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

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

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

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

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

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

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

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

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

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