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IMCIVREE Drug Patent Profile

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

Imcivree is a drug marketed by Rhythm and is included in one NDA. There are three patents protecting this drug.

This drug has ninety-four patent family members in twenty-one countries.

The generic ingredient in IMCIVREE is setmelanotide acetate. Additional details are available on the setmelanotide acetate profile page.

DrugPatentWatch^® Generic Entry Outlook for Imcivree

Imcivree was eligible for patent challenges on November 25, 2024.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 4, 2034. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for IMCIVREE

International Patents:	94
US Patents:	3
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	19
Clinical Trials:	1
Drug Prices:	Drug price information for IMCIVREE
What excipients (inactive ingredients) are in IMCIVREE?	IMCIVREE excipients list
DailyMed Link:	IMCIVREE at DailyMed

See drug prices for IMCIVREE

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

NDA:

213793

Dosage:

SOLUTION;SUBCUTANEOUS

^*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 IMCIVREE

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

Sponsor	Phase
Rhythm Pharmaceuticals, Inc.	Phase 3

See all IMCIVREE clinical trials

US Patents and Regulatory Information for IMCIVREE

IMCIVREE is protected by three US patents and four FDA Regulatory Exclusivities.

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
Rhythm	IMCIVREE	setmelanotide acetate	SOLUTION;SUBCUTANEOUS	213793-001	Nov 25, 2020		RX	Yes	Yes			Y
Rhythm	IMCIVREE	setmelanotide acetate	SOLUTION;SUBCUTANEOUS	213793-001	Nov 25, 2020		RX	Yes	Yes
Rhythm	IMCIVREE	setmelanotide acetate	SOLUTION;SUBCUTANEOUS	213793-001	Nov 25, 2020		RX	Yes	Yes
Rhythm	IMCIVREE	setmelanotide acetate	SOLUTION;SUBCUTANEOUS	213793-001	Nov 25, 2020		RX	Yes	Yes			Y	Y
Rhythm	IMCIVREE	setmelanotide acetate	SOLUTION;SUBCUTANEOUS	213793-001	Nov 25, 2020		RX	Yes	Yes			Y	Y
Rhythm	IMCIVREE	setmelanotide acetate	SOLUTION;SUBCUTANEOUS	213793-001	Nov 25, 2020		RX	Yes	Yes
Rhythm	IMCIVREE	setmelanotide acetate	SOLUTION;SUBCUTANEOUS	213793-001	Nov 25, 2020		RX	Yes	Yes

International Patents for IMCIVREE

When does loss-of-exclusivity occur for IMCIVREE?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Denmark

European Patent Office

France

Hong Kong

Israel

Japan

Netherlands

Poland

Portugal

Russian Federation

South Korea

Spain

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

See the table below for additional patents covering IMCIVREE around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2022065117	医薬組成物
Hong Kong	1220702	藥物組合物 (PHARMACEUTICAL COMPOSITIONS)
South Korea	101232201
Australia	2021202699	Pharmaceutical compositions
Russian Federation	2439079	ЛИГАНДЫ РЕЦЕПТОРОВ МЕЛАНОКОРТИНОВ (MELANOCORTIN RECEPTOR LIGANDS)
Denmark	2286825
Spain	2825076

Supplementary Protection Certificates for IMCIVREE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2970389	53/2021	Austria		PRODUCT NAME: SETMELANOTID; REGISTRATION NO/DATE: EU/1/21/1564 (MITTEILUNG) 20210719
2236151	CA 2021 00053	Denmark		PRODUCT NAME: SETMELANOTID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/21/1564 20210719
2970389	2021C/551	Belgium		PRODUCT NAME: SETMELANOTIDE, ALSMEDE DOOR HET BASISOCTROOI BESCHERMDE, THERAPEUTISCH EQUIVALENTE AFGELEIDEN ERVAN; AUTHORISATION NUMBER AND DATE: EU/1/21/1564 20210719
2970389	CA 2021 00054	Denmark		PRODUCT NAME: SETMELANOTID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/21/1564 20210719
2970389	21C1059	France		PRODUCT NAME: SETMELANOTIDE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/21/1564 20210719
2970389	122021000083	Germany		PRODUCT NAME: SETMELANOTID; REGISTRATION NO/DATE: EU/1/21/1564 20210716
2970389	2190055-0	Sweden		PRODUCT NAME: SETMELANOTID; REG. NO/DATE: EU/1/21/1564 20210719

IMCIVREE Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for IMCIVREE (Setmelanotide)

Introduction to IMCIVREE

IMCIVREE, also known as setmelanotide, is a groundbreaking drug developed by Rhythm Pharmaceuticals for the treatment of rare melanocortin-4 receptor (MC4R) pathway diseases, including hyperphagia and severe obesity associated with conditions such as Bardet-Biedl syndrome (BBS) and other genetic disorders.

