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IPD has released a new Data STACK Trend Report: “An Examination of Factors that Influence Patent Exclusivity Retention of Brand Drugs.”

In this report, we analyzed 141 brand drugs across 40 manufacturers that either: (1) faced first-time generic entry from January 2018 through June 2024, (2) lacked generic competition as of June 2024 despite having no unexpired patents or exclusivity remaining, or (3) whose manufacturer launched an early authorized generic through an out-licensing agreement or in-house during the review period. The report reveals trends such as longer exclusivity retention for high-complexity drugs, the relationship between gross sales and retained exclusivity, and how brand manufacturers leverage composition-of-matter and formulation patents to extend protection.

IPD has released a new Data STACK Trend Report: “Trends in At-Risk Generic Drug Launches.”

In this report, we analyzed 27 brand drugs with peak gross sales totaling $25.7B that faced 51 separate at-risk generic launches from 29 different generic manufacturers between January 2017 and June 2024. Our analysts also identify 7 upcoming at-risk launch opportunities, representing a total of $13.6B in peak gross sales.

IPD Analytics has released its Biosimilar Pipeline Report, which provides insight on potential approvals and launches across the biosimilar landscape over the 2024–2027 horizon. Of the 21 drugs covered in the report, notable impacts to utilization, pricing, and market share are expected for Stelara, Xolair, Prolia, Soliris, Eylea, and Neulasta.

IPD Analytics has released its Drug Pipeline and Trend Impact Report 2H 2024, a semiannual publication that highlights late-stage pipeline drugs with the potential to significantly affect the competitive landscape and payer drug spend across trending drug classes.

For each of the 37 drugs IPD identified as having potentially high impact, the report provides an assessment of clinical efficacy and safety, expected place in therapy, approval outlook, estimated cost, and information regarding the reimbursement and distribution channel.

IPD’s team of experts—Jeff Casberg, MS, RPh, Leslie Fish, RPh, PharmD, Andy Levitsky, PharmD, BCPS, Steven Johnson, PharmD, Kate Cook, PharmD, CAHIMS, CMAS, and Scott Allen, JD—recently sat down to discuss the developments and challenges within the 340B drug pricing program, including perspectives from pharmaceutical manufacturers, payers, federal government, hospitals, and legal analysts. In addition, this episode provides insight into how recent court cases and proposed legislative actions might impact the 340B program.

IPD has released a new report, "Drug Shortages: Legislation and Proposed Regulatory Actions," which delves into the increasing number of drug shortages affecting both hospitals and retail pharmacies. The report highlights key legislative actions and federal proposals aimed at addressing this critical issue.

IPD has released a new podcast episode, “GLP-1 Drug Shortages and Compounding," where Alyssa Guest, PharmD, discusses the glucagon-like peptide-1 (GLP-1) drugs and how interest in weight loss, viral social media posts, celebrity endorsements, illegitimate compounding, and drug shortages have all impacted access to GLP-1s.

IPD’s new podcast release, "Insulins: Price Cut Aftermath and Pipeline Review," discusses the effects of the recent insulin price cuts by Eli Lilly, Novo Nordisk, and Sanofi, driven by the Inflation Reduction Act (IRA).

Our recent Primary Market Insights report summarizes insights from over 110 regional and national payer and health-system experts regarding biosimilar management strategy, the financial impact of biosimilars, and interchangeability. With input from vice presidents of pharmacy, pharmacy directors, clinical pharmacists, and purchasing/operations executives, the report examines how organizations are measuring biosimilar savings, planning for preferred products, covering Humira biosimilars, and reacting to price changes on long-acting insulin glargine products, and more.

IPD has released a new report that analyzes the consequences of the sole orphan drug exemption in the Inflation Reduction Act (IRA). Drug manufacturers and organizations such as NORD have stated that the sole orphan exemption will disincentivize drug companies from conducting further research to develop a rare disease drug for an additional indication. In addition, the report outlines other key pieces of legislation pertaining to rare diseases/orphan drug development and their potential impact, such as the ORPHAN Cures Act, the RARE Act, and the Creating Hope Reauthorization Act of 2024.

