FTO Generic, check both Orange Book and FDA information at once

 

 What is the exact meaning of 'generic medicine', which was previously referred to as 'copy drugs'?

It refers to a medicine that is made using the disclosed technology of an original medicine whose patent has expired, and has the same main ingredient, content, formulation, efficacy, and dosage as the original medicine. It is a product that has been recognized by the pharmaceutical management agency of each country, such as the Ministry of Food and Drug Safety, as a product equivalent to the original medicine through a pharmaceutical equivalence test.

 A new medicine that a pharmaceutical company first makes is called an original. This medicine is protected by a patent. Generally, a patent is protected for 20 years from the date of application, but considering the period of product development, the actual effective patent period is about 15-18 years. Unlike other products whose sales volume drops sharply as the patent expiration date approaches, pharmaceutical sales tend to increase rapidly, so the patent protection period is often extended for several years. For this reason, the United States has been implementing the Patent Term Extension (PTE) system since 1984.

 Patent term extension is a system that extends the term of a patent for a certain period of time in cases where the patent cannot be actually enforced due to a long period of time required to obtain regulatory approval (Regulatory Review Period; RRP) during the patent term. After this system was introduced in the United States, other countries have introduced similar systems one after another. Korea also introduced the substance patent system in 1987, and the patent term extension system has been implemented since 1999. Multinational pharmaceutical companies devise protection strategies to effectively utilize the patent term extension system, and generic pharmaceutical companies devise various methods to avoid their patent extension strategies.

 With blockbuster diabetes treatment drugs set to expire one after another in the next three years, generic pharmaceutical companies are seeking various patent strategies to quickly enter the market and take the lead.

 The FDA is publishing the Orange Book to provide information on the evaluation of therapeutic equivalence of various prescription drugs to pharmacists in the United States. The Orange Book contains patent information on approved new drugs, and is used as important data for resolving pharmaceutical patent disputes. WIPS Global provides an FTO Generic search service by implementing a convergence service that links the Orange Book and US patents. Let’s take a look.

wipsglobal.com> FTO Generic

This is the Orange Book search field. You can search from three perspectives: product information, exclusive information, and related patent information (US registered patents).

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 This is the search results screen. Based on the FDA application unit field, the corresponding product field is grouped (product number, type, pharmaceutical product name, patent number, dosage form; administration route, content, therapeutic equivalence code, reference drug) and displayed as a list.

wipsglobal.com> FTO Generic

 Click on the FDA application number to check the detailed information of the corresponding application information. This is a page that provides all the information held by the Orange Book. You can see product information, exclusive information, and related patent information (US registered patents) of the FDA application.

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 Click on the patent number of the related patent (US registered patents) to go to the View Details and check detailed information such as bibliography, claims, description, trial/litigation, and chemical compounds.

wipsglobal.com> FTO Generic

 The related patent list is connected to ‘My Folder’ and ‘Easy Viewer’, so you can save it in My Folder or quickly review multiple patents.

wipsglobal.com> FTO Generic

 We provide a list of pharmaceutical patents that can be freely implemented. You can review the list of expired pharmaceuticals by selecting the year of expiration and the year of upcoming expiration.

 So far, we have looked at the FTO Generic search features provided by WIPS Global. 

Please make use of FTO Generic to view detailed information on new drugs and related patents from the Orange Book.