, 2025 (“Xiromed Notice Letter”), Xiromed notified Plaintiffs that Xiromed had submitted to the FDA Xiromed’s ANDA for approval to market and sell in the United States a purported generic version of NEXPLANON® (etonogestrel implant, 68 mg/implant) (referred to herein as the “Xiromed ANDA Product”), prior to the expiration of the patents-in-suit. . . .

Insud, in concert with Xiromed España and Xiromed, LLC, has committed an act of infringement in this judicial district by filing Xiromed’s ANDA with the intent to make, use, sell, offer for sale, and/or import the Xiromed ANDA Product in or into this judicial district, prior to the expiration of the patents-in-suit. . . .

NEXPLANON® has two primary components: (1) a matchstick-sized, radiopaque implant containing etonogestrel, a synthetic hormone that prevents pregnancy by inhibiting ovulation, and (2) a novel applicator device used to insert the implant subcutaneously at the proper location in the upper arm. Once inserted, a single NEXPLANON® implant systemically delivers an ongoing low dose of etonogestrel into the bloodstream for up to three (3) years, which then prevents ovulation in the ovaries. When used correctly, NEXPLANON® is over ninety-nine (99) percent effective at preventing pregnancy. . . .

NEXPLANON®, as well as methods of using NEXPLANON®, are covered by one or more claims of the patents-in-suit. The ’037 and ’552 patents are listed with NDA No. 021529 in the FDA’s Orange Book. . . .

Do stay tuned. This one could rumble on for a few years, if not settled. Onward. Here's a 2021 settled-version of the same thing, same patents -- against another generic, as we covered it -- back then. Grin.

नमस्ते