IPD’s recent Primary Market Insights report, “Obesity: Evolving Perceptions from Providers and Payers on Treatments for Chronic Weight Management,” analyzes the results from surveys completed by 30 primary care physicians and 30 endocrinologists to assess their prescribing preferences among anti-obesity medications (AOMs). These surveys capture early assessments of Eli Lilly’s Zepbound (tirzepatide) and Novo Nordisk’s Wegovy (semaglutide) for reduction in the risk of major adverse cardiovascular events (MACE) as well as anticipated usage of oral semaglutide.

IPD has released a new Data STACK report that analyzes 2024 drug price increases. Over the timeframe of our analysis, more than 700 brand drugs had price increases with an average of 5.4% (median, 5%), and approximately 40 generic drug prices increased by an average of 39% (median, 10%), based on wholesale acquisition cost (WAC). The report examines the top 3 therapeutic areas for price changes, notable brand and generic price increases and decreases, legislative and regulatory impacts, and more.

IPD has released a new Data STACK report focused on trends in court decisions involving Paragraph IV (PIV) certifications that were litigated to a final decision over the last 5 years. The report features 273 certifications that IPD reviewed and analyzed from the top 20 generic manufacturers that litigated the most PIV certifications to a final decision, from January 2017 through October 2023. Our Data STACK report dives into trends by manufacturer, jurisdiction, and patent type to reveal key themes that can help predict outcomes with greater certainty.

IPD has released its first report in a new series exploring complex drug analogs for formulation technologies, focusing on complex inhaled drugs. Complex inhaled drug products represent a new frontier in pharmaceutical development, offering innovative solutions for respiratory diseases.

IPD recently released a new report, “Savings Opportunities with Upcoming Specialty and Traditional Generics,” that highlights cost-savings opportunities related to key potential generic launches in 2024, noting drugs with significant sales volume.

The report also includes details on the generic outlook from patent and regulatory perspectives, important considerations for payers from a clinical perspective, and considerations for hospitals/health-systems (where relevant).

IPD Analytics has released its Drug Pipeline and Trend Impact Report 1H 2024, a semiannual publication that highlights late-stage pipeline drugs with the potential to significantly affect the competitive landscape and payer drug spend across trending drug classes.

For each of the 37 drugs identified as having potentially high impact, the report provides an assessment of clinical efficacy and safety, expected place in therapy, approval outlook, estimated cost, and information regarding the reimbursement and distribution channel.

IPD Analytics' Hospital Inpatient Pipeline Therapies Report for 2024 focuses on potential approvals and launches that will impact hospitals and health-systems in the near term.

This report offers hospital pharmacy leaders visibility into potential FDA approvals for budget planning purposes for the current fiscal year. The delineation of pipeline therapies into hospital inpatient, professionally administered, and self-administered specialty categories enables pharmacy leaders to stratify the potential costs and revenue from new product launches by type of service.

IPD’s semiannual Biosimilar Pipeline Report for 1H 2024 provides an outlook for potential approvals and launches across the biosimilar landscape over the 2024–2027 horizon.

The report covers pipeline drugs, average sales price (ASP) trends, and 2023 approvals.

IPD has released a new report, “PBM Drug Exclusion List Changes for 2024,” covering changes in the 2024 drug exclusion lists from the three largest pharmacy benefit managers (PBMs): Express Scripts, Optum Rx, and CVS Caremark.

This report examines potential motivations and trends underlying the changes to PBMs’ drug exclusions lists in 2024.

IPD Analytics has released a Trend Report as part of our Data STACK subscription that analyzes 444 generics launched between January 2019 and September 2023 by the top five generic manufacturers (Aurobindo, Amneal, Teva, Sun, and Hetero). In the report, we explore trends around filings, launch timing, pricing, market share, and projected competition among these five manufacturers...

IPD Analytics has released a Trend Report as part of our NEW Data STACK subscription that analyzes 151 authorized generics launched between January 2019 and July 2023 in the United States. In the report, we explore trends around authorized generics and their top manufacturers, launch timing, market share, and origins through settlements, subsidiaries, and partnerships...

In India, patent litigation can simultaneously move through a number of courts, all of which can impact loss-of-exclusivity timing. The multiplicity of proceedings makes it critical to be physically present in the courtroom to understand and analyze the legal proceedings in which a drug may be involved...

IPD Analytics has released a Trend Report as part of our NEW Data STACK subscription that evaluates the relationship between first-to-file NCE−1 ANDAs and peak sales of brand drugs. In the report, we analyzed a total of 263 first-to-file ANDAs since January 2019 to evaluate the correlation between ANDA filings and peak annual sales volume of the referenced brand drugs...

