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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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:-

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

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

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:-

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

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

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

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

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:-

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

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

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:-