PIV Product Launch Strategies

Our experts are industry leaders with experience in Life Cycle Management and Loss of Exclusivity strategies of innovator (branded) pharmaceutical products, as well as launching PIV and 505B-2 products.

Analysis of Patent Infringement

Pharmaceutical formulations and manufacturing processes are evolving rapidly. New materials and processing methods, innovative testing technologies, and changing regulatory expectations combine to create a dynamic intellectual property landscape.

Are you infringing on someone’s patent? Or is someone infringing yours?

Determination of Product Structure

Brand and generic versions of medicine often contain similar ingredients and are supposed to perform in the same manner.

Are the products the same . . . or are they different?

It often boils down to particles, and how they are assembled to form the product.

Abuse Deterrent Formulations and Technologies

Acumen Biopharma has been involved in opioid IP litigations since 2012, working with 7 clients in 9 different cases, both in the US and in Canada.

To date, Acumen scientists have participated in litigations involving approximately 30 different patents.

Ingredients and Finished Product Testing for Quality Assurance and Regulatory Compliance

Materials and products are tested during process development, commercial manufacturing, and litigation.