Defined generic drugs

The authorisation of generic medicinal products is covered by Article 10 of the Human Medicines Directive 2001/83/EC and Article 13 of the Veterinary Medicines Directive 2001/82/EC. A generic drug is defined as a medicinal product that has ... 

A generic drug is defined as a drug that is equivalent to a prescription drug approved by the FDA, but for which the patent validity has expired. An ANDA approval is required (Fig. 8.6). 

Furthermore, it is important to note that these rules are usually derived in relation to a specific project objective, often oral absorption, and are not intended to define generic rules for a drug-like molecule. The most appropriate properties for a compound will depend on many fiictots including the therapeutic area, class of target, and intended route of administration [26]. Despite this, there is a commonly held misconception that rules, such as the RoF, can be used to select drug-like compounds without reference to the intended application, which could be actively misleading [27]. 

Drug ID (cardiovascular Code/generic name Cardiovascular Sponsor-defined clinical Other information... 

It is the Paragraph IV certification that is the most problematic. The generics company may certify that there is a patent but that either the proposed drug will not infringe the patent or that the patent is invalid. This certification is defined as an act of... 

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