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

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

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

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

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

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

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

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

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

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

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:-

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.