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U.S. Insights: Trends in First-to-File NCE-1 ANDAs Based on Peak Estimated Brand Drug Sales
August 2023
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.
Our experts leverage the datasets housed within Data STACK to draw insight from stats, trends, analogs, and company profiles to develop Trend Reports that provide a deep dive into pipeline dynamics, approvals, litigation, sales, pricing, rebates, formulary trends, and market access metrics. Dive into the data and insights now:
Indian Life-Cycle Insights Case Study: Trajenta and Trajenta Duo
Simultaneous Litigation Events in Courts Across India and the Effect on Generic Entry
August 2023
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. Through our latest report on Boehringer Ingelheim’s Trajenta (linagliptin) and Trajenta Duo (linagliptin/metformin hydrochloride), learn how the same drug was litigated for patent infringement and revocation actions in the Delhi, Bombay (Mumbai), Himachal Pradesh, Telangana, and Madras (Chennai) High Courts by various generic drug manufacturers.
Trends in Recent Authorized Generic Launches, 2019-2023
September 2023
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.
Our experts leverage the datasets housed within Data STACK to draw insight from stats, trends, analogs, and company profiles to develop Trend Reports that provide a deep dive into pipeline dynamics, approvals, litigation, sales, pricing, rebates, formulary trends, and market access metrics.
Profile Trends for Top Five Generic Manufacturers, 2019–2027
October 2023
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. In addition, through 10 generic launch case studies, we look at the unique relationship between generic pricing and the level of generic competition.
Our experts leverage the datasets housed within Data STACK to draw insight from stats, trends, analogs, and company profiles to develop Trend Reports that provide a deep dive into pipeline dynamics, approvals, litigation, sales, pricing, rebates, formulary trends, and market access metrics.
Drug Pipeline Report: 2H 2023
August 2023
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.
Japanese Life Cycle Insights
Case Study: Vyndaqel, Vynmac (Tafamidis)
An Overview Of The Patent And Regulatory Landscapes
July 2023
Biosimilar Pipeline Report
2H 2023
In this report, IPD Analytics provides an outlook for potential approvals and launches across the biosimilar landscape over the 2023–2027 horizon.
Our team of pharmacists, PhD scientists, and intellectual property attorneys continuously monitor and update our comprehensive pipeline intelligence database.
Subscribers use this report as a companion to our online Clinical Development Tracker within our Payer & Provider Insights platform, which provides 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.
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 with IPD's Japanese Life-Cycle Insights coverage.
Mexican Life-Cycle Insights: Delayed Generic Competition May Become a Reality after Supreme Court's Nexavar Decision
July 2023
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. In view of the Nexavar decision, due to the Mexican Patent Office’s delay in the examination of applications that issued as patents while the North American Free Trade Agreement was in force, these patent term adjustment applications could extend the expiration dates of these patents until the latter of 20 years from the first filing date of the underlying application or 17 years from the patent’s issuance date.
The Inflation Reduction Act (IRA) of 2022 established the Medicare Drug Price Negotiation Program as part of its aim to lower prescription drug prices. Through this program, the U.S. Department of Health and Human Services (HHS), via the Centers for Medicare and Medicaid Services (CMS), intends to establish a maximum fair price for certain high-expenditure, single-source Medicare drugs.
CMS has indicated it plans to publish the first 10 Medicare Part D drugs that will be eligible for negotiation under this program by September 1, 2023, with the negotiated prices for selected drugs published by September 1, 2024, and prices becoming effective starting January 1, 2026 (i.e. initial price applicability year 2026).
We note that timing may be impacted by potential litigation between manufacturers and the U.S. government. On June 7, 2023, Merck filed a lawsuit against CMS, HHS, and the Secretary of HHS challenging certain elements of the IRA. We expect additional manufacturers may file lawsuits in the months ahead.
In this report, we outline the drug selection process and provide IPD Analytics’ 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 in Oncology
February 2023
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.
To prepare for shortages, it is vital for health-systems, providers, and payers to stay up to date using both the American Society of Health-System Pharmacists’ (ASHP’s) and the U.S. Food and Drug Administration’s (FDA’s) drug shortage lists. Payers should be aware of shortages of drugs that are included in prior authorization (PA) or step therapy programs in order to be able to select and cover an alternative when needed.
