PROSOM Drug Patent Profile

Which patents cover Prosom, and when can generic versions of Prosom launch?

Prosom is a drug marketed by Abbott and is included in one NDA.

The generic ingredient in PROSOM is estazolam. There are three drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the estazolam profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Prosom

A generic version of PROSOM was approved as estazolam by NOVITIUM PHARMA on July 3^rd, 1997.

Summary for PROSOM

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	51
Patent Applications:	3,999
DailyMed Link:	PROSOM at DailyMed

US Patents and Regulatory Information for PROSOM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbott	PROSOM	estazolam	TABLET;ORAL	019080-001	Dec 26, 1990		DISCN	Yes	No
Abbott	PROSOM	estazolam	TABLET;ORAL	019080-002	Dec 26, 1990		DISCN	Yes	No

Expired US Patents for PROSOM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbott	PROSOM	estazolam	TABLET;ORAL	019080-001	Dec 26, 1990	3,987,052
Abbott	PROSOM	estazolam	TABLET;ORAL	019080-002	Dec 26, 1990	3,987,052

International Patents for PROSOM

See the table below for patents covering PROSOM around the world.

Country	Patent Number	Title	Estimated Expiration
Denmark	449378
Belgium	779988
Germany	2065893
France	2034999
Netherlands	172510

PROSOM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Prescription Drugs: A Case Study on Stimulants and Other Controlled Substances

Introduction

The pharmaceutical market is a complex and dynamic sector, influenced by a myriad of factors including regulatory changes, patient demographics, prescriber behaviors, and economic pressures. This article will delve into the market dynamics and financial trajectory of prescription drugs, with a specific focus on stimulants, using data and trends from recent reports and studies.

Market Trends in Stimulant Prescriptions

Overall Trends

From 2012 to 2022, the number of stimulant prescriptions dispensed in the US increased significantly. According to the IQVIA Report, there was a 57.9% increase in the overall dispensing of stimulants, rising from 50.4 million prescriptions in 2012 to 79.6 million in 2022[1].

Patient Demographics

The demographics of patients receiving stimulant prescriptions have also shifted. There was a notable increase in prescriptions dispensed to women and older adults. For females, the number of prescriptions increased by 87.5% from 2012 to 2022, while for males, it increased by 35.3% during the same period. The 31-40 year-old age group saw prescriptions more than triple since 2012, and the share of prescriptions for this group increased from 10.1% to 22.0% of all stimulant prescriptions[1].

Impact of COVID-19

The COVID-19 pandemic had a significant impact on stimulant prescriptions. There was a steep decline in the number of prescriptions dispensed immediately after the pandemic restrictions were implemented, but by October 2020, the dispensing had rebounded to pre-pandemic levels. The use of telemedicine for stimulant prescriptions also saw a surge, increasing from less than 1% in March 2020 to 10% in April 2020, though it later declined to 5.4% by the end of 2022[1].

Co-Prescription Trends

Co-Prescription with Other Controlled Substances

The co-prescription of stimulants with other controlled substances, such as opioids, has been a concern. However, the proportion of stimulant prescriptions with a co-prescription of an opioid medication decreased from 17% in 2012 to 7% in 2022[1].

Financial Implications and Revenue Streams

Impact of Medicare Drug Price Negotiation Program

The Medicare Drug Price Negotiation Program, part of the Inflation Reduction Act (IRA), has significant financial implications for drug manufacturers. For small molecule drugs, which include many stimulants, the program reduces net sales through set discounts ranging from 38-79% and additional pressure from plan sponsors to discount further using rebates. This can drive volume away from selected drugs, impacting their gross sales[3].

Sales Trajectories and Revenue

Drug sales trajectories vary significantly, with some drugs experiencing higher sales in the later years after launch. For small molecule drugs, years 10-13 after launch account for a substantial portion of total sales, making the Medicare Drug Price Negotiation Program particularly impactful. Novel, first-in-class therapies are especially affected, with 40% of gross and 38% of net total sales occurring between 10 to 13 years after launch[3].

Formulary Management and High-Cost Therapies

Strategic Directions in Formulary Management

The management of high-cost and complex therapies is becoming increasingly critical. Health-system pharmacy leaders need to consider financial risks, resource allocation, and the sustainability of offering these therapies. This includes collaborating with finance and revenue cycle teams to assess the impact on revenue and incorporating these factors into formulary decisions[2].

Distribution Channels and Business Models

New distribution channels and business models are disrupting traditional practices. Pharmacy benefit managers (PBMs) are shifting from rebate-driven profits to administrative and service fees, and health systems are considering direct contracting with manufacturers to manage high-cost drugs more effectively[2].

Challenges and Opportunities

Mitigating Misuse and Abuse

The increased availability of stimulants due to higher prescribing rates has raised concerns about misuse and abuse. Understanding who is prescribing these medications, in what setting, and to which patients can help inform strategies to mitigate these issues[1].

Adapting to Regulatory Changes

Biopharmaceutical companies must adapt to regulatory changes, such as the Medicare Drug Price Negotiation Program, which affects their revenue and investment decisions. This program creates uncertainty and disincentives for long-term investments in drug development, particularly for small molecule drugs[3].

Key Takeaways

• Increased Prescribing Trends: Stimulant prescriptions have seen a significant increase, especially among women and older adults.
• COVID-19 Impact: The pandemic led to a temporary decline but subsequent rebound in stimulant prescriptions, with an increase in telemedicine use.
• Financial Implications: Regulatory changes like the Medicare Drug Price Negotiation Program significantly impact drug sales and revenue, particularly for small molecule drugs.
• Formulary Management: Health systems must carefully manage high-cost therapies, considering financial and operational implications.
• Adaptation to Changes: Biopharmaceutical companies need to adapt to new regulatory and market dynamics to remain viable.

FAQs

What has been the trend in stimulant prescriptions from 2012 to 2022?

The number of stimulant prescriptions dispensed in the US increased by 57.9% from 2012 to 2022, with significant increases among women and older adults[1].

How has the COVID-19 pandemic affected stimulant prescriptions?

The pandemic led to a temporary decline in stimulant prescriptions but saw a rebound by October 2020. Telemedicine use for these prescriptions also increased during this period[1].

What is the impact of the Medicare Drug Price Negotiation Program on drug manufacturers?

The program reduces net sales through set discounts and additional rebates, affecting the revenue and investment decisions of drug manufacturers, especially for small molecule drugs[3].

How are health systems managing high-cost therapies?

Health systems are collaborating with finance and revenue cycle teams to assess the financial and operational implications of offering high-cost therapies and are considering new distribution channels and business models[2].

What challenges do biopharmaceutical companies face due to regulatory changes?

Biopharmaceutical companies face uncertainty and disincentives for long-term investments in drug development due to regulatory changes like the Medicare Drug Price Negotiation Program[3].

Sources

1. IQVIA Report on Stimulant Trends from 2012 - 2022. U.S. Department of Justice, Drug Enforcement Administration.
2. Strategic Directions in System Formulary, Drug Policy, and High-Cost Drugs. American Society of Health-System Pharmacists.
3. Medicare's Drug Price Negotiation Program. IQVIA.