PERTOFRANE Drug Patent Profile

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

Pertofrane is a drug marketed by Sanofi Aventis Us and is included in one NDA.

The generic ingredient in PERTOFRANE is desipramine hydrochloride. There are nine drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the desipramine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Pertofrane

A generic version of PERTOFRANE was approved as desipramine hydrochloride by ACTAVIS TOTOWA on June 5^th, 1987.

Summary for PERTOFRANE

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	89
Clinical Trials:	3
Patent Applications:	1,610
DailyMed Link:	PERTOFRANE at DailyMed

Recent Clinical Trials for PERTOFRANE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Albert Einstein College of Medicine	N/A
National Cancer Institute (NCI)	N/A
Albert Einstein College of Medicine of Yeshiva University	N/A

See all PERTOFRANE clinical trials

US Patents and Regulatory Information for PERTOFRANE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sanofi Aventis Us	PERTOFRANE	desipramine hydrochloride	CAPSULE;ORAL	013621-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Sanofi Aventis Us	PERTOFRANE	desipramine hydrochloride	CAPSULE;ORAL	013621-002	Approved Prior to Jan 1, 1982		DISCN	No	No

Expired US Patents for PERTOFRANE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi Aventis Us	PERTOFRANE	desipramine hydrochloride	CAPSULE;ORAL	013621-001	Approved Prior to Jan 1, 1982
Sanofi Aventis Us	PERTOFRANE	desipramine hydrochloride	CAPSULE;ORAL	013621-002	Approved Prior to Jan 1, 1982
Sanofi Aventis Us	PERTOFRANE	desipramine hydrochloride	CAPSULE;ORAL	013621-002	Approved Prior to Jan 1, 1982
Sanofi Aventis Us	PERTOFRANE	desipramine hydrochloride	CAPSULE;ORAL	013621-001	Approved Prior to Jan 1, 1982

International Patents for PERTOFRANE

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

Country	Patent Number	Title	Estimated Expiration
Spain	267641
France	1445454	Nouveaux dérivés d'iminodibenzyle et leur préparation

PERTOFRANE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Prescription Drugs: A Case Study on Trends and Implications

Introduction

The pharmaceutical industry is a complex and dynamic sector, influenced by various factors including regulatory changes, technological advancements, and shifting market demands. This article will delve into the market dynamics and financial trajectory of prescription drugs, using recent trends and data to illustrate the broader implications for the industry.

Global Pharmaceutical Market Overview

The global pharmaceutical market is projected to reach $1.15 trillion in 2024 and is expected to exceed $1.4 trillion by 2028. This exponential growth is driven by the increasing global burden of chronic diseases and the rising incidence of conditions such as cancer[3].

Prescription Drug Spending Trends

Between 2016 and 2021, prescription drug spending in the U.S. grew from $520 billion to $603 billion, a 16% increase. This growth was consistent with the overall national healthcare spending, with prescription drugs maintaining approximately an 18% share of total healthcare expenditures[1].

Retail vs. Non-Retail Drug Expenditures

• Retail drug expenditures represented about 70% of prescription drug spending, while non-retail expenditures accounted for around 30%.
• Retail prescription drug spending increased by 13% over the five-year period, primarily driven by a 7% increase in spending per prescription rather than an increase in the number of prescriptions.
• Non-retail drug expenditures saw a more significant increase of 25%, driven by a 19% increase in the number of prescriptions and a 5% increase in spending per prescription[1].

Specialty Drug Spending

Specialty drug spending has been a significant driver of the overall increase in prescription drug expenditures. Between 2016 and 2021, specialty drug spending increased by 43%, reaching $301 billion in 2021. Despite a minimal increase in the number of specialty prescriptions (0.5%), the spending on these drugs rose substantially due to higher costs per prescription[1].

Retail and Non-Retail Specialty Drugs

• In the retail setting, the number of specialty prescriptions dropped in 2020 and 2021, resulting in an 18% decrease in the specialty share of retail prescriptions.
• In contrast, non-retail specialty drug spending increased by 20%, and the number of prescriptions for these drugs rose by 40% over the same period[1].

