Category: General Biotechnology

Generic Drug Launch Dates – A 1-step Solution to Navigate the Web of Drug Patents and Regulatory Protections

Drugs can have many patents and regulatory protections Drugs can be covered by myriad patents and regulatory protections. Even Aspirin, which was first invented in 1853, has new patents. For…
The post Generic Drug Launch Dates – A 1-step Solution to Na…


Biosimilars in Developed and Developing East and Southeast Asian Countries: Japan, South Korea, and Malaysia—Overview, Evolution, and Regulations Assessment

This is paper was originally published in BioMed Research International, Volume 2016, by Tomas Gabriel Bas and Carolina Oliu Castillo under a Creative Commons Attribution License Abstract The development of…
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China and Potential Opportunity for Pharmaceutical Investments

Although many areas of contention exist in trade relations between the United States and China, ties are strengthening between the two countries, particularly in the areas of science and technology.…
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Affordability and availability of off-patent drugs in the United States—the case for importing from abroad: observational study

This article was originally published by Ravi Gupta, Thomas J Bollyky, Matthew Cohen, Joseph S Ross, and Aaron S Kesselheim  in BMJ 2018;360:k831 under a Creative Commons Attribution Non Commercial (CC BY-NC…
The post Affordability and availability of …


3 Uses for Historical Versions of the FDA Orange Book

Officially known as Approved Drug Products With Therapeutic Equivalence Evaluations, the FDA Orange Book contains a list of drugs considered by the FDA as both effective and safe. It does…
The post 3 Uses for Historical Versions of the FDA Orange Book …


What We Know From 4-Plus Years of Drug Patent Challenges Heard by the PTAB

While the Patent Trial and Appeal Board invalidates Orange Book-listed patents less than 20 percent of the time, it accepts 66 percent of petitions from generic drugmakers and takes no…
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Patents for Combination Products: Challenges and Opportunities

Combination products offer companies new directions for drug patent innovation. Medicine has become more personalized over the past generation, and this has affected the drug patent system. One major trend…
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Estimated costs of production and potential prices for the WHO Essential Medicines List

This article was originally published by Andrew M Hill, Melissa J Barber, and Dzintars Gotham in BMJ Global Health Jan 2018, 3 (1) e000571 under a Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license. Abstract Introduction There are persi…


Biobetters, Supergenerics Hold Many Advantages for Pharma Companies

By Larry Ramer, DrugPatentWatch writer A growing number of pharmaceutical companies are looking to simultaneously benefit from the low costs of developing generic treatments and the increased market share and…
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Biotech in Countries Starting with “I” – Part 12: Israel

This is a guest post from Susan K Finston, President of Finston Consulting.  A little over five years ago I penned the first installment in this irregular series, focused on Israel’s tech transfer prowess and efforts to encourage innovative life-sciences. I tracked the Start-Up Nation’s incremental progress here.    In a nutshell, Israel leveraged excellence in basic science and […]


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