Grünenthal partners with a wide range of companies to protect an even wider range of products. What can we do for yours?

Grünenthal is a proven leader in ADF technology. If you are looking for ADF protection for your product, including IR opioids or prescription stimulants, we will work with you to find the best solution.

 

Partnering Model

Grünenthal seeks further licensing partners for its extended and immediate-release INTAC® technology. We are also investing in the development of selected opportunities in the IR opioid and prescription stimulant space and are entertaining discussions with prospective partners in order to start additional collaborations.

The typical collaboration model would be a joint, US-centered development of a product-technology combination up to approval.

Development timelines for a product with Grünenthal's INTAC® technology up to regulatory submission will depend on the targeted product profile (TPP) of the product to be developed and the respective clinical and regulatory development strategy.

In general, the development starts with a definition and mutual agreement of the target product profile and drafting of the development plan until submission. Typically, a feasibility study (high/low dose strengths; initial/supportive stability) is performed by Grünenthal as the first phase of the development. Depending on the outcome of this prototype phase, decision for further development is made by the partner, and a full development plan is defined and carried out by both parties. Different collaboration models can be structured between a partner and Grünenthal.

 Depending on circumstances, a bioequivalence approach or a clinical efficacy program can be the foundation for regulatory approval strategy. Under the FDA 505(b)2 statute, an INTAC®-based product may gain an additional exclusivity period of three years independently of patent exclusivity, once the product receives approval by the authority with an abuse-deterrent label or other differentiating product properties.

 

 

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INTAC®