ACUTECT Drug Patent Profile

Which patents cover Acutect, and what generic alternatives are available?

Acutect is a drug marketed by Cis Bio Intl Sa and is included in one NDA.

The generic ingredient in ACUTECT is technetium tc-99m apcitide. There are four drug master file entries for this compound. Additional details are available on the technetium tc-99m apcitide profile page.

Summary for ACUTECT

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	2
DailyMed Link:	ACUTECT at DailyMed

US Patents and Regulatory Information for ACUTECT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cis Bio Intl Sa	ACUTECT	technetium tc-99m apcitide	INJECTABLE;INJECTION	020887-001	Sep 14, 1998		DISCN	No	No

Expired US Patents for ACUTECT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cis Bio Intl Sa	ACUTECT	technetium tc-99m apcitide	INJECTABLE;INJECTION	020887-001	Sep 14, 1998
Cis Bio Intl Sa	ACUTECT	technetium tc-99m apcitide	INJECTABLE;INJECTION	020887-001	Sep 14, 1998
Cis Bio Intl Sa	ACUTECT	technetium tc-99m apcitide	INJECTABLE;INJECTION	020887-001	Sep 14, 1998

International Patents for ACUTECT

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

Country	Patent Number	Title	Estimated Expiration
Australia	5402694
European Patent Office	1092726	Peptides dérivés de la somatostatine et marqués de manière radioactive pour imagerie et utilisations thérapeutiques (Radioactively-labeled somatostatin derived peptides for imaging and therapeutics uses)
World Intellectual Property Organization (WIPO)	9323085
South Africa	9404498
Japan	H08502261
World Intellectual Property Organization (WIPO)	9423758

Supplementary Protection Certificates for ACUTECT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1178838	300736	Netherlands		PRODUCT NAME: TILMANOCEPT, DESGEWENST GELABELD MET TECHNETIUM TC 99M; REGISTRATION NO/DATE: EU/1/14/955 20141119

ACUTECT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Pharmaceutical Industry: Insights Relevant to Drugs Like ACUTECT

Introduction to the Pharmaceutical Market

The pharmaceutical industry is undergoing significant transformations driven by technological advancements, changing regulatory landscapes, and evolving market demands. To understand the market dynamics and financial trajectory of a drug like ACUTECT, it is essential to delve into the broader trends and challenges facing the pharmaceutical sector.

Global Pharmaceutical Market Overview

The global pharmaceutical market is projected to reach substantial heights, with the U.S. market alone expected to grow from USD 602.19 billion in 2023 to USD 1,093.79 billion by 2033, at a CAGR of 6.15% from 2024 to 2033[1].

Key Market Segments and Growth Drivers

By Molecule Type

The market is dominated by conventional drugs (small molecules), which held a revenue share of 56.21% in 2023. However, the biologics and biosimilars segment is expected to witness the fastest growth over the forecast period[1].

By Disease

The cancer segment dominated the market with a share of 16.79% in 2023, while the neurological disorders segment is anticipated to grow at the fastest CAGR from 2024 to 2033[1].

By Route of Administration

Oral routes dominated the market with a 59.9% revenue share in 2023, but the parenteral route is expected to expand at the fastest CAGR over the forecast period[1].

Financial Challenges in Drug Development

Developing a new drug 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 spanning 10 to 15 years. The probability of success for a drug candidate entering clinical trials is only around 10%[5].

Case Study: Achaogen and Plazomicin

The story of Achaogen and its antibiotic plazomicin highlights the financial struggles faced by pharmaceutical companies. Despite raising close to $800 million, Achaogen's sales were dismal, leading to bankruptcy and the eventual sale of the company for a fraction of its investment. The post-approval costs, including manufacturing, pharmacovigilance, and pediatric development, were estimated to be around $350 million for the first 10 years after approval, which could not be covered by the small revenues generated by an antibiotic reserved for a small patient population[2].

