Authorized Generics: Effect on Pharmaceutical Market

Abstract

The study addresses the effect of authorized generics practice in pharmaceutical market. The practice of marketing an “authorized generic” has been growing in the pharmaceutical industry. An “authorized generic”–sometimes termed a “branded,” or “pseudo” generic–is a pharmaceutical that is marketed by or on behalf of a brand name drug company, but is sold under a generic name. The brand drug companies employ a generic company or its own generic subsidiary to market their drug product; under their own new drug application (NDA). Authorized Generics compete on price, quality and availability basis with generic products approved by the FDA as substitutable for specific brand products. Over the past couple of years, innovator drug companies have been launching authorized generics simultaneously with the first Abbreviated New Drug Applications (ANDA) filer’s launch of its generic drug product. The study analyzed the current prospects of authorized generics practice, examines the effect of authorized generics practice on consumers affordability to medicines, effects on the generic companies to file paragraph IV certifications to challenge patented drugs, study also observed the effect of authorized generics practice on Indian pharma companies. The questionnaire were prepared relevant to study and distributed to the Indian pharma regulatory personnel, and their responses were analyzed