TEPYLUTE Drug Patent Profile

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

Tepylute is a drug marketed by Shorla and is included in one NDA. There is one patent protecting this drug.

This drug has two patent family members in one country.

The generic ingredient in TEPYLUTE is thiotepa. There are eleven drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the thiotepa profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Tepylute

A generic version of TEPYLUTE was approved as thiotepa by WEST-WARD PHARMS INT on April 2^nd, 2001.

Summary for TEPYLUTE

International Patents:	2
US Patents:	1
Applicants:	1
NDAs:	1
DailyMed Link:	TEPYLUTE at DailyMed

US Patents and Regulatory Information for TEPYLUTE

TEPYLUTE is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Shorla	TEPYLUTE	thiotepa	SOLUTION;INTRAVENOUS	216984-001	Jun 25, 2024		RX	Yes	Yes	11,975,013		Y

International Patents for TEPYLUTE

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2022038490
World Intellectual Property Organization (WIPO)	2023156911

TEPYLUTE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for TEPYLUTE

Introduction

TEPYLUTE, a novel formulation of thiotepa, has recently received FDA approval for the treatment of breast and ovarian cancer. This ready-to-dilute formulation addresses significant unmet needs in oncology, particularly in terms of ease of preparation and dosing accuracy. Here, we delve into the market dynamics and financial trajectory of TEPYLUTE.

Market Need and Patient Population

The approval of TEPYLUTE comes at a time when there is a high demand for effective and user-friendly cancer treatments. According to the American Cancer Society, over 300,000 women are expected to be diagnosed with breast cancer in the U.S. in 2024, and approximately 19,680 women will be diagnosed with ovarian cancer[1].

Competitive Landscape

The oncology market, particularly for breast and ovarian cancer treatments, is highly competitive. However, TEPYLUTE stands out due to its innovative formulation. Unlike the traditional lyophilized powder formulation of thiotepa, TEPYLUTE is a liquid form that eliminates the need for complex and time-consuming reconstitution, reducing the risk of preparation errors and medical personnel exposure to hazardous drugs[1].

Economic Impact of Innovative Formulations

The development and approval of TEPYLUTE reflect broader trends in pharmaceutical innovation. Drugs targeting small patient populations, such as those with specific genetic mutations, often command higher prices due to their high value to patients and the lack of generic competition. This is evident in the case of orphan drugs, where the potential value created justifies high research and development investments and resulting prices[3].

Pricing and Cost-Effectiveness

Pricing strategies for TEPYLUTE will likely consider the cost-effectiveness and financial burden on patients. Given that PARP inhibitors, another class of cancer drugs, have significant financial implications due to high co-pays, TEPYLUTE's pricing will need to balance between profitability and patient affordability. The use of medication assistance programs and negotiations with payers will be crucial in making TEPYLUTE accessible to a wider patient population[2].

Financial Projections

The financial trajectory of TEPYLUTE is promising due to several factors:

• Market Size: The large patient population for breast and ovarian cancer ensures a significant market size.
• Competitive Advantage: The ease of use and accuracy of dosing provided by TEPYLUTE are likely to attract a substantial share of the market.
• Regulatory Approval: The FDA approval is a critical milestone, indicating the drug's safety and efficacy, which can enhance market confidence and adoption[1].

Revenue Potential

Given that peptide drugs, a category to which TEPYLUTE belongs, occupy a distinct pharmaceutical space with significant revenue potential, TEPYLUTE is poised to contribute substantially to Shorla Oncology's revenue. The global peptide therapeutics market has shown steady growth, with an average annual growth rate of 7.7%, and global sales exceeding $50 billion in 2019[4].

Impact of COVID-19 on Market Dynamics

The COVID-19 pandemic has introduced new challenges and opportunities in the oncology market. Telehealth and remote visits have become more prevalent, and there is a push for treatments that can be administered outside of infusion centers to reduce the risk of exposure. TEPYLUTE, being an injectable product that can be prepared "just in time," aligns well with these new market dynamics[5].

Supply Chain and Regulatory Considerations

To ensure the financial success of TEPYLUTE, Shorla Oncology must mitigate potential supply chain disruptions and drug shortages. The company will need to work closely with regulatory bodies and implement contingency plans to address any acute shortages, as recommended by ASCO and other healthcare organizations[5].

Launch Plans and Commercial Strategy

Shorla Oncology's commercial strategy for TEPYLUTE will be crucial in determining its financial trajectory. The company plans to provide updates on its launch plans, which will likely include targeted marketing, educational programs for healthcare providers, and patient assistance initiatives to ensure broad access to the drug[1].

Key Takeaways

• Innovative Formulation: TEPYLUTE's ready-to-dilute formulation addresses significant unmet needs in oncology.
• Market Size: The drug targets a large patient population for breast and ovarian cancer.
• Competitive Advantage: Ease of use and accurate dosing are key differentiators.
• Financial Projections: Promising due to market size, competitive advantage, and regulatory approval.
• COVID-19 Impact: Aligns with new market dynamics favoring treatments that reduce exposure risks.
• Supply Chain and Regulatory Considerations: Mitigating supply chain disruptions is crucial.

FAQs

What is TEPYLUTE and how does it differ from existing formulations of thiotepa?

TEPYLUTE is a ready-to-dilute formulation of thiotepa, designed to treat breast and ovarian cancer. Unlike the traditional lyophilized powder formulation, TEPYLUTE is a liquid form that eliminates the need for complex reconstitution, reducing preparation time and the risk of drug preparation errors[1].

How does the FDA approval of TEPYLUTE impact Shorla Oncology?

The FDA approval of TEPYLUTE represents a significant milestone for Shorla Oncology, marking the company's first in-house developed New Drug Application (NDA) approval. This approval enhances the company's credibility and market presence in the oncology sector[1].

What are the key benefits of TEPYLUTE for healthcare providers and patients?

TEPYLUTE offers several benefits, including easier preparation, accurate dosing, and reduced exposure to hazardous drugs for medical personnel. It also allows for "just in time" preparation, which can improve patient care and safety[1].

How does the COVID-19 pandemic influence the market dynamics for TEPYLUTE?

The COVID-19 pandemic has increased the demand for treatments that can be administered outside of infusion centers to reduce exposure risks. TEPYLUTE, being an injectable product that can be prepared "just in time," aligns well with these new market dynamics[5].

What are the financial implications of TEPYLUTE for patients and healthcare systems?

The financial implications include potential high costs due to the innovative formulation and the lack of generic competition. However, Shorla Oncology may implement patient assistance programs and negotiate with payers to make TEPYLUTE more accessible[2].

Sources

1. Biospace: Shorla Oncology Announces FDA Approval for TEPYLUTE, A Novel Formulation to Treat Breast and Ovarian Cancer.
2. Pharmacy Times: Practice Pearl 1: Treatment Selection of PARP Inhibitors in Ovarian Cancer.
3. NBER: The Economics of Drug Development: Pricing and Innovation in a Changing Market.
4. University of Vienna: Trends in Peptide Drug Discovery.
5. Targeted Oncology: Cancer Care Resilience After COVID-19: Plans and Initiatives from ASCO.