About Botanical Drugs

A botanical drug is a plant-derived medicinal product that is intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in humans. Often based on a complex botanical compound, botanical drugs can offer a multiple agent solution, selectively and differentially affecting various target tissues. These characteristics position botanical drugs as safe and effective therapeutic solutions.
Pioneering the field, in 2006 the USFDA has published the Botanical Drug Products Guideline, which provides guidance for clearance of plant based medications. Under the botanical drug guideline, botanical drugs are cleared for specific indications just like a regular drug, thereby coded and accessible for medication reimbursement plans. In the European Union and other countries, plant-based medications are classified as Herbal Medicinal Products either under national country by country guidance or through the European Medicines Agency, the EMEA.
Drugs cleared within the USFDA Botanical Drugs Category bear the rights and obligations as any other drug. Being from Botanical Origin, however, it has the benefit of being able to gather both efficacy and safety data by marketing the product as a dietary supplement. This market history may facilitate the clearance procedure within the USFDA, based on the significant safety and efficacy data gathered, while being marketed over the counter to consumers and health care professionals in different countries.
Designing and implementing effective and efficient standardization controls on the botanical complex is a key element in the process of developing a novel botanical drug. Manufacturing sites of botanical drugs are required to uphold full pharmaceutical cGMP starting with the production of the API (active pharmaceutical ingredient) and until a finished and packed product is cleared for release. As part of the novel drug candidate’s CMC (Chemistry, Manufacturing and Control) manufacturers are also required to demonstrate ability to identify and quantify the API, as a mean to ensure therapeutic consistency of the drug.
Effective IP strategy concerning botanical drugs, aims to integrate and tie patents covering different aspects of the new drug with aspects disclosed in the CMC submitted to the FDA. In addition to patent-derived exclusivity, once a botanical drug is cleared by the FDA, it enjoys a five-year market exclusivity from the FDA, with respect to the indication it was cleared for and the intellectual properties disclosed in the CMC.  
A botanical drug, as any other new drug, must be scientifically substantiated, manufactured under rigorous pharmacological standards and should have a solid intellectual property base to support commercialization. At the same time, under the FDA’s guidelines developers of botanical drugs are offered a unique track, encouraging them to substantiate new drug candidates by gaining significant market experience, which ultimately, improves the probability of meeting Phase III studies endpoints, towards new drug approval.

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