Category: Insights

Review of Drugs Approved via the 505(b)(2) Pathway: Uncovering Drug Development Trends and Regulatory Requirements

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/…


Make Better Decisions: Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

BIO Attendees – Get a free preview of our book when it launches on July 1st Name Email HP Make Better Decisions helps generic and branded companies alike find and evaluate…
The post Make Better Decisions: Finding and Evaluating Generic and Branded Drug…


Formulary Management and LCM Patent Strategies: A Complex Interaction

Drug patent expiration doesn’t always mean generics enter the market right away. Many factors affect generic drug launches and drug formulary changes.
The post Formulary Management and LCM Patent Strategies: A Complex Interaction appeared first on Drug…


5 Steps to Take When Your Drug Patent is About to Expire

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.
The post 5 Steps to Take When Your Drug Patent is About to Expire appeared first on Dru…


Will AI Help Challenge Drug Patents, or Strengthen Them?

Artificial intelligence is allowing chemists to find new way to synthesize drug molecules, and forcing drug developers to shore up their patent strategies.
The post Will AI Help Challenge Drug Patents, or Strengthen Them? appeared first on DrugPatentWa…


Does Drug Patent Evergreening Prevent Generic Entry?

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…
The post Does Drug Patent Evergreening Pre…


Review of Drugs Approved via the 505(b)(2) Pathway: Uncovering Drug Development Trends and Regulatory Requirements

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…


Review of Drugs Approved via the 505(b)(2) Pathway: Uncovering Drug Development Trends and Regulatory Requirements

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…


How to Use Drug Sales Data to Refine Your Channel Strategy and Improve Your Portfolio Management

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…
The post How to Use Drug Sales Data to Refine Your Channel Strate…


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