TECZEM Drug Patent Profile

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

Teczem is a drug marketed by Biovail and is included in one NDA.

The generic ingredient in TECZEM is diltiazem malate; enalapril maleate. There are twenty-six drug master file entries for this compound. Additional details are available on the diltiazem malate; enalapril maleate profile page.

Summary for TECZEM

US Patents:	0
Applicants:	1
NDAs:	1
DailyMed Link:	TECZEM at DailyMed

US Patents and Regulatory Information for TECZEM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Biovail	TECZEM	diltiazem malate; enalapril maleate	TABLET, EXTENDED RELEASE;ORAL	020507-001	Oct 4, 1996		DISCN	No	No

Expired US Patents for TECZEM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Biovail	TECZEM	diltiazem malate; enalapril maleate	TABLET, EXTENDED RELEASE;ORAL	020507-001	Oct 4, 1996
Biovail	TECZEM	diltiazem malate; enalapril maleate	TABLET, EXTENDED RELEASE;ORAL	020507-001	Oct 4, 1996
Biovail	TECZEM	diltiazem malate; enalapril maleate	TABLET, EXTENDED RELEASE;ORAL	020507-001	Oct 4, 1996
Biovail	TECZEM	diltiazem malate; enalapril maleate	TABLET, EXTENDED RELEASE;ORAL	020507-001	Oct 4, 1996

International Patents for TECZEM

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	0309051	CONTROLLED POROSITY OSMOTIC PUMP
Canada	1275349	DERIVES D'ACIDE AMINIQUE (AMINO ACID DERIVATIVES)
Japan	H0563210
South Africa	8708675

TECZEM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Prescription Drugs: A Case Study on Generic Entry and Market Forces

Introduction

The pharmaceutical industry is a complex and highly regulated market, influenced by a myriad of factors including regulatory frameworks, market competition, and financial pressures. This article will delve into the market dynamics and financial trajectory of prescription drugs, using the context of generic drug entry as a case study, and will touch on the specific example of drugs like TECZEM (a combination of telmisartan and amlodipine) to illustrate key points.

Regulatory Frameworks and Generic Entry

The Hatch-Waxman Act

The Hatch-Waxman Act, enacted over 30 years ago, has been instrumental in facilitating the entry of generic drugs into the U.S. market. This act provides a regulatory and judicial framework that expedites generic drug entry by lowering patent-related barriers, thereby increasing competition and reducing drug prices[1].

Biologics Price Competition and Innovation Act

For biologic drugs, the Biologics Price Competition and Innovation Act (BPCIA) of 2010 offers a similar framework, aiming to encourage the development of biosimilars and reduce costs associated with these complex biological products[1].

Factors Influencing Generic Entry

Price and Non-Price Factors

Generic drug manufacturers face various price and non-price factors that influence their decision to enter a market. These include the remaining patent life of the branded drug, market size, and the presence of other generic competitors. Non-price factors can include regulatory hurdles, the complexity of the drug formulation, and the need for significant investment in research and development[1].

Role of Intermediaries

Intermediaries such as pharmacy benefit managers (PBMs) and group purchasing organizations (GPOs) play a crucial role in the pharmaceutical supply chain. They can affect drug prices through contractual relationships with manufacturers and health plan sponsors. These intermediaries can either facilitate or hinder generic entry by influencing the reimbursement rates and formulary listings[1].

Financial Trajectory of Prescription Drugs

Market Growth and Drivers

The global pharmaceutical drug delivery market is projected to grow from USD 1,949.4 billion in 2024 to USD 2,546.0 billion by 2029, driven by factors such as the increasing prevalence of chronic diseases, technological advancements in drug delivery systems, and the growing geriatric population[3].

Revenue Pressures

Pharmaceutical companies face significant revenue pressures due to government and insurer demands for lower drug prices. This pressure is particularly acute for generic drugs, where price competition is fierce. The adoption of price caps and the bargaining power of PBMs and insurers further reduce the revenue potential for pharmaceutical companies[3].

Case Study: TECZEM

Market Dynamics

TECZEM, a combination of telmisartan and amlodipine, is used to treat hypertension. The market dynamics for such a drug are influenced by the presence of branded and generic versions. When the patent for the branded version expires, generic manufacturers can enter the market, significantly reducing prices and increasing competition.

