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

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

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

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

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

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

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

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

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

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

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

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:-

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

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

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

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

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

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:-