Types of Market Exclusivities and Implications on Forfeiture
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: The innovator typically obtains patent protection for their approved drugs and have a period of exclusivity that prevents unlicensed third parties from making, using, offering for sale, selling or importing the patented invention....
Types of Exclusivities and Incentive Periods by Global Health Authorities
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 promote a balance between new drug innovation and generic drug competition. TYPES OF EXCLUSIVITIES: Every region has two different types of exclusivities. Data Exclusivity Market Exclusivity Data exclusivity is the exclusive rights...
The Hatch-Waxman Act : Balancing Drug Patents and Generic Entry
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 and doesn’t allow other players to enter the markets. Typically, when any innovator discovers a potentially significant moiety, the innovation will be immediately protected by securing the patent rights in relevant regions....
Navigating Refuse to Receive (RTR) Standards: Key Insights for Successful ANDA Submissions
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 necessary criteria for review by the FDA. A failed RTR decision can lead to delays, additional costs, and even the rejection of a submission. Understanding the key considerations surrounding RTR standards is essential for pharmaceutical...
Unlock Product Development with the Inactive Ingredient Database (IIG)
What is Inactive Ingredient Database? Inactive Ingredient Database (IIG) Database is a collection and aligned set of inactive ingredients, that are to be present or appeared in FDA approved drug products, allowing industry to access for development of new products. The first version of database made available in 1987 as hardcopy and an online database came to limelight in 2003. Inactive Ingredient An inactive ingredient is a component of a dosage form, other than the active ingredient, which...