In this report, IPD Analytics provides detailed summaries of key drugs nearing potential FDA approval in the coming months. Our team of pharmacists, PhD scientists, and intellectual property attorneys continuously monitor and update our comprehensive pipeline intelligence database...

The Japanese patent linkage and regulatory systems are opaque and often misunderstood. IPD Analytics explains and analyzes these systems in the context of a case study (tafamidis). ). Learn more about patent term extensions, regulatory exclusivity, timing of approvals, NHI price listing, and much more.

Delayed generic competition may become a reality for up to 23 brand drugs in Mexico after the Supreme Court’s landmark Nexavar decision. With our Mexican Life-Cycle Insights coverage, we have identified a number of patent term adjustment applications and appeals involving pharmaceutical patents that may see their terms extended...

IPD's Executive Clinical Pharmacy team discusses the pipeline for the nonalcoholic steatohepatitis (NASH) space, including epidemiology and prevalence, methods of diagnosis, pipeline treatments, and more.

In this report, IPD outlines the drug selection process and provides lists of potential selected drugs that we predict will be selected by Medicare for price negotiation based on the criteria outlined by CMS. We also include our rationale for excluding certain drugs from selection. The report includes drugs that may meet the criteria for initial price applicability in 2026, 2027, and 2028.

Drug shortages are an often unpredictable challenge that can be a result of multiple issues along the supply chain. Oncology drugs, including both chemotherapeutics and supportive care medications, are often affected.

Oncology drug shortages can result in delayed chemotherapy treatments, changes in dosing, use of alternative regimens, or even missed doses, if one or more drugs required as part of a treatment regimen is not available...

The Orphan Drug Act defines a rare disease as a disease or condition that affects less than 200,000 people in the United States. The FDA grants the Orphan Drug designation (ODD) to products that could be used to treat a rare disease. While drugs receiving the ODD can qualify for special incentives, they are still subject to the typical FDA review process...

In this report, IPD Analytics provides detailed summaries of key drugs nearing potential FDA approval in the coming months. Our team of pharmacists, PhD scientists, and intellectual property attorneys continuously monitor and update our comprehensive pipeline intelligence database...

​Use this report as a companion to our online Payer & Provider Insights and Clinical Development Tracker areas, which provide up-to-date clinical pipeline information on thousands of products across various disease classes and therapeutic areas. In tandem, these reports deliver insight into trending classes that will affect the competitive landscape and your drug spend.

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Cognitive behavioral therapy (CBT) is a type of psychotherapy that focuses on changing current behavior without attempting to determine or evaluate why the behavior exists. CBT is effective in treating depression, anxiety disorders, addiction, eating disorders, and even digestive conditions such as irritable bowel syndrome (IBS)...

Amylyx’s Relyvrio (sodium phenylbutyrate and taurursodiol; formerly AMX0035) is an oral, fixed-dose combination therapy approved by the FDA on September 29, 2022, for the treatment of amyotrophic lateral sclerosis (ALS). Relyvrio is designed to target the endoplasmic reticulum and mitochondrial-dependent neuronal degeneration pathways...

The 2023 launch of biosimilar versions of AbbVie’s Humira (adalimumab) will represent the largest loss-of-exclusivity event in the history of pharmaceuticals (based on Humira’s annual sales of over $20B) and one of the most important formulary management and financial decisions for payers, pharmacy benefit managers (PBMs), and hospitals in recent memory...

IPD Analytics’ 360° Insights provide a comprehensive analysis to help you examine products and companies from every angle. These synchronous reports across IPD’s multiple platforms aggregate our analyses of intellectual-property protection, clinical data, payer reimbursement, and financial outlook, providing a 360° view of the market landscape...

The utilization of digital therapeutics (DTx) has increased in recent years, especially since the start of the COVID-19 pandemic. With the growing interest in DTx, manufacturers have increased their investments in this space, and there is a robust pipeline of DTx products...

As the affordability of prescription drugs continues to be a top concern for consumers in the United States, drug importation, the practice of importing prescription drugs from another country, has been proposed as an approach to reducing drug costs...

Our Executive Clinical Pharmacy team talks through the complement inhibitor drug class and pipeline, including current approvals, side effects, and manufacturer challenges.

