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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.

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.

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.

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 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.

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.

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.”

The NCE-1 date is often the first opportunity for a generic drug manufacturer to submit an ANDA referencing a branded drug with NCE exclusivity and is therefore critical for pursuing 180-day marketing exclusivity granted to a first-filed ANDA.

Whether to pursue an ANDA submission at an NCE-1 date is a complex decision for a generic drug manufacturer. Thus, examining trends in ANDA submissions at the NCE-1 date can provide useful insights into the changing dynamics in the generic drug landscape.

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.

More recently, however, brand manufacturers are increasingly using AGs to compete with other brands as well. Shifts in contracting and rebate dynamics have made AGs a cornerstone of a “dual strategy” by which manufacturers attempt to capture and retain market share.

This new trend creates the need for complementary strategies on the part of payers and PBMs to preemptively manage AGs. Likewise, manufacturers should fully understand the factors impacting payer management of AGs in order to maximize their success.

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. Check out this brief to learn about loss-of-exclusivity-analysis.

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.

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.

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.

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.

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.

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 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.

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.

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.”

The NCE-1 date is often the first opportunity for a generic drug manufacturer to submit an ANDA referencing a branded drug with NCE exclusivity and is therefore critical for pursuing 180-day marketing exclusivity granted to a first-filed ANDA.

Whether to pursue an ANDA submission at an NCE-1 date is a complex decision for a generic drug manufacturer. Thus, IPD examines trends in ANDA submissions at the NCE-1 date to provide useful insights into the changing dynamics in the generic drug landscape.

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.

Stakeholders can no longer rely on assumptions that have been considered standard for predicting pricing and erosion after a generic launch. Instead, identifying noteworthy market conditions and understanding the outcomes they trigger provides more accurate insight for stakeholders who are forecasting the market and financial impact of a generic launch.

IPD Analytics has identified four market factors as representative elements that can cause deviations from traditionally standard generic launch patterns, including: copay coupons, brand-over-generic strategies, supply channel strategies, and shifts in manufacturer pricing strategies.

This insight brief describes key elements of an expanded model versus a traditional model of a generic launch that are essential to understanding the shifting generic landscape.