The report tackles how health-systems, providers, and payers can develop well-defined plans for managing drug shortages to prevent delays in therapy and maximize drug availability.
Rare Disease Drug Approvals - 2022 Year in Review
February 2023
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.
This report highlights 24 rare disease drug approvals from 2022, including three gene therapies. These products span eight therapeutic areas, with the most common being oncology.
Digital Therapeutics Using Cognitive Behavioral Therapy
January 2023
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). CBT can be provided via several modes of delivery, including face-to-face, telehealth, internet-based delivery, and now, DTx.
In this report, our Executive Clinical Pharmacists explore current DTx products that deliver CBT, payer coverage for various modes of CBT, and why payers should consider evaluating the cost-effectiveness and availability of CBT delivery modalities to determine the appropriateness of DTx coverage in light of other modes of CBT delivery that are already routinely covered.
Humira Budget Impact Analysis & Biosimilar Management Report
Published 2022
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.
Starting in late January 2023 and continuing through 2024, 14 or more biosimilar Humira products may launch, including both original-formulation (50 mg/mL) and new, high-concentration (HC) formulation (100 mg/mL) products. At this time, approximately 85% of the sales volume is in the new (HC) formulation. Several products are likely to launch with an interchangeability designation, although the significance of this designation for the product’s clinical or financial success with payers, pharmacies, hospitals, and manufacturers is unclear. It is likely there will be a wide range of pricing formats offered by AbbVie and biosimilar manufacturers for their products. Formulary decisions by payers and PBMs could significantly impact the financial performance of their pharmacy benefits over the next few years.
For hospitals that dispense Humira through 340B pricing, this conversion to biosimilar Humira may also impact financial performance. As additional intelligence is available, IPD Analytics will continue to update subscribers with information that may impact management decisions.
This report will help stakeholders in the industry understand the major topics surrounding this market shift, including biosimilar launch, pricing, and budget outlook, management opportunities, hospital reimbursement strategies, and more.
360° Insights: Amylyx's Relyvrio
December 2022
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. Amylyx is also investigating AMX0035 for the potential treatment of Alzheimer's disease and Wolfram syndrome.
ALS is a rare, fatal, progressive neurodegenerative disorder that affects upper and lower motor neurons. A loss of motor neurons in the brain and spinal cord initially leads to focal weakness, with muscle weakness spreading over time. Most patients die of respiratory failure within 2 to 5 years of symptom onset.
Currently, there are no treatments that stop or significantly slow the progression of ALS. Prior to the approval of Relyvrio, riluzole and Mitsubishi Tanabe’s Radicava/Radicava ORS (edaravone) were the only two drugs approved by the FDA to treat the disease; however, each of these three treatments has only been shown to provide a modest benefit.
Amylyx has initiated the Phase 3, placebo-controlled PHOENIX trial to evaluate the efficacy and safety of Relyvrio. Given that Relyvrio received a traditional approval from the FDA, confirmatory results from this trial are not required for ongoing approval. The results, however, will be of interest, as questions have been raised regarding Relyvrio’s efficacy. Herein, we provide a selection of key points included in our full reports.
360° Insights: Karuna Therapeutics' KarXT
October 2022
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.
Karuna Therapeutics is developing KarXT (xanomeline and trospium) for the treatment of schizophrenia and Alzheimer's disease psychosis. Xanomeline is a new molecular entity that has demonstrated antipsychotic and pro-cognitive properties; trospium is a muscarinic antagonist that offsets the peripheral cholinergic effects of xanomeline. Trospium was first approved as Allergan's Sanctura in 2004 for the treatment of overactive bladder.
Karuna has indicated that it plans to submit a New Drug Application (NDA) to the FDA for schizophrenia in mid-2023, which would allow for approval of KarXT sometime in 2024. The company has also indicated it will submit a supplemental NDA (sNDA) for use of KarXT as an adjunctive treatment for schizophrenia soon after filing for the monotherapy indication.
If approved, KarXT would be the first muscarinic agonist for the treatment of schizophrenia to enter the market. Herein, we provide a selection of key points included in our full reports.
Prescription Digital Therapeutics: Guide for Manufacturers
September 2022
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.
In this paper, we will focus on a subset of DTx products known as prescription digital therapeutics (PDTs), which are only available as a prescription through consultation with a healthcare professional. Currently, there are over 10 PDTs on the market, with more expected to enter the market within the next few years.
