REZDIFFRA Drug Patent Profile

When do Rezdiffra patents expire, and what generic alternatives are available?

Rezdiffra is a drug marketed by Madrigal and is included in one NDA. There are five patents protecting this drug.

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

The generic ingredient in REZDIFFRA is resmetirom. One supplier is listed for this compound. Additional details are available on the resmetirom profile page.

DrugPatentWatch^® Generic Entry Outlook for Rezdiffra

Rezdiffra will be eligible for patent challenges on March 14, 2028. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 14, 2029. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for REZDIFFRA

International Patents:	106
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Applications:	63
Drug Prices:	Drug price information for REZDIFFRA
What excipients (inactive ingredients) are in REZDIFFRA?	REZDIFFRA excipients list
DailyMed Link:	REZDIFFRA at DailyMed

See drug prices for REZDIFFRA

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

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

NDA:

217785

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.

US Patents and Regulatory Information for REZDIFFRA

REZDIFFRA is protected by five US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on NEW CHEMICAL ENTITY.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	217785-003	Mar 14, 2024		RX	Yes	Yes
Madrigal	REZDIFFRA	resmetirom	TABLET;ORAL	217785-002	Mar 14, 2024		RX	Yes	No

International Patents for REZDIFFRA

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

Country	Patent Number	Title	Estimated Expiration
Taiwan	I804870
South Africa	200800405	PYRISAZINONE DERIVATIVES AS THYROID HORMONE RECEPTOR AGONISTS
Japan	6765408

REZDIFFRA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Rezdiffra

Introduction to Rezdiffra

Rezdiffra, developed by Madrigal Pharmaceuticals, is a groundbreaking drug approved by the FDA in March 2024 for the treatment of non-cirrhotic non-alcoholic steatohepatitis (NASH) with moderate to advanced liver fibrosis, now commonly referred to as Metabolic Associated Steatohepatitis (MASH). This approval marks a significant milestone as Rezdiffra is the first oral treatment for this indication.

Market Potential and Growth

Rising Diagnosis Rates of MASH

The market potential for Rezdiffra is substantial, driven largely by the increasing diagnosis rates of MASH. As awareness and diagnostic techniques improve, the pool of potential patients is expected to expand significantly. Analysts project that rising diagnosis rates could lead to earlier identification of F2/F3 MASH patients, aligning perfectly with Rezdiffra's target population and driving a surge in prescriptions[4].

Early Adoption and Prescription Rates

Since its launch, Rezdiffra has seen strong early demand and adoption. According to Madrigal's earnings call, over 2,000 patients were on Rezdiffra, with approximately 20% of top targets writing a Rezdiffra prescription. The drug's prescription rate is on par with that of established treatments like tirzepatide, despite being available for a shorter period[4].

Patient and Prescriber Growth

Data from Earnest's Phoenix dataset indicates that Rezdiffra's patient count grew 16 times since April 2024, with unique prescribers increasing by 13 times during the same period. The growth in repeat prescriptions has been particularly significant, contributing to the overall expansion of Rezdiffra's user base[1].

Financial Performance and Outlook

Revenue and Profit Trends

Madrigal recorded $62.2 million in product revenue for the third quarter of 2024, with total net product revenue for the first nine months of the year totaling $76.8 million. This strong initial commercial performance reflects the significant unmet medical need for effective MASH treatments and Madrigal’s successful launch execution[5].

Projected Revenue and Peak Sales

Analysts project that Rezdiffra could achieve peak sales of $6-$7.4 billion, targeting approximately 5% of the suspected F2/F3 MASH population in the United States. This estimate is based on the drug's unique position as the first oral treatment for MASH and the growing prevalence of the disease[2].

Financial Challenges and Investments

Despite the revenue growth, Madrigal reported a net loss of $107.0 million in Q3 2024 and $406.5 million for the first nine months of the year. The company continues to invest heavily in research and development, as well as commercial activities, which has resulted in significant operating losses. Selling, general, and administrative expenses surged to $107.6 million in Q3 2024, driven by the investments required to support the commercial launch of Rezdiffra[5].

Competitive Landscape

First-Mover Advantage

Madrigal currently enjoys a first-mover advantage in the oral MASH treatment market. Rezdiffra's approval and strong early adoption have positioned the company as a leader in addressing this growing health concern[4].

