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

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

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

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

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

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

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

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

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

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

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

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