Generic Entry and Competition

The entry of generic versions of TECZEM would be influenced by the factors mentioned earlier, including the regulatory framework, market size, and the role of intermediaries. Generic manufacturers would need to navigate these factors to ensure successful market entry and to compete effectively with other generic and branded products.

Financial Impact

The financial impact of generic entry for TECZEM would be substantial. Generic versions would likely reduce the market share and revenue of the branded product, leading to lower prices for consumers. However, this also means reduced profit margins for the original manufacturer and potentially for generic manufacturers if the market becomes highly competitive.

Pricing Benchmarks and Reimbursement

National Average Drug Acquisition Cost (NADAC)

The NADAC pricing benchmark, established by the Centers for Medicare & Medicaid Services (CMS), provides a more accurate and transparent estimate of drug prices paid by pharmacies. This benchmark helps in setting reimbursement rates and can influence the financial trajectory of prescription drugs by ensuring that Medicaid and other payers are not overpaying for drug ingredients[4].

Quality and Performance Metrics

Quality Measurement and Performance Payments

Quality measurement and performance payment programs, such as those implemented by CMS, can also impact the financial trajectory of prescription drugs. These programs incentivize providers to meet certain quality targets, which can affect the overall cost and effectiveness of drug treatments. For example, the Physician Group Practice Demonstration involved calculating performance payments based on cost savings and quality targets, which could indirectly influence drug prescribing patterns and costs[2].

Challenges and Opportunities

Regulatory Hurdles and Technological Advancements

The pharmaceutical drug delivery market faces challenges such as regulatory hurdles, the high cost of advanced drug delivery devices, and the risk of needlestick injuries. However, technological advancements and government initiatives to provide affordable drug delivery products offer significant opportunities for growth and innovation[3].

Patient Compliance and Comfort

The emphasis on patient comfort and compliance is another driving factor. Modern drug delivery technologies that improve patient outcomes and reduce side effects can enhance market penetration and financial performance for pharmaceutical companies[3].

Key Takeaways

• Regulatory Frameworks: Acts like the Hatch-Waxman Act and BPCIA are crucial for facilitating generic entry and reducing drug prices.
• Market Competition: Intermediaries like PBMs and GPOs significantly influence drug prices and market entry.
• Financial Pressures: Government and insurer pressures to lower drug prices impact the revenue potential for pharmaceutical companies.
• Pricing Benchmarks: Accurate pricing benchmarks like NADAC ensure transparency and fairness in drug reimbursement.
• Quality Metrics: Quality measurement and performance payment programs can influence drug prescribing patterns and costs.

FAQs

What is the impact of generic entry on branded drug prices?

Generic entry typically leads to a significant reduction in prices as competition increases, benefiting consumers but reducing the revenue and market share of the branded product.

How do intermediaries affect the pharmaceutical supply chain?

Intermediaries like PBMs and GPOs influence drug prices through contractual relationships with manufacturers and health plan sponsors, affecting reimbursement rates and formulary listings.

What are the key drivers of the pharmaceutical drug delivery market?

The key drivers include the increasing prevalence of chronic diseases, technological advancements in drug delivery systems, and the growing geriatric population.

How do regulatory frameworks influence the entry of generic drugs?

Regulatory frameworks like the Hatch-Waxman Act and BPCIA expedite generic drug entry by lowering patent-related barriers, thereby increasing competition and reducing drug prices.

What is the role of NADAC in drug pricing?

NADAC provides a transparent and accurate estimate of drug prices paid by pharmacies, helping in setting fair reimbursement rates and reducing the risk of overpayment by Medicaid and other payers.

Sources

1. Federal Trade Commission. Understanding Competition in Prescription Drug Markets: Entry and Supply Chain Dynamics.
2. Centers for Medicare & Medicaid Services. Physician Group Practice Demonstration Quality Measurement and Performance Payment Specifications.
3. MarketsandMarkets. Pharmaceutical Drug Delivery Market Growth, Drivers & Opportunities.
4. Centers for Medicare & Medicaid Services. Methodology for Calculating the National Average Drug Acquisition Cost (NADAC).