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DrugPatentWatch serves leading companies ranging from biopharmaceutical R&D to healthcare delivery, and has been cited by CNN, NEJM, Nature Journals, and many other leading publications. Use cases for the DrugPatentWatch platform include: - Branded pharmaceutical global business intelligence and forecasting - Generic drug and API manufacturer portfolio management - Wholesalers preventing overstock of off-patent drugs - Healthcare payer formulary management and budget management
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In the high-stakes world of pharmaceuticals, patents play a pivotal role in safeguarding intellectual property and ensuring a return on investment for drug developers. The journey of a drug patent is a complex and intricate one, spanning from the initial filing to its eventual expiry. This article delves into the nuances of this process, shedding […
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In the ever-evolving pharmaceutical landscape, savvy businesses are constantly on the lookout for untapped markets and lucrative opportunities. One area that has garnered significant attention is the realm of low-competition generic drugs. These are off-patent medications that, for various reasons, have yet to attract a significant number of generi…
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Branded generics are generic drugs that are marketed under a brand name by the manufacturer. These products contain the same active ingredients as their brand-name counterparts but are typically sold at a lower price point. Branded generics can be an attractive option for both consumers and pharmaceutical companies, offering cost savings while leve…
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A recent whitepaper by Hermann Mucke summarizes the steps to performing an FTO for drug repurposing: Overview An FtO analysis determines if a new product or process can proceed without infringing third-party intellectual property (IP) rights, especially patents. It is crucial for drug repurposing projects involving known compounds that may still be…
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The article “The devil is in the divisional: an analysis of divisional patents, deadlines, declarations and suggestions for future practice” by Mieke Filler provides a comprehensive analysis of the strategic use of divisional patents in the pharmaceutical sector to delay generic and biosimilar market entry. Key Points Citations:[1] https://academic…
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Pharmaceutical companies employ various strategies to extend the commercial life and patent protection of successful drugs. Here are some key approaches with examples: New Formulations One common strategy is to develop and patent new formulations of the existing drug compound to provide benefits like reduced dosing frequency, easier administration,…
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Sure, here’s a more detailed explanation with examples: Drug Patent Duration Drug patents are granted by the United States Patent and Trademark Office (USPTO) for a period of 20 years from the date of filing the patent application. However, the effective commercial life of a drug patent is often much shorter due to the lengthy […]Source…
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In the “Patent Effect” podcast, Mustafa introduces his guest, Hakan Yum, the IP Director of Exrain Pharma, based in Sweden. The focus of the discussion is on patent litigation strategies within the pharmaceutical industry, particularly concerning biosimilars versus generics and the complexities involved. Hakan begins by distinguishing between gener…
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In a recent study published in the Expert Review of Medical Devices, researchers investigated the utilization of patent term extensions (PTEs) to extend regulatory timeframes for medical devices in the United States. Here are the key takeaways from their findings: Key Points: Overall, the study provides valuable insights into the evolving landscape…
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Drug repurposing, or identifying new therapeutic uses for existing drugs, is gaining significant momentum as a promising approach to accelerate drug development and reduce costs. This book chapter provides a comprehensive overview of the principles, strategies, and real-world examples of successful drug repurposing efforts. The chapter highlights s…
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The pharmaceutical industry in China is undergoing a significant transformation with the adoption of artificial intelligence (AI) technology. A recent study published in the Future Journal of Pharmaceutical Sciences evaluates the impact of AI on drug discovery and pharmaceutical product development in China. The research highlights the benefits and…
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A paper presented at the 2nd International Conference on Systems Medicine, AI, and Drug Repurposing proposes a novel approach to overcoming the financial barriers associated with repurposing generic drugs through interventional pharmacoeconomics (IVPE) and outcomes-based contracts. It highlights the challenges of funding clinical trials for repurpo…
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A recent study published in JAMA Health Forum sheds light on the impact of biosimilar competition on patient out-of-pocket (OOP) costs for biologic drugs in the United States. The research, conducted by Dr. Kimberly Feng and colleagues, aimed to investigate whether the introduction of biosimilars led to lower OOP spending for patients using biologi…
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A recent article in Communications of the ACM explores opportunities for “Permissionless innovation” in pharmaceuticals. “Permissionless innovation” refers to the freedom to explore new technologies or businesses without needing prior approval. It has fueled rapid innovation in the IT industry through open APIs, platforms, and ecosystem development…
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LACTOSE-Free Medicines, 2024 is part of DrugPatentWatch’s deep library of business intelligence on biopharmaceutical drugs. Buy Lactose-Free Medicines from Amazon This guide is designed to provide information for healthcare providers to assist patients in selecting suitable medications. Patients may ask healthcare providers to prescribe versions of…
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GELATIN-Free Medicines, 2024 is part of DrugPatentWatch’s deep library of business intelligence on biopharmaceutical drugs. Buy Gelatin-Free Medicines on Amazon This guide is designed to provide information for healthcare providers to assist patients in selecting suitable medications. Patients may ask healthcare providers to prescribe versions of d…
