Prescription and over-the-counter (OTC) drug product submissions, patents, and exclusivity are important aspects of the pharmaceutical industry and regulatory process.
Patents are important in the pharmaceutical industry because they provide the owner with exclusive rights to manufacture and sell the drug product for a certain period of time. This exclusivity helps the owner to recoup the cost of research and development and make a profit.
Exclusivity, on the other hand, is a period of time during which the FDA cannot approve a competing drug product. Exclusivity is granted to a drug product under certain circumstances, such as for new chemical entities or for certain pediatric uses. This period of exclusivity allows the drug product owner to have a monopoly on the market for a certain period of time.
In summary, prescription and OTC drug product submissions, patents, and exclusivity work together to ensure that safe and effective drugs are available to patients while also protecting the intellectual property rights of the manufacturers.
This course is designed to provide a high-level overview of the differences between prescription and non-prescription drugs as well as the submission and review processes. In addition, the course highlights the various patent and exclusivity privileges for generic and brand-name drug sponsors and how generic drug approvals are being affected by these types of patents and exclusivity.
Different New Drug Application (NDA) types and submission process for Prescription Drugs
Review and Final Decision Process for Prescription Drugs
Regulatory Submission Process for OTC Drugs
User Fees for Prescription and OTC Drugs
Patents and Exclusivity Provisions
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