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

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

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

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

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:-

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

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 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:-

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

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

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

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

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

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

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