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Switching pharmaceutical excipients, the inactive components used in drug formulations, can have significant implications for both production costs and market appeal. These components, while not contributing directly to the therapeutic effect of a medication, play critical roles in the drug’s delivery, stability, and patient acceptability. The deci…
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Elevate your excipient business strategies with the comprehensive Drug Excipient Business Development Reports from DrugPatentWatch. Designed for excipient manufacturers seeking lucrative opportunities in the pharmaceutical industry, these reports offer invaluable insights to drive informed decision-making. Get the Excipient Reports from Amazon Empo…
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The recent paper published in PLOS ONE presents a novel approach for efficiently retrieving a substantial number of patents related to specific technologies. The authors enhance an automated patent landscaping algorithm by incorporating a manageable amount of human supervision to enhance result accuracy and consistency. The effectiveness of the app…
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A recent article published in Health Affairs, delves into the Federal Trade Commission’s (FTC) concerns regarding the inclusion of improper patents in the FDA’s Orange Book by pharmaceutical manufacturers. The Orange Book, which lists FDA-approved drugs along with associated patents, serves to notify generic drug manufacturers of existing intellect…
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A recent article published in the Journal of Cheminformatics addresses the challenge of confirming the patent status of newly developed compounds, particularly in the pharmaceutical industry, where generating novel structures is crucial for drug production. The article emphasizes the significance of developing compounds with novel structures for ne…
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A recent story by NPR echoes the findings of a collaboration between DrugPatentWatch and Bloomberg, which examined increasing competition between generic drug makers. The NPR article discusses the challenges in the generic drug industry, focusing on how rock-bottom prices contribute to shortages in hospitals. It highlights the closure of the Akorn …
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The article “Settled: Patent characteristics and litigation outcomes in the pharmaceutical industry,” explores the relationship between Paragraph IV litigation characteristics and the probability of a Paragraph IV settlement in the pharmaceutical industry, particularly focusing on the impact of patent characteristics on settlement outcomes. Summary…
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In the ever-evolving landscape of the biotech and pharmaceutical sectors, accurate valuation of post-revenue drug assets stands as the linchpin for informed and strategic decision-making. The significance of this valuation extends beyond the boardrooms of pharmaceutical companies to encompass venture capitalists, private equity firms, and regulator…
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Researchers from West Virginia University College of Law have conducted a study examining the frequency of drug patent invalidations based on inequitable conduct. The findings, published in JAMA, shed light on the impact of fraud or deceit in obtaining patents related to Food and Drug Administration (FDA)-regulated products. The study reveals a sig…
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In a recent article in Pharmaceutical Executive, Alan Kalton, Senior Vice President of Commercial Strategy at Aktana, sheds light on the critical challenges facing pharmaceutical companies as they confront impending drug patent expirations and escalating costs in the United States market. With a journalistic perspective, this report delves into the…
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Maximizing Intellectual Property Value in the Biomedical Sector: A Case Study on Rucaparib Patents
A paper titled “Analysis of Strategy for Extending Patent Protection of Rucaparib” by Zhifeng Wang. discusses the strategies employed by pharmaceutical companies to extend the patent protection period of the drug Rucaparib. Rucaparib is a medication used in the treatment of ovarian cancer and is subject to various patent strategies. The article hig…
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Advancements in In Silico ADMET Modeling: A 20-Year Journey of Machine Learning in Drug Discovery at Bayer Pharma
Over the past two decades, Bayer Pharma has developed an in silico absorption, distribution, metabolism, and excretion (ADMET) platform with the aim of generating models for various pharmacokinetic and physicochemical endpoints in early drug discovery. This platform is accessible to all scientists within the company and has proven valuable in assis…
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DrugPatentWatch has published a list of research papers citing DrugPatentWatch at https://www.drugpatentwatch.com/citations/ DrugPatentWatch.com is your key to unlocking the world of pharmaceutical research. These primary literature citations can benefit researchers, keeping them informed and connected in the ever-evolving field of drug patents. Re…
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In a systematic review titled “Influencers of Generic Drug Utilization,” researchers aimed to shed light on the key factors influencing the use of generic prescription drugs in the United States. The review, published in the journal Research in Social and Administrative Pharmacy, delves into the critical need to encourage the adoption of generic dr…
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The article titled “Reviving an R&D Pipeline: A Step Change in the Phase II Success Rate” discusses Pfizer’s efforts to improve its research and development (R&D) productivity. The pharmaceutical industry has faced declining R&D productivity, and Pfizer aimed to address this challenge by focusing on three key areas: biology, modalities, and decisio…
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The FDA conducted a study to identify factors that may predict the likelihood of generic drug marketing applications. The study focused on abbreviated new drug applications (ANDAs) submitted to the FDA, relying on existing reference (approved) drug products. The researchers analyzed data for 400 brand-name drugs, of which 140 were new chemical enti…
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“Measuring Patent Value Indicators with Patent Renewal Information” aims to address the research gap by constructing a dynamic model that incorporates both ex ante and ex post patent value indicators. The study focuses on a large set of pharmaceutical patents granted by the European Patent Office between 1996 and 2009. The authors test five ex […]S…
