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Last Updated: January 3, 2025

PRE-SATE Drug Patent Profile


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Which patents cover Pre-sate, and when can generic versions of Pre-sate launch?

Pre-sate is a drug marketed by Parke Davis and is included in one NDA.

The generic ingredient in PRE-SATE is chlorphentermine hydrochloride. There is one drug master file entry for this compound. Additional details are available on the chlorphentermine hydrochloride profile page.

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Summary for PRE-SATE
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 40
Patent Applications: 54
DailyMed Link:PRE-SATE at DailyMed
Drug patent expirations by year for PRE-SATE

US Patents and Regulatory Information for PRE-SATE

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Parke Davis PRE-SATE chlorphentermine hydrochloride TABLET;ORAL 014696-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 1 of 1 entries

PRE-SATE Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Prescription Drugs: Key Trends and Insights

Introduction

The pharmaceutical industry is undergoing significant transformations driven by regulatory changes, market dynamics, and technological advancements. Here, we delve into the current trends and financial trajectories that are shaping the prescription drug market.

Global Market Growth

Compound Annual Growth Rate (CAGR)

Prescription drug sales globally are anticipated to grow at a CAGR of 5.9% from 2022 to 2028, reaching a value of nearly $1.6 trillion. This growth is driven by advances in areas such as cancer, neurology, and obesity treatments[2].

Market Access Trends

Pharmacy Biosimilar Adoption

Biosimilar adoption is a critical trend in 2024. Despite the entry of 12 biosimilars for adalimumab, their combined market share remained around 1% at the end of 2023. However, with the potential lowering of rebate walls by pharmacy benefit managers (PBMs), there is an expectation of rapid conversion to formulary-preferred interchangeable biosimilars, especially within vertically integrated systems[1].

Modern Launch Challenges

The launch of new prescription drugs faces significant challenges, including lagging payer coverage, physician adoption, and patient activation. Average first-year revenues for launch products reimbursed under the pharmacy benefit have dropped from $140 million in 2018 to $60 million in 2022. Manufacturers are increasingly using transition assistance programs to subsidize patient demand and smooth the prescriber experience[1].

Evidence-Based Decision Making

Stronger evidence throughout the product lifecycle is crucial for substantiating pricing decisions, countering third-party assessments, and speeding up payer adoption. Early pre-launch investment in evidence generation is vital, as it can take years to build the necessary longitudinal evidence for success in modern markets[1].

Pricing Dynamics

Pricing Pressure and Plateaus

Pricing practices in the industry are stabilizing, with annual net price increases for drugs at or below the rate of inflation since 2017. The combination of price controls may pressure manufacturers to launch products at higher list prices to account for the inevitable net price decline over the product's lifecycle[1].

Generic Drug Pricing

Generic drug prices decline significantly as the number of competitors increases. Prices for the initial generic monopolist are 35% to 50% above long-run marginal costs but approach these costs when there are eight or more competitors[3].

Regulatory and Legislative Impact

Inflation Reduction Act (IRA)

The passage of the IRA in the US, which includes the Medicare Drug Price Negotiation Program and Medicare Part D prescription drug plan reforms, has influenced forecasted valuations. This legislation is expected to impact the financial trajectory of prescription drugs by controlling prices and altering market dynamics[2].

PDUFA VII Financial Plan

The Prescription Drug User Fee Act (PDUFA) VII five-year financial plan outlines the anticipated financial position of the program. The plan includes estimates for target revenue, net collections, and total budgetary resources, highlighting the financial commitments and expectations for the FDA in regulating prescription drugs[5].

Patient Access and Alternative Channels

Cracks in the System

Post-pandemic access to care, market economics, and skinnier drug formularies are pressuring patients and drug utilization. There has been a significant increase in the use of cash pay options, drug discount cards like GoodRx, and telehealth services. Over 8.5% of the total U.S. drug universe now moves through the cash channel, up from a pre-pandemic 5%[1].

340B Program Challenges

The 340B pharmacy network continues to face challenges, despite efforts by manufacturers to limit its growth. Channel growth has pushed total sales to over $100 million, impacting the supply chain, manufacturer net prices, and insurance premiums[1].

Financial Trajectory

Global Sales Projections

The top 10 global Rx sales producers by 2028 are expected to include companies like Roche, Merck & Co., AbbVie, and Pfizer, among others. These companies are projected to bring in more than $160 billion combined, driven by advances in key therapeutic areas[2].

Revenue Impact of COVID-19

The COVID-19 pandemic resulted in a significant spike in healthcare spending, particularly in the U.S. However, sales of SARS-CoV-2-related products have declined from over $100 billion in 2022 to an expected $30 billion by 2028[2].

Key Takeaways

  • Global Growth: Prescription drug sales are projected to grow at a CAGR of 5.9% from 2022 to 2028.
  • Biosimilar Adoption: Biosimilars face challenges but may see rapid adoption with changes in rebate walls.
  • Pricing Dynamics: Pricing practices are stabilizing, with net price increases at or below inflation rates.
  • Regulatory Impact: The IRA and PDUFA VII financial plan are significant regulatory factors.
  • Patient Access: Alternative channels like cash pay options and telehealth are gaining traction.
  • Financial Projections: Top pharmaceutical companies are expected to generate substantial revenues by 2028.

FAQs

What is the projected global CAGR for prescription drug sales from 2022 to 2028?

The global CAGR for prescription drug sales is anticipated to be 5.9% from 2022 to 2028[2].

How are biosimilars impacting the market in 2024?

Biosimilars are expected to see rapid adoption, especially within vertically integrated systems, as rebate walls are potentially lowered by PBMs[1].

What are the challenges faced by new drug launches in the current market?

New drug launches face challenges such as lagging payer coverage, physician adoption, and patient activation, leading to lower first-year revenues compared to historical trends[1].

How does the Inflation Reduction Act (IRA) impact the pharmaceutical industry?

The IRA, through its Medicare Drug Price Negotiation Program and Medicare Part D reforms, influences forecasted valuations and pricing dynamics in the industry[2].

What alternative channels are patients using for prescription drugs?

Patients are increasingly using cash pay options, drug discount cards like GoodRx, and telehealth services due to favorable pricing and restricted access through traditional models[1].

How does the 340B program affect the pharmaceutical industry?

The 340B program continues to impact the supply chain, manufacturer net prices, and insurance premiums, despite efforts by manufacturers to limit its growth[1].

Sources

  1. IQVIA: Top 10 U.S. Market Access Trends for 2024
  2. Pharmaceutical Commerce: The Path for Prescription Drug Sales
  3. Federal Trade Commission: Generic Drug Industry Dynamics
  4. Global Initiative: Global Synthetic Drug Markets: The Present and Future
  5. FDA: PDUFA VII Five-Year Financial Plan - 2024

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