In IPD’s latest report, Brand Drugs with Expected Generic Competition in Canada in 2H 2022–2024, our Canadian legal and regulatory analysts identify 36 brand-name small-molecule drugs covered by data protection or patent portfolios for which the generic competition likely would begin during 2H 2022–2024...

The Inflation Reduction Act of 2022 is a budget reconciliation bill that addresses drug prices, corporate taxes, climate change, and energy security. It was passed by the U.S. Senate on August 7, 2022, passed by the U.S. House of Representatives on August 12, 2022, and signed into law on August 16, 2022, by President Biden...

IPD Analytics’ 360° Insights help you analyze products and companies from every angle with aggregated, synchronous updates across our multiple platforms. Together, the full reports from each platform provide a comprehensive, 360° view of the market landscape...

In this report, our legal and regulatory analysts provide a background on patenting antibodies at the European Patent Office (EPO) and its member states. We then synthesize and analyze multiple case studies involving the validity and potential infringement of broad, functionally defined antibody patents...

Our Executive Clinical Pharmacy team talks through the basics of patient financial assistance programs and their impacts on the healthcare space, including coupons and copay programs, free-trial programs, bridge programs, and more.

The FDA’s Priority Review Voucher (PRV) program was designed to incentivize the creation of medications for unmet needs and underserved disease areas...

In this report, we explore recent trends in ANDA submissions one year prior to the expiration of New Chemical Entity (“NCE”) exclusivity associated with a referenced branded drug, referred to as the “NCE-1 date...”

In this report, IPD explores recent trends in ANDA submissions one year prior to the expiration of New Chemical Entity (“NCE”) exclusivity associated with a referenced branded drug, referred to as the “NCE-1 date...”

Our Executive Clinical Pharmacy is back to add more insight on limited distribution drugs and their networks. As the specialty drug landscape has expanded, payers and providers have struggled to stay up to date on shifting limited distribution networks, making it harder to provide these critical medicines to patients. IPD's team discusses this complexity and why it's important to track limited distribution networks.

Our Executive Clinical Pharmacy team talks through strategies for maximum revenue capture at a time when hospitals are trying to keep up with COVID-19 related admissions, while seeing less revenue coming in from elective procedures and changes to the 340B program are looming.

Our Executive Clinical Pharmacy is back to add more insight on limited distribution drugs and their networks. As the specialty drug landscape has expanded, payers and providers have struggled to stay up to date on shifting limited distribution networks, making it harder to provide these critical medicines to patients. IPD's team discusses this complexity and why it's important to track limited distribution networks.

Our Executive Clinical Pharmacy Team discusses the basics of generic and brand drug pricing and reimbursement, including brand pricing terms and acronyms, brand pricing differences based on dispensing method, specialty spread pricing, MAC lists, NDC codes, medically covered drugs,
methodologies for medical drug reimbursement, and more.

Authorized generic (AG) drugs have existed for more than 40 years and have long been utilized as a life-cycle management strategy by manufacturers to compete with generics...

Our Executive Clinical Pharmacy Team discusses 505(b)(2) products and how they compete in the marketplace alongside brand and generic drugs, tackling pricing, market access, and stakeholder implications.

Over the past several years, the pharmaceutical industry has shifted away from traditional small-molecule drugs to focus more on complex formulations and specialty agents. The additional market complexities that are accompanying this shift have impacted stakeholder strategies for all drugs facing loss of exclusivity...

Our Executive Clinical Pharmacy Team discusses Authorized Generics (AGs) and their impacts across the marketplace., including motivations for launch, positioning tactics, impacts on erosion and uptake, forecasting implications, and more.

Our Executive Clinical Pharmacy team explains manufacturer life-cycle management strategies, including specific examples of successes and failures. Strategies explored in this episode include additional indications, bundling, brand over generic strategies, co-pay assistance programs, and more.

What does a recent case decided by the Federal Circuit Court mean for brand and generic manufacturer strategy in the future? Our Insight Brief reveals a subplot with potentially high stakes for payers, providers, and patients alike...

IPD experts take you through the basics of how P&T Committees work to plan their formularies, including goals, members, clinical and financial reviews, formulary tiering, planning trends, and more.

Our clinical pharmacists and and former Federal Circuit Clerks take you through the basics of skinny labels and off-label drug use, including definitions and motivations, examples, regulation, and more.

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