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The article “Maximizing the Value of Drug Patents Before Losing Exclusivity” discusses strategies for biomedical companies to maximize the value of their drug patents before the exclusivity period expires. In the world of medical and biotechnology companies, losing exclusivity on a drug patent doesn’t have to mean the end of profits. When a new dru…
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In a recent STAT article Sanofi CEO Paul Hudson discusses the potential of artificial intelligence (AI) in the pharmaceutical industry. While some in the industry have been hesitant to embrace AI, Hudson believes it can greatly benefit pharmaceutical companies. He highlights two approaches to AI adoption: “Expert AI” and “Snackable AI.” 1. Expert A…
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In the world of patents, the right to exclude others from using or selling an invention is granted only during the patent’s validity. Once a patent expires, this exclusivity vanishes. However, there is a way to extend a patent’s term, and it’s known as “Patent Term Extension” or “PTE.” PTE is specifically available for certain […]Source…
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Pharmacists play a crucial role in drug repurposing due to the vast amount of opportunities that exist in this innovative approach. Drug development and registration can be costly, time-consuming, and associated with high failure rates in clinical trials. Drug repurposing offers a creative and cost-efficient method to find new indications for medic…
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In a guest column Kevin Wall, principal consultant and owner of Cincero Consulting, emphasizes the critical importance of selecting the right Contract Development and Manufacturing Organization (CDMO) for drug product development. Small and virtual pharmaceutical companies often outsource their product and process development, making the selection …
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Loss of exclusivity (LOE) doesn’t have to spell doom for branded drug revenue streams. In the face of impending patent expirations, pharmaceutical companies can adopt key approaches to preserve meaningful value well into the post-patent-loss future. Traditionally, LOE has led to a sharp decline in sales for small molecule drugs, with brand unit sha…
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A recent paper in Expert Opinion on Biological Therapy studies failed fillings for biosimilar drugs. Over the past three decades, biotherapeutics have revolutionized healthcare by providing effective treatments for complex diseases that were previously challenging to manage with traditional small molecule pharmaceuticals. With the expiration or imm…
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DrugPatentWatch now offers single drug reports for purchase on Amazon. These reports provide valuable insights and information about specific drugs. This convenient availability on Amazon allows users to easily access detailed data about individual drugs, aiding in research and decision-making processes. Whether you’re a healthcare professional, re…
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A recent paper published in the journal “Intelligent Medicine” article discusses various aspects of using AI and machine learning in the pharmaceutical industry for drug discovery and development. Results The results section of the article presents specific findings related to the application of AI and machine learning in drug discovery and develop…
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A recent study explores the landscape of authorized generics in the United States pharmaceutical market. Authorized generics are brand-name drugs that are marketed without their original branding. The article sheds light on the trends, launch timing, and characteristics of these authorized generics in comparison to traditional generics. Authorized …
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A recent update from Foley & Lardner attorney Courtenay C. Brinckerhoff discusses trends in Inter Partes Review (IPR) and Post Grant Review (PGR) proceedings involving Orange Book and biologic patents, based on a report released by the USPTO. The main points highlighted are as follows: 1. Trends in AIA Petitions The number of AIA petitions challeng…
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In a recent Insight article published by Global Competition Review, legal experts from Lowenstein Sandler LLP delve into the status of reverse payment cases against pharmaceutical companies. Reverse payment cases arise from settlement agreements between brand-name pharmaceutical firms and generic drug manufacturers to resolve patent litigation unde…
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In the world of prescription drugs, brand-name manufacturers have employed various strategies to maintain revenue streams in the face of generic competition. One such strategy is the use of “authorized generics” (AGs) – essentially the same drug sold under a generic name, often at a slightly discounted price. This tactic came into the spotlight in …
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Review of 505(b)(2) Drug Products Approved by USFDA from 2010 to 2020: A Focus on Intellectual Property and Regulatory Considerations
A review article in the Journal of Pharmaceutical Sciences analyzes the trends in drug repurposing through the 505(b)(2) pathway, as approved by the USFDA from 2010 to 2020. The study aims to shed light on the challenges related to intellectual property (IP) protection and regulatory approvals faced during the development of reformulated and combin…
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Here’s a summary of a new article that used DrugPatentWatch data: NIH Funding for Patents That Contribute to Market Exclusivity of Drugs Approved 2010–2019 and the Public Interest Protections of Bayh-Dole examines the relationship between National Institutes of Health (NIH) funding and patents that provide market exclusivity for drugs approved from…
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In a recent article published by IAM Magazine, titled “Why Pharma Companies Should File Patents Later In The R&D Process,” Alexander R. Trimble, PhD, a prominent patent attorney, explores the optimal timing for pharmaceutical companies to file patents related to clinical trials. Trimble challenges the conventional practice of filing patent applicat…
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DrugChatter recently launched as an experimental AI chat-based business intelligence tool. Here’s some of the more interesting questions it’s been asked: Cost savings for bulk lipitor Who Invented Advil? What is the patent expiry date for Keytruda? How much cheaper is generic advil Are there any studies on the long term effects of lurbinectedin Wha…
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