Drug Price Competition and Patent Term Restoration Act
2
MENTIONS
2
EPISODES
2
PODCASTS
Search complete. 2 mentions across 2 episodes found for "Drug Price Competition and Patent Term Restoration Act".
Sep 23, 2026
2026 Regulatory Updates And Operation TrialBlazer
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2:47Elizabeth TrentacostGUEST
Um, before that I was at FDA working in the Center for Drugs in the Office of Regulatory Policy.
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2:52Elizabeth TrentacostGUEST
While I was there, I handled, uh, citizen petitions, uh, Hatch-Waxman issues, exclusivity, a lot of collaboration with Offi- Office of Generic Drugs and the Office of Pharmaceutical Quality, um, answering regulatory questions from stakeholders, and anything that, that was needed of ORP.
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3:11Elizabeth TrentacostGUEST
Um, and at A&P I handle many of the same, um, types of policy, strategy, product development, um, compliance questions that come along.
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3:21Tyler MenichielloHOST
Awesome.
Protecting Psychedelic Innovation: IP, Patents, & Defensibility
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19:17Linnea CiprianoGUEST
You can also assert additional patents in that litigation related to the drug.
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19:23Linnea CiprianoGUEST
If you're only asserting manufacturing patents, then you probably wouldn't be able to get the benefit of the 30 month stay in the Hatch-Waxman statute.
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19:31Linnea CiprianoGUEST
Understood.
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19:32Ritu BaralHOST
Going back to use patents for a second.