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    affordability as I would want them treated and get our life back. Glad I am not alone and there are good people around. Thank you for your time. The Hatch-Waxman Act of 1984 seeks to preserve incentives for innovators to undertake R D but at the same time offers rewards for generic entry. Nonetheless, as noted by Jeremy Bulow, several features of the Act provide incentives to game the system. 6 The pay-to-delay deals are one such example. Under section IV of the Hatch-Waxman Act, a generic maker can submit an abbreviated new drug application (ANDA) with the Food and Drug Administration (FDA) to launch a generic version of a patented drug when all the relevant patents expire, or to certify that the patents are invalid or are not infringed by the generic product. The manufacturer of the branded drug can sue the generic maker, which automatically delays the ANDA approval for 30 months to permit litigation. If, however, the generic maker wins the litigation, it is granted a six-month market exclusivity period. The litigating parties may reach an agreement in which the branded manufacturer may convince the generic filer to drop the challenge to the patent. In return, it can offer a licensed exclusive six-month entry at a later date, but before the expiration of the registered patent date. This can be achieved by first reaching a non-exclusive licensing agreement with a second ANDA filer, who does not have automatic six-month market exclusivity under the section IV clause, and then offering an exclusivity deal to the first filer, prior to the entry of the second licensed entry. The branded manufacturer can further sweeten the deal by offering a ?everse payment to the first filer. 7. Adderall is a Catch-22. The drug is designed to relieve symptoms of ADHD, but people with ADHD are at an increased risk of developing substance use disorders. They are more likely to make compulsive decisions and experience high levels of stress. COLCRYS is a trademark of Takeda Pharmaceuticals U.S.A., Inc., registered with the U.S. Patent and Trademark Office and used under license by Takeda Pharmaceuticals America, Inc. Aspen
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    • An Education in Ruin – Alexis Bass – 9781250195951
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