CERETEC Drug Patent Profile

When do Ceretec patents expire, and when can generic versions of Ceretec launch?

Ceretec is a drug marketed by Ge Healthcare and is included in one NDA.

The generic ingredient in CERETEC is technetium tc-99m exametazime kit. There are four drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the technetium tc-99m exametazime kit profile page.

Summary for CERETEC

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	4
Clinical Trials:	2
Patent Applications:	41
Drug Prices:	Drug price information for CERETEC
What excipients (inactive ingredients) are in CERETEC?	CERETEC excipients list
DailyMed Link:	CERETEC at DailyMed

See drug prices for CERETEC

Recent Clinical Trials for CERETEC

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

Sponsor	Phase
Norton Healthcare	Phase 2
University of Kentucky	Phase 2
Thomas Hatschek	Phase 2

See all CERETEC clinical trials

Pharmacology for CERETEC

Drug Class	Radioactive Diagnostic Agent
Mechanism of Action	Radiopharmaceutical Activity

US Patents and Regulatory Information for CERETEC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ge Healthcare	CERETEC	technetium tc-99m exametazime kit	INJECTABLE;INJECTION	019829-001	Dec 30, 1988		RX	Yes	Yes

Expired US Patents for CERETEC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ge Healthcare	CERETEC	technetium tc-99m exametazime kit	INJECTABLE;INJECTION	019829-001	Dec 30, 1988	4,615,876
Ge Healthcare	CERETEC	technetium tc-99m exametazime kit	INJECTABLE;INJECTION	019829-001	Dec 30, 1988	4,789,736

International Patents for CERETEC

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

Country	Patent Number	Title	Estimated Expiration
Germany	123504
Japan	H0211593
Spain	531865
Australia	564636

Supplementary Protection Certificates for CERETEC

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

CERETEC Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: CERETEC

Introduction

Ceretec, also known as Technetium Tc99m Exametazime Injection, is a diagnostic imaging agent used in various medical procedures, including the detection of altered regional cerebral perfusion in stroke and the localization of intraabdominal infections. To understand the market dynamics and financial trajectory of Ceretec, it is essential to delve into several key factors, including market competition, pricing mechanisms, regulatory environments, and industry trends.

Market Competition and Therapeutic Class

Ceretec belongs to the therapeutic class of diagnostic imaging agents, specifically those using technetium-99m. This class is relatively niche, with a limited number of competitors. However, the lack of therapeutically equivalent drugs can sometimes lead to market dominance by a single or a few companies, which can influence pricing and availability[4].

Pricing Mechanisms

The pricing of Ceretec, like other prescription drugs, is influenced by several factors including research and development costs, market exclusivity, and the presence of generic or therapeutically equivalent alternatives. In the pharmaceutical market, the usual mechanisms of market discipline may not apply in the same way as in other industries. Health care providers often make purchasing decisions on behalf of patients, who may be unaware of the drug costs due to third-party payers[1][4].

Patent Protection and Market Exclusivity

Patent protection and market exclusivity play significant roles in the pricing and availability of drugs like Ceretec. These protections allow drug companies to recoup their research and development costs and earn a return on their investment. For Ceretec, any patent or exclusivity period would limit competition, potentially leading to higher prices and greater market control for the manufacturer[1][4].

Corporate Consolidations and Market Domination

The pharmaceutical industry has seen an increase in corporate consolidations through mergers and acquisitions. This trend can lead to fewer companies producing and marketing drugs, resulting in greater market domination and less competition. If the rights to Ceretec were transferred to a new company, especially one with significant market power, it could lead to extraordinary price increases, as observed in other cases[1][4].

Extraordinary Price Increases

Ceretec, being a brand-name drug, could be subject to extraordinary price increases if it falls into the categories where such increases are common. According to the GAO report, extraordinary price increases are more common in therapeutic classes such as central nervous system agents, anti-infective agents, and cardiovascular agents, although Ceretec does not fall directly into these categories. However, if it is part of a niche market with limited competition, it could still experience significant price hikes[4].

