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Drug Price Competition and Patent Term Restoration Act

Drug Price Competition and Patent Term Restoration Act

Search complete. 2 mentions across 2 episodes found for "Drug Price Competition and Patent Term Restoration Act".

Sep 23, 2026

Elizabeth TrentacostGUEST
2:47
Um, before that I was at FDA working in the Center for Drugs in the Office of Regulatory Policy.
Elizabeth TrentacostGUEST
2:52
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.
Elizabeth TrentacostGUEST
3:11
Um, and at A&P I handle many of the same, um, types of policy, strategy, product development, um, compliance questions that come along.
Tyler MenichielloHOST
3:21
Awesome.
Linnea CiprianoGUEST
19:17
You can also assert additional patents in that litigation related to the drug.
Linnea CiprianoGUEST
19:23
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.
Linnea CiprianoGUEST
19:31
Understood.
Ritu BaralHOST
19:32
Going back to use patents for a second.

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