Resmetirom - Generic Drug Details

What are the generic drug sources for resmetirom and what is the scope of freedom to operate?

Resmetirom is the generic ingredient in one branded drug marketed by Madrigal and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Resmetirom has one hundred and six patent family members in thirty-four countries.

One supplier is listed for this compound.

Summary for resmetirom

International Patents:	106
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	4
Patent Applications:	97
What excipients (inactive ingredients) are in resmetirom?	resmetirom excipients list
DailyMed Link:	resmetirom at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for resmetirom

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for resmetirom

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

Sponsor	Phase
Madrigal Pharmaceuticals, Inc.	Phase 3

See all resmetirom clinical trials

Pharmacology for resmetirom

Drug Class	Thyroid Hormone Receptor beta Agonist
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Cytochrome P450 2C8 Inhibitors Organic Anion Transporting Polypeptide 1B1 Inhibitors Organic Anion Transporting Polypeptide 1B3 Inhibitors Thyroid Hormone Receptor beta Agonists

US Patents and Regulatory Information for resmetirom

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Madrigal	REZDIFFRA	resmetirom	TABLET;ORAL	217785-001	Mar 14, 2024		RX	Yes	No
Madrigal	REZDIFFRA	resmetirom	TABLET;ORAL	217785-002	Mar 14, 2024		RX	Yes	No	11,986,481
Madrigal	REZDIFFRA	resmetirom	TABLET;ORAL	217785-003	Mar 14, 2024		RX	Yes	Yes
Madrigal	REZDIFFRA	resmetirom	TABLET;ORAL	217785-003	Mar 14, 2024		RX	Yes	Yes	7,452,882		Y	Y
Madrigal	REZDIFFRA	resmetirom	TABLET;ORAL	217785-002	Mar 14, 2024		RX	Yes	No
Madrigal	REZDIFFRA	resmetirom	TABLET;ORAL	217785-003	Mar 14, 2024		RX	Yes	Yes	9,266,861		Y	Y

International Patents for resmetirom

Country	Patent Number	Title	Estimated Expiration
Brazil	122021024202	Processo sintético compreendendo compostos de piridazinona bem como os ditos compostos
Australia	2006271721	Pyridazinone derivatives as thyroid hormone receptor agonists
Israel	314360	שיטה לסינתזת אנלוגים להורמון בלוטת התריס ופולימורפים שלהם (Method of synthesizing thyroid hormone analogs and polymorphs thereof)
Cyprus	1110929
Japan	6899413
Canada	2884481	PROCEDE DE SYNTHESE D'ANALOGUES DE L'HORMONE THYROIDIENNE ET DE SES POLYMORPHES (METHOD OF SYNTHESIZING THYROID HORMONE ANALOGS AND POLYMORPHS THEREOF)

Market Dynamics and Financial Trajectory for Resmetirom

Introduction to Resmetirom

Resmetirom, developed by Madrigal Pharmaceuticals, is a groundbreaking drug designed to treat non-alcoholic steatohepatitis (NASH) with moderate-to-advanced liver fibrosis. Recently approved by the FDA in March 2024, resmetirom marks a significant milestone in the treatment of this debilitating liver disease.

Market Opportunity for Resmetirom

The market potential for resmetirom is substantial, driven by the unmet need for effective therapies in the NASH treatment landscape. Here are some key points:

• Prevalence of NASH: The disease affects a large population, with approximately 4.5 million patients in the U.S. alone having fibrosis stages F2 and F3, which are the target stages for resmetirom[2][3].
• Global Market: The global market for NASH treatments is projected to be significant, with estimates suggesting it could be worth up to $15 billion by 2027[4].
• European and International Markets: Beyond the U.S., resmetirom has compelling opportunities in Europe and other key international markets, further expanding its potential market reach[3].

Financial Impact and Budget Analysis

The financial implications of introducing resmetirom into the market are multifaceted:

• Budget Impact Analysis: A study conducted to assess the budget impact of resmetirom on a hypothetical private health plan in the U.S. revealed that while the drug increases overall costs, it also offers potential cost savings by slowing disease progression. The net budget impact ranged from $2.2 to $9.5 million over three years, with a per-member per-month (PMPM) impact of $0.19 to $0.80[1].
• Cost Components: The costs associated with resmetirom include drug acquisition, diagnosis and monitoring, and other medical and prescription costs. Sensitivity analyses showed that results were most sensitive to diagnostic and epidemiologic inputs[1].

