
Acquire actionable intelligence on the commercial dynamics of bio pharma drugs, focusing on drug patent expiration, generic entry, and strategic guidance across the drug development and delivery value chain.
Meet a biotechnology pioneer: founder of Think Biotech and publisher of Drug Patent Watch. Share his experience teaching biotechnology management at NIH, Johns Hopkins University, and National Defense University.
Explore DrugPatentWatch, a global biopharma business intelligence platform offering patents, litigation, pricing, and historical sales data across 134 countries to anticipate generic entry and competitive dynamics.
Discover a free companion text that helps generic and branded drug companies evaluate patent expiry, strengthen patents, challenge patents, plan generic market entry, and locate proprietary settlements and deal terms.
Treat this course as educational and informational, not as legal or investing advice. Seek guidance from a qualified attorney or expert for legal questions.
Explore the differences between small molecule and biologic drugs, highlighting oral dosing versus injection, stomach absorption, cold-chain requirements, manufacturing costs, and the generic versus biosimilar landscape.
Explore regulatory differences between generic and biosimilar drugs, including FDA criteria for identical active ingredients and strength, interchangeable substitution, and how biosimilars require high similarity and manufacturing nuance.
Explore how the United States market drives generic drug entry via patent linkage, FDA Orange Book listings, and paragraph certifications that determine when generics can launch.
Discover 505(b)(2) drugs, a hybrid of generics and branded drugs that borrow NDA safety data and add new investigations, amendments, and changes to dosage form, strength, or indications.
Explore how patents and other forms of intellectual property protect drug development, summarizing patents, trade secrets, trademarks, and copyrights, and define novelty, usefulness, non-obviousness, and disclosure requirements.
Protect trademarks to identify manufacturers and distinguish drug products, preserving brand value after patent expiry, including names, colors, and look-and-feel that set branded from generic medicines.
Explore regulatory exclusivity, including new chemical exclusivity, new clinical investigation exclusivity, pediatric exclusivity, orphan drug protections, and biosimilar protections, and how they interact with patents and FDA timelines.
Examine patent structures, including the cover page and specification, identify claim types from compound to use claims, and explore litigation, patent linkage, and generic entry strategies in biopharma.
Analyze branded drug launch decisions, including market size, price, launches, and lag across countries. Examine lifecycle management with patents, regulatory exclusivity, and strategies like new formulations, combinations, and authorized generics.
Explore how generics reduce medicine costs. Learn the factors shaping generic entry decisions and strategies like first-mover advantage, authorized generics, and day-181 entry.
Conclude by reinforcing how generic drug portfolio management and branded drug lifecycle management intersect with patents and regulatory factors in drug and commercial strategies.
Identify and evaluate generic market entry opportunities for GMP and related sectors, using litigation-free launch strategies, five-a to five-b2 pathways, authorized and branded generics, and channel-aware pricing.
Explore how to evaluate innovative portfolios and anticipate generic entry, including first-mover dynamics, branding strategies, and lifecycle tactics to extend brand value amid competition.
Explore strategies for identifying generic market entry opportunities, including patent landscapes and first-mover advantages, while evaluating brand partnerships, authorized generics, and packaging differentiation to stay competitive.
GET INSIGHTS INTO THE BIGGEST REVENUE-CHANGING EVENTS
By tracking patent expirations, patent litigation, generic and biosimilar development, you can anticipate these market-shaping forces and stay one step ahead.
Branded drug companies can experience precipitous revenue erosion as generic drugs rapidly gain market share. All the while patients, physicians, payers, pharmacists, and other healthcare stakeholders must race to keep up.
This course answers the following questions to help you adapt:
When will key drug patents expire?
How can I write stronger patents?
How can I defeat drug patents?
How can I find, evaluate, and plan for generic market entry opportunities?
How can I find proprietary out-of-court settlements and deal terms?
Comprehensive and actionable coverage of commercial, legal, and regulatory factors builds a solid foundation for strategic thinking. Diverse case studies build on this groundwork by analyzing and explaining real-work examples to form the underpinning for your tactical plans.
*INCLUDES FREE COMPANION TEXTBOOK
This course is the product of more than twenty years of providing guidance to drug development companies and other healthcare stakeholders.
Through developing the first website on the business of biotechnology in the 1990s (now owned by the New York Times), editing and publishing the Journal of Commercial Biotechnology, and leading data analytics for a subsidiary of Scientific American, I have had the fortune of spending considerable time at the bleeding edge of the commercial side of drug development.
The motivation to develop this course comes from my experiences running DrugPatentWatch, a comprehensive platform to help identify and evaluate opportunities around drug patent expiration and generic entry. In the early 2000s the first version of DrugPatentWatch was developed in response to repeated requests to answer the simple question: “When do drug patents expire?” As the platform matured, it became apparent that there was a strong need for a single source integrating broad strategic guidance to help stakeholders throughout the drug development and delivery value chain. This course was designed to meet that need.
As with my other publications, the focus of this course is on actionable intelligence. Because the legal and regulatory underpinnings of drug development and delivery are complex and change frequently, the approach taken by this course is to explain the current state of affairs and to provide representative examples to help you develop a deep understanding so you can quickly adapt to and capitalize on future events.
A primary objective of this course is to fill gaps in knowledge, helping you leverage your expertise, without being overly exhaustive. For readers seeking greater technical depth I provide links to some of the books and web-based resources that I found helpful.
Because strategic planning for branded drugs has many similarities to finding and prioritizing generic entry opportunities, this course has relevance for generic and branded companies alike. Likewise, distributors, payers, investors, and myriad other stakeholders will also benefit by understanding the commercial dynamics of pharmaceutical and biotechnology drugs.
I hope you enjoy this course as much as I did putting it together.
About the Author:
Yali Friedman, Ph.D. has more than 20 years experience providing business intelligence to life science companies. He was recently named one of the 100 most influential people in biotechnology by Scientific American. He is also author of the MBA-level textbook Building Biotechnology and publisher of the Journal of Commercial Biotechnology.