Dexcel Pharma Buys Zubsolv Rights in Major US Branded Market Push

PARSIPPANY, NJ – January 07, 2026 – In a significant strategic maneuver, Dexcel Pharma USA announced today it has acquired the U.S. rights to Zubsolv®, a key medication for opioid use disorder, from Swedish pharmaceutical firm Orexo AB. The deal, valued at over $90 million, signals a major push by the company into the competitive U.S. branded drug market and positions it as a new key player in the nation's ongoing battle against the opioid crisis.

The transaction, which closed on December 31, 2025, includes Zubsolv® (buprenorphine and naloxone) sublingual tablets and the entire associated commercial infrastructure. This turnkey acquisition provides Dexcel not just with a product, but with an established sales and marketing platform in a multi-billion dollar therapeutic area.

A Strategic Leap into the Branded Arena

For Dexcel Pharma USA, the American subsidiary of Israel's largest private pharmaceutical company, this acquisition marks a transformative step. The company, which rebranded from Edenbridge Pharmaceuticals in October 2024, has historically operated with a portfolio mixing generics, specialty drugs for rare conditions, and a smaller branded product, Hemady®, for multiple myeloma. The addition of Zubsolv® represents a substantial escalation of its branded ambitions.

"Dexcel Pharma is excited to be adding the Zubsolv® product and related commercial capabilities from Orexo into our expanding US operations," said Doug Boothe, the company's CEO, in a statement. "This product, together with our proven sales & marketing platform, will enable Dexcel Pharma's strategic growth in the U.S."

The move is a calculated entry into a high-stakes market. By acquiring an established product with annual sales of approximately $49 million in the twelve months prior to the agreement, Dexcel circumvents the lengthy and costly process of developing and launching a new branded drug from scratch. The company is leveraging the financial backing of its parent, Dexcel Pharma, which has invested over $500 million in research, development, and capital expenditures in the last decade, to secure a significant foothold in the American pharmaceutical landscape.

The Value of an Established OUD Therapy

Zubsolv® is a critical tool in Medication-Assisted Treatment (MAT) for Opioid Use Disorder (OUD). First approved by the FDA in 2013, the sublingual tablet combines buprenorphine, which mitigates withdrawal symptoms and cravings, with naloxone, which helps deter misuse. While Indivior’s Suboxone® film remains the dominant force in the market, Zubsolv® carved out its niche by addressing patient and physician needs directly.

Clinical data and patient feedback highlight several advantages for Zubsolv®. It boasts higher bioavailability, meaning a lower dose can achieve the same effect as competing buprenorphine/naloxone tablets. This, combined with a faster dissolve time and a more palatable taste, has led to high patient preference, with studies showing over 70% of patients preferring its attributes after trying both Zubsolv® and Suboxone film. Furthermore, Orexo developed a wide range of dosage strengths in response to physician requests for greater dosing flexibility, enhancing its clinical utility.

Dexcel is stepping into a market defined by immense need. The U.S. Opioid Use Disorder market was valued at over $3 billion in 2025 and is projected to surge to more than $9.6 billion by 2034, driven by persistent high rates of opioid addiction and robust government initiatives to expand access to treatment. Dexcel's acquisition places it directly into this dynamic and growing sector, inheriting a product with a proven track record and established patient base.

Shifting Tides in Specialty Pharma M&A

The deal also serves as a case study in the evolving strategies of specialty pharmaceutical companies. For the seller, Orexo AB, the divestment is a strategic pivot. The transaction, with its $91 million upfront payment and potential for nearly $17 million in sales-based earn-outs, allows the Swedish company to eliminate its corporate debt and redirect capital towards its future.

Orexo plans to intensify its focus on its proprietary AmorphOX® drug delivery platform and accelerate high-potential pipeline projects. These include new rescue medications for opioid overdose, such as Izipry™, and treatments for anaphylaxis. This move reflects a broader industry trend where companies monetize mature, stable assets to fund riskier but potentially more lucrative next-generation research and development.

The financial terms underscore the value placed on Zubsolv®'s established revenue stream. Dexcel paid a fixed price of $91 million, plus an additional sum between $3.8 million and $5 million for existing inventory. The contingent earn-out payments are tied directly to Zubsolv®'s net sales performance through 2026 and 2027, creating a shared interest in the product's continued success. This structure allows Orexo to benefit from a smooth transition while Dexcel takes the reins on commercial operations.

Implications for the Fight Against Opioid Addiction

With this acquisition, Dexcel Pharma USA assumes a significant responsibility in the public health landscape. The company has publicly committed to working with partners to "ensure continued access to this important therapy," a crucial pledge given the life-and-death nature of OUD treatment. The stability of the supply chain and affordability of Zubsolv® will be closely watched by healthcare providers, patient advocacy groups, and public health officials.

The company will face a challenging competitive environment. It must contend with the market leader Suboxone®, its generic versions, and newer long-acting injectable treatments like Sublocade, which is gaining market share due to its once-monthly dosing schedule. Dexcel's ability to effectively manage the existing commercial infrastructure and leverage its own marketing expertise will be critical to maintaining and potentially growing Zubsolv®'s position.

As Dexcel integrates Zubsolv® into its expanding U.S. operations, its performance will not only determine the success of its strategic leap into branded pharmaceuticals but will also directly impact the availability of a vital treatment option for thousands of Americans grappling with opioid addiction.