A supplementary protection certificate (SPC) is a type of intellectual property right granted in the European Union. It provides an extension of the term of protection for a medicinal product that has been authorized for sale in the EU, beyond the 20-year term provided by the basic patent.

The aim of SPCs is to compensate for the time taken to get regulatory approval for a new drug, and to provide an incentive for companies to invest in research and development in the field of medicinal products.

You can seek FDA approval to launch a generic drug before the expiration of ACULAR LS's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the ACULAR LS's sponsor is invalid, unenforceable, or will not be infringed by your generic product.

Here are the details of the already filed Para IV certificates on ACULAR LS:-

You can seek FDA approval to launch a generic drug before the expiration of ACUVAIL's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the ACUVAIL's sponsor is invalid, unenforceable, or will not be infringed by your generic product.

Here are the details of the already filed Para IV certificates on ACUVAIL:-

You can seek FDA approval to launch a generic drug before the expiration of SPRIX's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the SPRIX's sponsor is invalid, unenforceable, or will not be infringed by your generic product.

Here are the details of the already filed Para IV certificates on SPRIX:-