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

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

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

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

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

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

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

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

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

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

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

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

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

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:-