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:-

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

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:-

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

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

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:-

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

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):-

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

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

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

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

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

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

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

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

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

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

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