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2018;20 Suppl 1:5-21

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According to WHO, tobacco kills up to half of its users who dont quit, totalling more than 7 million people annually, including an estimated 1.6 million non-smokers who are exposed to second-hand smoke

The FDAs Orange Book formally titled Approved Drug Products with Therapeutic Equivalence Evaluations sits at the center of pharmaceutical IP strategy because it determines which patents can trigger the Hatch-Waxman automatic 30-month stay of generic approval