Regulatory Services for Generics

Generic and Innovator drugs bear many similarities, except the pricing. A Generic drug has the same dosage, safety, effectiveness, strength, stability, quality, and performance characteristics as an innovator drug. It is also consumed in a manner similar to an Innovator drug. However, it is far more economical when compared to an Innovator drug. With an objective to produce high quality pharmaceutical formulations, Generic drug manufacturers strive to identify the most critical needs of patients across the globe and devote their resources to meet them by developing safe, effective, and affordable healthcare solutions as an option to Innovator drugs.

Innovators are protected by patents and exclusivities that influence how and when a generic drug can be approved and marketed. These patents, usually issued by the US Patent and Trademark Office, protect the Innovator drug manufacturers by prohibiting others from selling generic versions of the same drug. Periods of marketing exclusivity for Innovator drugs can also impact the approval of generic drugs. Once these patents and marketing exclusivities expire (or if the patents are successfully challenged by the generic drug company), the Generic drug can receive full approval and can be distributed and made available to the public.

Generic drugs are more cost-effective when compared to Innovator counterparts because they do not have to repeat animal and clinical (human) studies that were required by the Innovator. In addition, multiple applications for Generic drugs for the same formula are often approved which creates competition in the marketplace that typically results in lower prices.