Investment Trends in Pharmaceutical Research and Development

The development of new drugs is a costly and risky endeavor. The average cost of bringing a new drug to market is approximately $2.6 billion, with a development timeline of 10 to 15 years. The probability of success for a drug candidate entering clinical trials is only about 10%, highlighting the substantial risks involved[3].

Challenges and Opportunities

• Despite the high attrition rate and increasing regulatory hurdles, successful drug development can generate significant revenue streams. For example, AbbVie's monoclonal antibody Humira generated over $20 billion in annual revenue at its peak before losing patent exclusivity in 2023[3].
• The return on investment (ROI) for pharmaceutical R&D has been declining, with Deloitte's analysis showing a forecasted ROI of just 1.2% for the 20 largest pharmaceutical companies in 2022. This decline is attributed to increasing costs and shorter exclusivity periods[3].

Balancing Profit and Public Health

Pharmaceutical companies face the challenge of balancing profit with public health needs. The emergence of new infectious diseases and the growing threat of antimicrobial resistance (AMR) necessitate increased investment in areas that may not offer immediate financial returns.

Addressing Unmet Medical Needs

• The oncology market, for instance, represents a significant opportunity due to the rising incidence of cancer worldwide. By 2040, projections indicate there will be substantial growth in this market[3].
• Initiatives like the AMR Action Fund aim to incentivize investment in developing new antibiotics, despite the financial risks and uncertainties involved[3].

Financial Implications for Pharmaceutical Companies

The financial trajectory of pharmaceutical companies is heavily influenced by the success of their R&D efforts and the market performance of their drugs.

Revenue Streams

• Blockbuster drugs can generate enormous revenue streams, but the loss of patent exclusivity can significantly impact these revenues. For example, Humira's revenue declined after it lost patent exclusivity[3].

Cost Management

• Managing the high costs associated with drug development is crucial. This includes navigating regulatory hurdles, managing clinical trial expenses, and ensuring that the drug can be priced competitively in the market[3].

Key Takeaways

• Prescription drug spending continues to grow, driven by increases in spending per prescription and greater utilization of non-retail drugs.
• Specialty drugs are a significant contributor to this growth, with substantial increases in spending despite minimal changes in the number of prescriptions.
• Pharmaceutical R&D is a high-risk, high-reward endeavor, with declining ROI and increasing costs.
• Balancing profit with public health needs is a critical challenge, particularly in areas like antimicrobial resistance and neglected tropical diseases.

FAQs

What was the total prescription drug spending in the U.S. from 2016 to 2021?

The total prescription drug spending in the U.S. grew from $520 billion in 2016 to $603 billion in 2021, a 16% increase[1].

How has specialty drug spending changed between 2016 and 2021?

Specialty drug spending increased by 43% between 2016 and 2021, reaching $301 billion in 2021, despite only a 0.5% increase in the number of specialty prescriptions[1].

What are the challenges in developing new drugs?

Developing new drugs is costly, with an average cost of $2.6 billion and a development timeline of 10 to 15 years. The probability of success for a drug candidate entering clinical trials is only about 10%[3].

How does the ROI for pharmaceutical R&D impact the industry?

The ROI for pharmaceutical R&D has been declining, with a forecasted ROI of just 1.2% for the 20 largest pharmaceutical companies in 2022. This decline is due to increasing costs and shorter exclusivity periods[3].

What initiatives are in place to address antimicrobial resistance?

Initiatives like the AMR Action Fund aim to incentivize investment in developing new antibiotics, addressing the financial risks and uncertainties involved in this area[3].

Sources

1. Trends in Prescription Drug Spending, 2016-2021 - ASPE
2. Managing target date strategies through all market cycles - J.P. Morgan
3. Investment Trends in Pharmaceutical Research - DrugBank Blog
4. Pharmaceutical Trends Overview Report - PMPRB-CEPMB
5. How dynamic credit can mitigate downside risk - T. Rowe Price