Regulatory Environment

The regulatory environment, particularly the FDA's approval process and designations such as Orphan Drug or Breakthrough Therapy, can significantly impact the market trajectory of a drug. While Ceretec does not have these specific designations, any changes in regulatory policies or approvals can affect its market position and pricing[2].

Usage and Demand

Ceretec is used in specific medical procedures, such as detecting altered regional cerebral perfusion in stroke and localizing intraabdominal infections. The demand for Ceretec is tied to the prevalence of these conditions and the adoption of technetium-99m based diagnostic techniques. Any changes in medical practices or the introduction of alternative diagnostic methods could impact its demand and, consequently, its financial trajectory[5].

Financial Impact of Market Dynamics

The financial trajectory of Ceretec is heavily influenced by the market dynamics outlined above. Here are some key points:

• Revenue Stream: The revenue generated by Ceretec would be influenced by its pricing, which in turn is affected by patent protection, market exclusivity, and competition.
• Cost Structure: The cost structure includes research and development expenses, manufacturing costs, and marketing expenditures. These costs are typically high for diagnostic imaging agents.
• Market Share: The market share of Ceretec would depend on its competitive position within the diagnostic imaging market. A lack of competition could lead to a higher market share but also higher prices.
• Growth Potential: The growth potential of Ceretec is tied to the growth in the demand for diagnostic imaging procedures and the absence of strong competitors.

Case Studies and Industry Trends

Studies on brand-name prescription drug pricing highlight that extraordinary price increases are not uncommon, especially in therapeutic classes with limited competition. For example, the GAO report notes that between 2000 and 2008, the number of extraordinary price increases more than doubled, with most increases ranging between 100% and 499%[4].

Expert Insights

Industry experts and representatives often point out that the pace of consolidation among drug companies and the transfer of drug ownership rights can lead to fewer drug options and contribute to extraordinary price increases. This trend suggests that the financial trajectory of Ceretec could be influenced by broader industry dynamics rather than just its specific market position[1][4].

Key Takeaways

• Market Competition: Ceretec operates in a niche market with limited competition, which can lead to higher prices and greater market control.
• Pricing Mechanisms: Pricing is influenced by patent protection, market exclusivity, and the absence of therapeutically equivalent alternatives.
• Regulatory Environment: Regulatory policies and approvals can significantly impact the market position and pricing of Ceretec.
• Demand and Usage: Demand is tied to the prevalence of specific medical conditions and the adoption of technetium-99m based diagnostic techniques.
• Financial Trajectory: The financial trajectory is influenced by revenue streams, cost structures, market share, and growth potential.

FAQs

What are the primary factors influencing the pricing of Ceretec?

The primary factors include patent protection, market exclusivity, the absence of therapeutically equivalent alternatives, and the regulatory environment.

How does corporate consolidation affect the market for Ceretec?

Corporate consolidation can lead to fewer companies producing and marketing drugs, resulting in greater market domination and less competition, which can drive up prices.

What is the impact of the regulatory environment on Ceretec?

The regulatory environment, including FDA approvals and designations, can affect the market position and pricing of Ceretec by influencing its availability and competition.

How does the demand for Ceretec relate to its financial trajectory?

The demand for Ceretec, tied to the prevalence of specific medical conditions and the adoption of technetium-99m based diagnostic techniques, directly impacts its revenue and growth potential.

Can extraordinary price increases occur for Ceretec?

Yes, extraordinary price increases can occur for Ceretec, especially if it operates in a niche market with limited competition and is subject to patent protection and market exclusivity.

Sources

1. GAO-10-201 Brand-Name Prescription Drug Pricing - U.S. Government Accountability Office.
2. Travere Therapeutics, Inc. Press Release - Travere Therapeutics, Inc.
3. The economics of follow-on drug research and development - PubMed.
4. GAO-10-201, Brand-Name Prescription Drug Pricing - U.S. Government Accountability Office.
5. Ceretec (Technetium Tc99m Exametazime Injection) - RxList.