Extend Market Exclusivity

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Extend Market Exclusivity

Generally, in order to protect branded drugs from low-cost generics, the market for exclusive use of innovative drugs granted by the FDA is 12 to 16 years. Although the market exclusivity can significantly promote the financial benefits for pharmaceutical manufactures, the quick development of generics is undoubtedly runs counter to the revenue from branded drugs. Given that generics are always marketed for 80% or more off of the cost of the branded product, implementing another period of market exclusivity is therefore of great importance to those manufacturers of branded drug.

Below is a list of our services for your development protocol (include but not limited to the following):

Create product differentiation/Enhance product performance

Create product differentiation or enhance product performance has been recommended as an efficient strategy for market exclusivity extending of the branded product. Not only because of business issues, including intellectual property, lifecycle management, cost and market differentiation, innovative formulations offer more advantages, such as improved efficacy and duration of drug activity, improved patient compliance and reduced unnecessary side effects.

  • Modified release formulation
  • Sustained release or delayed release formulation
  • Microsphere preparation technology
  • Microcapsule preparation technology
  • Liposomes preparation technology

Candidate drug compounds of different solid forms have significant differences in physicochemical properties, including particle size distribution, solubility, crystal form, and other characteristics. Therefore, screening and selection of the ideal API solid forms is critical to obtain the highest standard quality, performance and good manufacture reproducibility. Since drug substances can be exhibited as various forms such as polymorphs, hydrates, solvates, cocrystals, salts, and the amorphous forms, thus the primary goal of solid-form screening and selection is to achieve the optimal solid forms through identification as many forms as possible. In addition to the traditional solvent- and nonsolvent-based methods, BOC Sciences can employ a variety of latest and specialized screening approaches to meet your requirements for polymorph, salt, cocrystal, amorphous, and amorphous dispersion screens.

  • Salt Screening
  • So-crystal Screening
  • Amorphous Solid Dispersions Screening

Why Choose BOC Science?

BOC Sciences has a team of highly experienced experts who are professional in development of various pharmaceutical products and re-formulation of the approved drugs. We can provide you with a wide range of market-specific extension strategies, such as enhance product performance and potential market protection, through our adequate resources of competent personnel and state-of-the-art techniques. Our experts will provide a detailed development protocol and communicate with you for optimizing very specific of the project.

References

  • Yin, N. (2012). Pharmaceuticals, incremental innovation and market exclusivity. Toulouse School.
  • Kesselheim, A. S., Sinha, M. S., & Avorn, J. (2017). Determinants of market exclusivity for prescription drugs in the United States. JAMA internal medicine177(11), 1658-1664.
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