Generic pharmaceutical products are the pharmaceutical and therapeutic equivalents of the brand product. Accordingly, generic products provide a safe, effective and cost-efficient alternative to users of these reference brand.
Generic product development is generally less time-consuming and complex than the new chemical entity development process. It usually does not require new preclinical and clinical studies, because it relies on the studies establishing safety and efficacy conducted for the referenced innovator product, often called the Reference Listed Drug or RLD. It may require one or more bioequivalence studies to show that the generic drug is bioequivalent to the previously approved reference listed brand drug (RLD). On occasions a bioequivalence study waiver (“biowaiver”) may be granted. The RLD is a product that has been previously approved through the respective regulatory agency such as the Food and Drug Administration (FDA) in the Unites States, the Therapeutic Goods Administration (TGA) in Australia or the European Medicines Agency (EMA). Acrux’s major focus will be FDA approval of its generic product. The FDA application to market a generic drug is called an Abbreviated New Drug Application (ANDA) and once approved, the product is listed in the FDA’s publication popularly known as the Orange Book.
Generic products are generally introduced to the marketplace at the expiration of patent protection for the brand product, or at the end of a period of non-patent market exclusivity. However, in In the United States, if an ANDA applicant files an ANDA containing a certification of invalidity, non-infringement or unenforceability related to a patent listed in the Orange Book with respect to a reference drug product, the applicant may be able to market the generic equivalent prior to the expiration of patent protection for the brand product. Such patent certification is commonly referred to as a Paragraph IV certification. If the holder of the RLD sues, claiming infringement or invalidation, within 45 days of notification by the applicant, the FDA may not approve the ANDA application until the earlier of the rendering of a court decision favourable to the ANDA applicant or the expiration of 30 months. An ANDA applicant that is first to file a Paragraph IV certification is eligible for a period of generic marketing exclusivity. This exclusivity, which under certain circumstances may be required to be shared with other ANDA sponsors that have made Paragraph IV certifications, lasts for 180 days, during which the FDA cannot grant final approval to other ANDA applications for a generic equivalent to the same reference drug.