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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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