Loss of exclusivity doesn’t mean the end of the income stream for branded drugs. Here’s how drug companies can mitigate the effects of drug patent expiration.
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Review of Drugs Approved via the 505(b)(2) Pathway: Uncovering Drug Development Trends and Regulatory Requirements
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This paper was originally published by Ingrid Freije, Stéphane Lamouche, and Mario Tanguay in Therapeutic Innovation & Regulatory Science under a Creative Commons Attribution-NonCommercial 4.0 License (http://www.creativecommons.org/licenses/by-nc/4.0/) Abstract A 505(b)(2)…
Generic drug makers must tailor European market entry strategies to each country. Moreover, they must address the sequence in which they want to enter markets.
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Drug patent expiration doesn’t always mean generics enter the market right away. Many factors affect generic drug launches and drug formulary changes.
There’s no reason to assume that every branded drug will fall victim to the “patent cliff.” Actions taken before drug patent expiration can extend drug life cycles.
Artificial intelligence is allowing chemists to find new way to synthesize drug molecules, and forcing drug developers to shore up their patent strategies.
Recently a presentation by an Israeli patent examiner was brought forward in an argument against patent evergreening. In her presentation, the patent examiner claims that patent evergreening has the following…
Review of Drugs Approved via the 505(b)(2) Pathway: Uncovering Drug Development Trends and Regulatory Requirements
0
This article was originally published by Ingrid Freije, Stéphane Lamouche, and Mario Tanguay in Ther Innov Regul Sci. 2019 Jan 7:2168479018811889 under a Creative Commons Attribution-NonCommercial 4.0 License (http://www.creativecommons.org/licenses/by-nc/4.0/) Abstract A 505(b)(2)…