Payer Challenges and Utilization Management

Payers are expected to implement various utilization management strategies due to the drug's potential financial impact:

• Utilization Hurdles: Payers will likely erect hurdles such as prior authorizations and appeals processes to manage the financial burden of resmetirom. Effective patient support services by Madrigal Pharmaceuticals will be crucial in helping physicians navigate these challenges[2].
• Demand Generation: The success of resmetirom will depend on generating demand among physicians and patients. This involves creating buy-in about the drug's clinical value and supporting tools to facilitate the reimbursement process[2].

Clinical and Business Updates

Madrigal Pharmaceuticals has made significant strides in the clinical and commercial development of resmetirom:

• Clinical Trials: Resmetirom has shown promising efficacy and safety in clinical trials, including the Phase 3 MAESTRO-NASH trial. The drug has received the FDA's Breakthrough Therapy designation, which accelerates its development and review process[4][5].
• Financial Position: Madrigal has a strong cash position and manageable debt, with a $250 million term loan facility to support the clinical and commercial development of resmetirom. As of June 2023, the company had $298.4 million in liquid assets, providing an approximately 11.2-month cash runway[4][5].

Revenue Expectations and Market Projections

Analysts have high expectations for resmetirom's revenue potential:

• Peak Sales Projections: Revenue forecasts for resmetirom range from over a billion dollars to as high as $17 billion, depending on the pricing strategy. At a price of $15,000 per patient, the market could be valued at $6.5 billion, while a price of $40,000 could result in a $17 billion market[2].
• Market Share: The success of resmetirom in capturing a significant portion of the NASH market will depend on various factors, including its performance in clinical trials, regulatory approvals, and the ability to navigate payer challenges[4].

Risks and Challenges

Despite the promising outlook, there are several risks and challenges that Madrigal Pharmaceuticals faces:

• Regulatory Uncertainty: The FDA's approval process is uncertain, and any delays or failures could impact the company's prospects and stock performance[4].
• Rising R&D Costs: Madrigal is facing increasing research and development costs, which could necessitate additional financing. The company reported a net loss in recent financial statements[4][5].
• Competition: The NASH therapeutic field is highly competitive, with several companies developing promising drug candidates. If a competitor gains approval before Madrigal, it could affect resmetirom's market share[4].

Key Takeaways

• Significant Market Opportunity: Resmetirom addresses a substantial unmet need in the NASH treatment market, with a potential global market value of up to $15 billion.
• Financial Impact: While resmetirom increases overall costs, it offers potential cost savings by slowing disease progression.
• Payer Challenges: Effective patient support services and demand generation strategies are crucial to navigate payer hurdles.
• Strong Clinical and Financial Position: Madrigal Pharmaceuticals has a solid cash position and promising clinical trial results, but faces challenges such as rising R&D costs and regulatory uncertainty.

FAQs

Q: What is the primary indication for resmetirom?

A: Resmetirom is indicated for the treatment of adults with non-cirrhotic non-alcoholic steatohepatitis (NASH) with moderate-to-advanced liver fibrosis.

Q: How significant is the market potential for resmetirom?

A: The market potential for resmetirom is substantial, with estimates suggesting it could be worth up to $15 billion by 2027.

Q: What are the key challenges faced by Madrigal Pharmaceuticals in commercializing resmetirom?

A: Madrigal faces challenges such as regulatory uncertainty, rising R&D costs, competition in the NASH therapeutic field, and navigating payer utilization management hurdles.

Q: How does resmetirom impact healthcare costs?

A: While resmetirom increases overall costs due to its price, it also offers potential cost savings by slowing disease progression and reducing the need for other medical interventions.

Q: What is the current financial position of Madrigal Pharmaceuticals?

A: Madrigal has a strong cash position and manageable debt, with a $250 million term loan facility and approximately $298.4 million in liquid assets as of June 2023.

Sources

1. PubMed: "Budget impact of resmetirom for the treatment of adults with non-cirrhotic non-alcoholic steatohepatitis (NASH) with moderate-to-advanced liver fibrosis and estimated total costs for a hypothetical private payer in the United States."
2. BioCentury: "Madrigal's payer challenges will really be demand challenges and Madrigal is not alone."
3. Madrigal Pharmaceuticals: "Phase 3 development of resmetirom, a liver-directed thyroid hormone receptor beta agonist."
4. Seeking Alpha: "Madrigal's Resmetirom Nears Commercialization Despite Market Concerns."
5. Madrigal Pharmaceuticals: "Madrigal Pharmaceuticals Provides Clinical and Business Updates and Reports 2022 First Quarter Financial Results."

Last updated: 2024-12-17