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:-

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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