If there are patent restrictions, will generic drugs be approved?

Generic drugs refer to drugs with similar chemical composition and efficacy produced and sold by other companies according to the prescription information and published clinical trial data of the original drug (innovative drug) after the patent period expires. The production process of generic drugs is similar to that of the original drug, but the price is usually much lower than that of the original drug.

In some countries, generic drugs may need to meet certain regulations and conditions before they can be approved. Generally speaking, the approval requirements for generic drugs are: First, the patent period of the original drug has passed; Secondly, generic drugs must have similar efficacy and safety to the original drug, which requires a series of non-clinical and clinical studies to prove that the quality, efficacy and safety of generic drugs are equivalent to the original drug; Finally, the production of generic drugs should meet the standardized drug production standards.

It should be noted that different countries may have different laws and policies and different specific requirements. Therefore, whether generic drugs can be approved, it is best to refer to the laws and regulations of relevant countries or regions. It is best to consult local professional organizations or drug regulatory authorities to obtain accurate and detailed information.