Return on Investment (ROI) and Sustainability

The ROI for pharmaceutical R&D has been declining, raising concerns about the sustainability of the current R&D model. Deloitte's analysis revealed a forecasted ROI of just 1.2% for the 20 largest pharmaceutical companies in 2022, down from 1.9% in 2021. This decline is attributed to increasing regulatory hurdles and shorter exclusivity periods due to patent challenges and the introduction of generic or biosimilar competitors[5].

Market Trends and Opportunities

Precision Medicines

The shift towards precision medicines has significant economic implications. These drugs, targeting small patient populations, can generate high prices and profits but also face limited generic competition, which can extend the period of little or no competition for the original brand-name drug[3].

Oncology and Chronic Diseases

The oncology market represents a vast opportunity due to the rising incidence of cancer worldwide. Similarly, the escalating global burden of chronic diseases is driving the growth of the pharmaceutical market, with companies strategically aligning their R&D investments to address these unmet medical needs[5].

Regulatory and Policy Impacts

FDA Approvals and Regulatory Changes

The FDA's approval process and regulatory changes significantly impact the pharmaceutical market. For instance, the FDA's proposed rule on "Nonprescription Drug Product with an Additional Condition for Nonprescription Use" aims to increase the development and marketing options for safe and effective nonprescription drug products, which could enhance public health by broadening the range of nonprescription drugs available to consumers[1].

Financial Trajectory for a Drug Like ACUTECT

Given the broader market dynamics, here are some key points to consider for the financial trajectory of a drug like ACUTECT:

Development Costs

The development of ACUTECT, like any other drug, would involve substantial costs, likely in the range of $2.6 billion, and a long development timeline[5].

Market Positioning

ACUTECT would need to be positioned within a specific market segment, such as the cancer or neurological disorders segment, to capitalize on growth opportunities. The route of administration and the target patient population would also play crucial roles in determining its market share[1].

Revenue Projections

The revenue projections for ACUTECT would depend on its market positioning, competition, and the ability to secure FDA approval and maintain market exclusivity. The drug's pricing strategy would need to balance profitability with public health considerations, especially if it targets a small patient population[3].

Post-Approval Costs

After approval, ACUTECT would face significant post-approval costs, including manufacturing, pharmacovigilance, and pediatric development. These costs, estimated to be around $350 million for the first 10 years, would need to be factored into the drug's financial planning[2].

Key Takeaways

• The pharmaceutical market is driven by a robust pipeline of specialty drugs and increasing brand name pharmaceutical manufacturers.
• The development and commercialization of drugs are highly costly and risky.
• Precision medicines and drugs targeting small patient populations face unique financial and regulatory challenges.
• Regulatory changes and FDA approvals significantly impact market dynamics.
• Post-approval costs are substantial and must be carefully managed.

FAQs

Q: What is the projected growth rate of the U.S. pharmaceutical market? A: The U.S. pharmaceutical market is expected to grow at a CAGR of 6.15% from 2024 to 2033[1].

Q: What are the primary challenges in developing new drugs? A: The primary challenges include high development costs (around $2.6 billion), long development timelines (10-15 years), and low success rates (around 10%)[5].

Q: How do precision medicines impact the pharmaceutical market? A: Precision medicines can generate high prices and profits but face limited generic competition, extending the period of little or no competition for the original brand-name drug[3].

Q: What role do regulatory changes play in the pharmaceutical market? A: Regulatory changes, such as FDA approvals and proposed rules, significantly impact market dynamics by influencing the development, marketing, and accessibility of drugs[1].

Q: What are the post-approval costs for a new drug? A: Post-approval costs include manufacturing, pharmacovigilance, and pediatric development, estimated to be around $350 million for the first 10 years after approval[2].

Cited Sources

1. U.S. Pharmaceutical Market Size to Reach USD 1,093.79 Billion By 2033 - Biospace
2. Plazomicin (Achaogen) financial post-mortem: #PassPASTEUR - AMR Solutions
3. The Economics of Drug Development: Pricing and Innovation in a Changing Market - NBER
4. Global Market for Pain Management Drugs and Devices - BCC Research
5. Investment Trends in Pharmaceutical Research - DrugBank Blog