US FDA Guidances Published in March 2022
US FDA has issued a series of guidance’s to assists the sponsor and applicant in the generic drug development. The March month has around 02 new/revised guidance under GDUFA and ICH provisions. The links of the guidance’s are provided below for quick review and reference. 1. Pre-Launch Activities Importation Requests (PLAIR) https://www.fda.gov/media/86243/download 2. ICH Q14: Analytical Procedure Development...
US FDA Guidances Published in January 2022
US FDA has issued a series of guidance’s to assists the sponsor and applicant in the generic drug development. The January month has around 04 new/revised guidance under GDUFA and ICH provisions. The links of the guidance's are provided below for quick review and reference. 1. Technical Specifications for Submitting clinical trial data sets for treatment of Noncirrhotic Non-alcoholic Steatohepatitis (NASH) https://www.fda.gov/media/151870/download 2. Revising ANDA Labeling following revision...
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 – Overview and Impact on Generic Drug Approvals
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....