Potential Competition from GLP-1 Drugs

GLP-1 drugs, such as tirzepatide and survodutide, are being studied in MASH with promising phase II clinical trial results. While these drugs could potentially alter Rezdiffra’s growth trajectory, analysts note that they have shown inconsistent clinical outcomes in fibrosis improvement, which may limit their impact on Rezdiffra's market share[1][2].

Impact of GLP-1 Use on Rezdiffra

Approximately 35% of patients starting Rezdiffra had a recent history of GLP-1 use, which is higher than the 14% observed in clinical trials. This suggests that a significant portion of current patients would not immediately qualify for a Rezdiffra prescription if a GLP-1 step-through requirement were implemented[1].

Reimbursement and Insurance Coverage

Improving Reimbursement Landscape

The reimbursement landscape for Rezdiffra is improving, with major insurers like Cigna and United Healthcare establishing favorable prior authorization requirements. Madrigal aims to have 80% of commercial lives covered by the end of 2024, which could significantly boost accessibility and sales[2].

SWOT Analysis

Strengths

• First-Mover Advantage: Rezdiffra is the first oral treatment for MASH, giving Madrigal a significant market lead.
• Strong Early Demand: The drug has seen strong adoption among healthcare providers.
• Comparable Efficacy: Rezdiffra's efficacy is on par with established metabolic treatments[4].

Weaknesses

• High R&D Expenses: Significant investments in research and development are impacting short-term valuation.
• Complex Reimbursement Process: The reimbursement process for Rezdiffra remains complex.
• Time Lag Between Prescription and First Dose: There is a notable time lag between prescription and first dose administration[4].

Opportunities

• Growing MASH Market: Increasing diagnosis rates of MASH represent a significant growth opportunity.
• Potential Expansion of Indications: The potential inclusion in treatment guidelines and expansion into related indications or combination therapies could increase the drug's market size[4].

Threats

• Potential Competition: The potential approval of GLP-1 drugs in MASH could impact Rezdiffra’s commercial trajectory.
• Concentration Risk: Madrigal’s reliance on a single product, Rezdiffra, represents a concentration risk[4].

Key Takeaways

• Rapid Adoption: Rezdiffra has seen rapid adoption with over 2,000 patients and a significant increase in prescriptions and unique prescribers.
• Financial Growth: Despite initial losses, Madrigal is projected to achieve significant revenue growth, with peak sales estimated between $6-$7.4 billion.
• Competitive Landscape: The potential competition from GLP-1 drugs and the need for continued investment in research and development are key factors to watch.
• Improving Reimbursement: Favorable reimbursement policies from major insurers are expected to boost accessibility and sales.

FAQs

What is Rezdiffra and its significance in the treatment of MASH?

Rezdiffra is the first oral treatment approved for adults with non-cirrhotic non-alcoholic steatohepatitis (MASH) with liver scarring. Its significance lies in addressing a significant unmet medical need for effective MASH treatments.

How has Rezdiffra performed since its launch?

Since its launch, Rezdiffra has seen strong early demand and adoption, with a 16-fold increase in patient count and a 13-fold increase in unique prescribers from April to August 2024.

What is the projected peak sales for Rezdiffra?

Analysts project that Rezdiffra could achieve peak sales of $6-$7.4 billion, targeting approximately 5% of the suspected F2/F3 MASH population in the United States.

How does the use of GLP-1 drugs impact Rezdiffra’s market?

Approximately 35% of patients starting Rezdiffra had a recent history of GLP-1 use. While GLP-1 drugs could alter Rezdiffra’s growth trajectory, their inconsistent clinical outcomes in fibrosis improvement may limit their impact.

What are the key financial challenges facing Madrigal Pharmaceuticals?

Madrigal faces significant operating losses due to heavy investments in research and development and commercial activities. The company’s profitability will likely remain challenged in the near term as it prioritizes growth over bottom-line performance.

Sources

1. Earnest Analytics: Madrigal cultivates Rezdiffra's foothold in MASH as GLP-1 competitor.
2. Investing.com: Madrigal Pharmaceuticals' SWOT analysis: Rezdiffra launch fuels stocks potential.
3. FiercePharma: Sales strong for Madrigal's Rezdiffra, but shares down 13%.
4. Investing.com: Madrigal Pharmaceuticals' SWOT analysis: Rezdiffra's potential drives stock outlook.
5. Webull: Madrigal Pharmaceuticals reports financial results for Q3 2024.