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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...

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...

Patenting of Antibodies in Europe

July 2022

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...

Biosimilar Pipeline Report: Mid 2022

May 2022

In this report, IPD Analytics provides an outlook for potential approvals and launches across the biosimilar landscape over the 2022–2025 horizon...

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...

Recent Trends in ANDA Submissions One Year Prior to NCE Exclusivity Expirations

September 2021

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.”

There’s Nothing Generic About a Generic Launch: How Shifting Market Dynamics and Stakeholder Strategies Are Disrupting Standard Assumptions for Forecasting the Impact of Generic Entrants

November 2019

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...

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.

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.

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...

Drug Pipeline Report &
Podcast 2H 2022

August 2022

In this report, IPD Analytics provides detailed summaries of key drugs nearing potential FDA approval in the coming months...​

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...

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...

The FDA's Priority Review Voucher Program: Potential Benefits and Risks for Manufacturers and Outlook for Future Use

February 2022

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

Understanding Recent Trends in ANDA Submissions One Year Prior to Expiration of NCE Exclusivity (NCE-1)

December 2021

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.”

Authorized to Compete: Shifting Competitive Strategies Require a Fresh Look at Authorized Generics

February 2020

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...

Losing by Winning at the Patent Office: Zytiga Case Illustrates How IPR Estoppel Could Reshape Patent Challenges and Delay Generic Launches

June 2019

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.

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