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

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

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

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

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

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

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

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

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

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

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.