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

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

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

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

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

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

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

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

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

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

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

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

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

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

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'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:-