Abstract
Through the 1984 Drug Price Competition and Patent Term Restoration Act, the Indian Pharmaceutical Industry has thrived in the US market by selling generic products at competitive rates. However, the traditional and conservative model is no longer sustainable as we head past the “patent cliff”. An innovative business model characterized by the development of “super-generics”, an improved version of an original drug product which has lost patent protection, is the next logical step as it is relatively less time consuming and less expensive compared to the development of a new chemical entity, while affording higher profit margins and potentially, better patient outcomes compared to generics. This presentation will highlight the current space occupied by these super-generics, why the traditional Indian Pharmaceutical Industry should transition to become more innovative as well as the regulatory, infrastructure and personnel requirements that such a transition would entail.
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