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

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

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

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

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:-

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

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

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

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

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

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

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:-