Although it is often difficult to ascertain the sales and utilization information for PDTs, we have drawn on our deep experience to outline the primary factors that we believe will determine the success of future PDT products. In addition to identifying these factors, we also provide specific guidance for manufacturers to consider in designing and marketing their PDT products.
U.S. Prescription Drug Importation
September 2022
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. Although several states have passed bills that establish drug importation programs, these cannot be implemented without first being authorized by the FDA. Since the FDA created the Final Rule, “Importation of Prescription Drugs” (effective as of November 30, 2020), there has been strong opposition from the pharmaceutical industry and reservations from stakeholders, based on safety concerns and lack of certainty around cost savings. Minimally, drug importation has the potential to lower prices for cash-paying patients. If implemented widely and if it is successful in exerting competitive pricing pressure into the market, drug importation could have a far-reaching impact on patients.
In this report, IPD’s executive clinical pharmacists discuss how drug importation would work under the Final Rule, current and proposed legislation, individual importation, drug importation programs by state, the potential impact of drug importation on the pharmaceutical market, and barriers to drug importation.
Brand Drugs with Expected Generic Competition in Canada in
2H 2022-2024
August 2022
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. For each of these brand-name drugs, (1) data protection appears to have expired (or is close to expiring), and (2) the relevant patent(s) already have expired, are close to expiring, or may be subject to being revoked in court proceedings, or brand companies appear to have reached settlement agreements.
IPD’s Canadian Life-Cycle Insights coverage includes loss-of-exclusivity reports to help our subscribers forecast generic entry and prepare for shifts in the market landscape.
Inflation Reduction Act: An Overview of Drug Price Negotiations and Predicted Lists of Potential Medicare Drugs
June 2023
Drug Price Reform Measures in the 2022 Inflation Reduction Act
August 2022
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.
Although the full impact of the bill is not yet understood, there are several provisions that would potentially impact drug prices. In this report, our team of clinical pharmacists deliver insight into the drug price reform measures in the 2022 Inflation Reduction Act and potential impacts to stakeholders in the market.
Drug Pipeline Report &
Podcast 2H 2022
August 2022
This is the second issue of a bi-annual pipeline report IPD will release in 2022.
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.
This report is used as a companion to our online Clinical Development Tracker, which provides 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.
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.
IPD’s European Life-Cycle Insights coverage includes periodic macro reports to help our subscribers identify read-through from one case to another and to understand larger issues at play.
Patenting of Antibodies in Europe
July 2022
360° Insights: Axsome's AXS-05
July 2022
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.
Axsome’s AXS-05 is a fixed-dose combination of dextromethorphan and bupropion that is currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of major depressive disorder (MDD). Although bupropion is an antidepressant, Axsome has stated that the primary reason for including it in the combination product is to increase the bioavailability of dextromethorphan.
If approved, AXS-05 will be the second FDA-approved NMDA receptor antagonist for the treatment of MDD, after Janssen’s Spravato (esketamine).
The FDA’s Priority Review Voucher (PRV) program was designed to incentivize the creation of medications for unmet needs and underserved disease areas.
With PRVs averaging a sales price of over $100 million and a record high sales price of $350 million, this program offers a substantial incentive for the development of medications for three underserved categories: tropical diseases, rare pediatric diseases, and medical countermeasures. The redemption of a PRV may result in benefits to drug manufacturers that include generating revenue 4 months sooner on a drug and/or earning 4 months of additional revenue prior to generic entry, potentially beating a competitor to the market, and getting a drug approved and on payer formularies by the beginning of the year.
In this paper, we evaluate the benefits of using a PRV through three case studies, assess potential return-on-investment (ROI) calculations, provide a summary of PRVs sold to date, and assess how PRVs may be utilized in the future.
The FDA's Priority Review Voucher Program: Potential Benefits and Risks for Manufacturers and Outlook for Future Use
February 2022
Market Performance Outlook
Recent and Near-Term Drug Approvals to Watch
November 2021
This is the second issue of a recurring series to track the market potential of select products that are likely to impact the market in the coming years.
The report includes both recent and near-term approvals, combining insight from IPD’s expert forecasters with manufacturer earnings reports, presentations, statements, and press releases as well as clinical and regulatory developments.