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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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