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 AFINITOR's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the AFINITOR'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 AFINITOR:-

You can seek FDA approval to launch a generic drug before the expiration of APTIOM's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the APTIOM'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 APTIOM:-

You can seek FDA approval to launch a generic drug before the expiration of AURYXIA's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the AURYXIA'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 AURYXIA:-

You can seek FDA approval to launch a generic drug before the expiration of CRESEMBA's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the CRESEMBA'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 CRESEMBA:-

You can seek FDA approval to launch a generic drug before the expiration of GATTEX KIT's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the GATTEX KIT'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 GATTEX KIT:-

You can seek FDA approval to launch a generic drug before the expiration of KUVAN's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the KUVAN'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 KUVAN:-

You can seek FDA approval to launch a generic drug before the expiration of LENVIMA's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the LENVIMA'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 LENVIMA:-

You can seek FDA approval to launch a generic drug before the expiration of MYDAYIS's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the MYDAYIS'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 MYDAYIS:-

You can seek FDA approval to launch a generic drug before the expiration of NATAZIA's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the NATAZIA'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 NATAZIA:-

You can seek FDA approval to launch a generic drug before the expiration of ORENITRAM's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the ORENITRAM'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 ORENITRAM:-

You can seek FDA approval to launch a generic drug before the expiration of SAXENDA's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the SAXENDA'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 SAXENDA:-

You can seek FDA approval to launch a generic drug before the expiration of TRACLEER's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the TRACLEER'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 TRACLEER:-

You can seek FDA approval to launch a generic drug before the expiration of XIIDRA's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the XIIDRA'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 XIIDRA:-

You can seek FDA approval to launch a generic drug before the expiration of XTANDI's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the XTANDI'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 XTANDI:-

You can seek FDA approval to launch a generic drug before the expiration of ZETIA's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the ZETIA'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 ZETIA:-