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A patent confers an explicit legal right on the inventor or the patent holder and may include entities such as a brand, a trademark, and the dosage form of a product, also the formulation of ingredients or the manufacturing process. A patent generally expires 20 years from the filing date, and more so but may vary depending on many factors,AND MORE SO
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Exclusivity is the only marketing right that the FDA grants to a manufacturer after approval of a drug and can be initiated at the same time as a patent. Exclusivity periods can last from 180 days to seven years, depending on the circumstances of granting exclusivity.
A reference drug (RLD) is an approved drug that compares new generic versions that show that they are bioequivalent. A pharmaceutical company requesting a marketing authorization for a generic equivalent (ANDA).
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