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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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