by inpharmedia | Dec 19, 2021 | Blog, Regulatory
The Hatch-Waxman Act provides certain market exclusivities for new drug applicants based on two factors: Patent Non-patent The patent related exclusivities are part of the discussion and we will learn further in this article. PATENT EXCLUSIVITY & the ORANGE BOOK:... by inpharmedia | Aug 15, 2021 | Blog, Regulatory
Exclusivity: Exclusivity is exclusive marketing rights granted by the Health Authority upon approval of a novel drug molecules and can run concurrently with a patent or not. It prevents the submission or effective approval of generic applications and was designed to...
by inpharmedia | Apr 27, 2021 | Blog, Regulatory
Every new drug must prove to be safe and effective to be approved by any health authorities. The new drug/therapeutic moieties invented are protected by a specific patent that allows the innovator firm or patent holder to enjoy the exclusivity to market the product...
by inpharmedia | Jan 9, 2021 | Blog, Regulatory
The Refuse to Receive (RTR) standards play a critical role in the ANDA (Abbreviated New Drug Application) submission process, acting as the initial gatekeepers for regulatory approval. These standards are designed to ensure that submitted applications meet the...
