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

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

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

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

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

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

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

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

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

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:-

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.

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

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

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

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

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

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:-

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.

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

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

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

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

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

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

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

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