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
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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)…
Historic drug sales data can help with market sizing. By examining sales trends over time you can gauge the attractiveness of the market entry. For patented drugs examining sales trends…
In evaluating generic entry opportunities many factors must be considered. DrugPatentWatch has comprehensive resources to aid in evaluating patent and regulatory constraints, and those are described in further detail in…
The generic pharmaceutical industry exists at the intersection of business, science, law, and government regulation. To be perform well in any of these disparate areas requires deep specialization (e.g. a…
Generic Pharmaceutical Patent and FDA Law covers Food and Drug Administration approval of generic drugs and the interaction of patents and FDA law. Some books in this space are written…
This article was originally published by Philippe Lahorte in World Patent Information Volume 54, Supplement, September 2018, Pages S18-S22 Under a Creative Commons license. Abstract This article provides an insight…
We thought you might be interested in some of the great reviews we’re getting over at software review site G2Crowd. Take a look at a few of the reviews below:…