ERMEZA Drug Patent Profile

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

Ermeza is a drug marketed by Mylan and is included in one NDA. There is one patent protecting this drug.

This drug has seven patent family members in seven countries.

The generic ingredient in ERMEZA is levothyroxine sodium. There are ten drug master file entries for this compound. Fifty-one suppliers are listed for this compound. Additional details are available on the levothyroxine sodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Ermeza

A generic version of ERMEZA was approved as levothyroxine sodium by MYLAN on June 5^th, 2002.

Summary for ERMEZA

International Patents:	7
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Drug Prices:	Drug price information for ERMEZA
What excipients (inactive ingredients) are in ERMEZA?	ERMEZA excipients list
DailyMed Link:	ERMEZA at DailyMed

See drug prices for ERMEZA

Pharmacology for ERMEZA

Drug Class

l-Thyroxine

US Patents and Regulatory Information for ERMEZA

ERMEZA 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
Mylan	ERMEZA	levothyroxine sodium	SOLUTION;ORAL	215809-001	Apr 29, 2022		RX	Yes	Yes	9,345,772		Y

International Patents for ERMEZA

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

Country	Patent Number	Title	Estimated Expiration
Spain	2814129
Croatia	P20201354
European Patent Office	3261676	FORMULATIONS LIQUIDES DE LÉVOTHYROXINE (LIQUID LEVOTHYROXINE FORMULATIONS)
Montenegro	03810	TEKUĆE FORMULACIJE LEVOTIROKSINA (LIQUID LEVOTHYROXINE FORMULATIONS)
World Intellectual Property Organization (WIPO)	2016137969
Hungary	E050783
Slovenia	3261676

ERMEZA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ERMEZA

Introduction to ERMEZA

ERMEZA is a levothyroxine sodium oral solution indicated for the treatment of hypothyroidism in adult and pediatric patients, including neonates. It is used as replacement therapy in primary, secondary, and tertiary congenital or acquired hypothyroidism, as well as for the suppression of thyrotropin-dependent well-differentiated thyroid cancer[4].

Market Context: Endocrinology Drugs Market

The endocrinology drugs market, within which ERMEZA operates, is experiencing significant growth. This market expanded from USD 32.78 billion in 2023 to USD 35.05 billion in 2024 and is projected to reach USD 53.85 billion by 2030, growing at a CAGR of 7.34%[3].

Key Market Drivers

Several factors are driving the growth of the endocrinology drugs market, including:

• Increasing Prevalence of Endocrine Disorders: The rising incidence of endocrine disorders such as hypothyroidism contributes to the demand for drugs like ERMEZA[3].
• Growing Awareness and Proactive Screening: Increased awareness and proactive screening for hormonal disorders further boost the market expansion[3].
• Aging Population and Lifestyle Changes: The growing aging population and lifestyle changes that contribute to the rise in endocrine disorders also drive market growth[3].

Market Opportunities for ERMEZA

• Personalized Medicine and Targeted Therapies: The increasing focus on personalized medicine and targeted therapies presents opportunities for ERMEZA, especially given its dose-flexible liquid formulation which can be tailored to individual patient needs[3][4].
• Advancements in Biotechnology: Innovations in drug formulations, such as long-acting and biologic drugs, and the integration of digital health technologies, can enhance the treatment outcomes and patient compliance for ERMEZA[3].

Challenges and Restraints

Despite the opportunities, the market for ERMEZA faces several challenges:

• High Development Costs: The high cost associated with the research and development of endocrinology drugs can be a significant barrier[3].
• Stringent Regulatory Requirements: The stringent regulatory requirements for drug approval can delay product launches and impact market entry[3].
• Price Sensitivity and Generic Competition: Price sensitivity and competition from generic alternatives can also pose challenges to the financial trajectory of ERMEZA[3].

Financial Performance and Trajectory

While specific financial data for ERMEZA is not provided, we can infer some insights from the broader market and related pharmaceutical trends:

• Revenue Potential: Given the growing demand for endocrinology drugs, ERMEZA has the potential to generate significant revenue. The market's projected growth to USD 53.85 billion by 2030 indicates a favorable financial trajectory for drugs in this category[3].
• Competitive Landscape: Companies like Impel Pharmaceuticals, which have seen significant growth in their product revenues (e.g., Trudhesa's 149% increase in net product revenue from Q1 2022 to Q1 2023), demonstrate the potential for successful commercialization of specialized drugs[2].

Dosing and Compliance

ERMEZA's dosing flexibility and the need for individualized treatment plans can impact its financial performance. The drug's narrow therapeutic index requires careful dosing and monitoring, which can affect patient compliance and, consequently, revenue stability. However, this also presents an opportunity for continuous patient engagement and monitoring, potentially leading to sustained revenue streams[1][4].

Patient and Prescriber Dynamics

The success of ERMEZA also depends on patient and prescriber dynamics. Factors such as reimbursement rates, refill rates, and prescriber feedback are crucial. For instance, Impel Pharmaceuticals' Trudhesa saw a 72% reimbursement rate in Q1 2023, indicating strong market acceptance and financial viability[2].

Strategic Considerations

To maximize the financial trajectory of ERMEZA, the following strategies are essential:

• Strategic Partnerships: Collaborations with healthcare providers, patient advocacy groups, and other stakeholders can enhance market penetration and patient compliance[3].
• Regulatory Compliance: Ensuring strict adherence to regulatory requirements is critical to avoid delays and ensure smooth market entry[3].
• Technological Advancements: Leveraging advancements in drug delivery systems and digital health technologies can improve treatment outcomes and patient satisfaction, leading to better financial performance[3].

Key Takeaways

• ERMEZA operates in a growing endocrinology drugs market driven by increasing prevalence of endocrine disorders and advancements in biotechnology.
• The drug's dose-flexible formulation and individualized treatment plans offer opportunities for personalized medicine.
• Challenges include high development costs, stringent regulatory requirements, and price sensitivity.
• Strategic partnerships, regulatory compliance, and leveraging technological advancements are crucial for maximizing the financial trajectory of ERMEZA.

FAQs

Q: What is ERMEZA used for? ERMEZA is used as replacement therapy for primary, secondary, and tertiary congenital or acquired hypothyroidism, as well as for the suppression of thyrotropin-dependent well-differentiated thyroid cancer[4].

Q: What are the key drivers of the endocrinology drugs market? The key drivers include the increasing prevalence of endocrine disorders, growing awareness and proactive screening, and an aging population with lifestyle changes contributing to the rise in endocrine disorders[3].

Q: What challenges does ERMEZA face in the market? ERMEZA faces challenges such as high development costs, stringent regulatory requirements, and price sensitivity along with generic competition[3].

Q: How does the dosing flexibility of ERMEZA impact its financial performance? The dosing flexibility of ERMEZA allows for individualized treatment plans, which can impact patient compliance and revenue stability. It also presents opportunities for continuous patient engagement and monitoring, potentially leading to sustained revenue streams[1][4].

Q: What strategies can enhance the financial trajectory of ERMEZA? Strategies such as strategic partnerships, ensuring regulatory compliance, and leveraging technological advancements in drug delivery systems and digital health technologies can enhance the financial trajectory of ERMEZA[3].

Cited Sources

1. FDA Label for ERMEZA: Accessdata.fda.gov
2. Impel Pharmaceuticals Financial Results: Biospace.com
3. Endocrinology Drugs Market Analysis: Globenewswire.com
4. ERMEZA Product Information: Ermezahcp.com