Grünenthal and Apotex Inc. have announced a new licensing agreement granting Apotex exclusive rights in Canada to Nebido (testosterone undecanoate), a long-acting injectable therapy used to treat male hypogonadism, also known as testosterone deficiency.
Under the terms of the agreement, Searchlight Pharma — Apotex’s branded medicines division — will seek regulatory approval for the therapy and, if authorised, handle its marketing and distribution across Canada. Grünenthal will receive an upfront payment along with regulatory milestone payments and a sales-based margin.
The companies said the arrangement builds on their existing collaboration and is intended to expand patient access to treatments addressing unmet medical needs in men’s health.
Jan Adams, Chief Commercial Officer at Grünenthal, said the partnership strengthens the global presence of the Nebido brand while helping patients in Canada gain access to an established therapy. He noted the treatment has a long track record and could benefit many people living with testosterone deficiency, a condition linked to fatigue, reduced muscle mass, mood changes, and other health complications.
For Apotex, the agreement marks entry into a new therapeutic area. Mark Nawacki, President of Searchlight Pharma, said Nebido fills a recognised need in men’s health and represents the company’s first step into testosterone therapy. He added the product will broaden the company’s branded portfolio and expand its specialty-care footprint in the Canadian market.
Nebido is a long-acting injectable formulation designed to maintain stable testosterone levels over extended dosing intervals, potentially reducing the frequency of treatment compared with shorter-acting therapies. The product is already marketed in multiple international markets, though it must still undergo regulatory review in Canada before commercial launch.
Grünenthal acquired global rights to the brand in 2022 as part of a broader growth strategy focused on expanding its pain management and specialty medicine portfolio. Since 2017, the company has invested more than €2 billion in mergers and acquisitions to diversify operations and strengthen profitability. The company said it continues to integrate newly acquired brands across manufacturing, supply chain, logistics and commercial infrastructure.
The agreement reflects ongoing consolidation and partnership activity in specialty pharmaceuticals, as companies seek regional collaborators to accelerate regulatory approvals and distribution while managing development costs.