Market Expansion and Availability

As of 2024, IMCIVREE is available in 14 markets globally, marking a significant expansion in its reach. This widespread availability is a result of Rhythm Pharmaceuticals' strategic efforts to bring the drug to patients worldwide, particularly in regions where such treatments are scarce[3].

Revenue Growth

Quarterly and Annual Revenue

The financial performance of IMCIVREE has shown steady growth over the past few years. In the fourth quarter of 2023, net product revenues from IMCIVREE sales were $24.2 million, with total annual revenues reaching $77.4 million. This represents a substantial increase from the $8.8 million in the fourth quarter of 2022 and $16.9 million for the entire year of 2022[1].

In 2024, the revenue trend continued to be positive:

• First quarter 2024 revenues were $26.0 million, up from $11.5 million in the same period of 2023[3].
• Second quarter 2024 revenues stood at $29.1 million, an increase from $19.2 million in the second quarter of 2023[2].
• Third quarter 2024 revenues were $33.3 million, a 14% sequential increase from the second quarter of 2024[4].

Geographic Revenue Distribution

A significant portion of IMCIVREE's revenue is generated in the United States. For instance, in the fourth quarter of 2023, 76% of the net product revenue came from the U.S., while in the third quarter of 2024, this figure was 70%[1][4].

Research and Development (R&D) Expenses

Rhythm Pharmaceuticals has been investing heavily in R&D to expand the indications and reach of IMCIVREE. Here are some key points:

• In the second quarter of 2024, R&D expenses were $30.2 million, slightly lower than the $33.5 million in the same period of 2023, primarily due to decreased clinical trial costs[2].
• For the six months ended June 30, 2024, R&D expenses increased to $158.9 million, largely due to the acquisition of LG Chem’s proprietary compound LB54640 and increased costs associated with headcount and clinical trials[2].
• In the third quarter of 2024, R&D expenses were $37.9 million, up from $33.6 million in the third quarter of 2023, driven by increased costs in clinical product manufacturing and ongoing clinical trials[4].

Selling, General, and Administrative (SG&A) Expenses

SG&A expenses have also seen an upward trend, reflecting the company's efforts to support business and commercial operations:

• In the second quarter of 2024, SG&A expenses were $36.4 million, an increase from $30.0 million in the second quarter of 2023, due to increased headcount and professional services expenses[2].
• For the six months ended June 30, 2024, SG&A expenses were $70.8 million, up from $54.7 million in the same period of 2023, driven by increased headcount and marketing expenses[2].
• In the third quarter of 2024, SG&A expenses were $35.4 million, an increase from $30.5 million in the third quarter of 2023, attributed to increased headcount, marketing, and professional services costs[4].

Net Loss and Cash Position

Despite the revenue growth, Rhythm Pharmaceuticals has reported net losses:

• For the fourth quarter of 2023, the net loss was $41.6 million, and for the full year 2023, it was $184.7 million[1].
• In the second quarter of 2024, the net loss was $33.6 million, and for the six months ended June 30, 2024, it was $93.3 million[2].
• The third quarter of 2024 saw a net loss of $45.0 million[4].

However, the company's cash position remains strong:

• As of December 31, 2023, cash, cash equivalents, and short-term investments were approximately $275.8 million[1].
• By June 30, 2024, this figure increased to $319.1 million, and as of September 30, 2024, it was $298.4 million[2][4].

Clinical Trials and Regulatory Milestones

Rhythm Pharmaceuticals is actively engaged in several clinical trials and regulatory activities:

• The Phase 3 trial evaluating setmelanotide in hypothalamic obesity is on track for topline data readout in the first half of 2025. Dosing of the first patients in Japan is anticipated to have begun in the second quarter of 2024[2][3][4].
• A supplementary New Drug Application (sNDA) to expand the U.S. label of IMCIVREE to treat pediatric patients as young as 2 years old in approved indications was submitted in the second quarter of 2024 and accepted by the FDA for Priority Review with a PDUFA goal date of December 26, 2024[3][4].

Market Forecast and Competitive Landscape

The market for obesity treatments, particularly those targeting rare genetic disorders, is expected to grow significantly. According to market forecasts, the extensive research and incremental healthcare spending globally will expand the market size, enabling drug manufacturers like Rhythm Pharmaceuticals to penetrate deeper into the market[5].

Competitive Landscape

IMCIVREE operates in a niche market with limited competition for the specific indications it treats. However, the broader obesity market is competitive, with several emerging therapies. Rhythm Pharmaceuticals' focus on rare MC4R pathway diseases positions IMCIVREE as a unique offering with significant market potential[5].

Key Takeaways

• Revenue Growth: IMCIVREE has shown consistent revenue growth, with significant increases in both quarterly and annual sales.
• Geographic Distribution: The majority of revenue is generated in the United States, with growing contributions from international markets.
• R&D and SG&A Expenses: Increased investments in R&D and SG&A reflect the company's commitment to expanding the drug's indications and commercial reach.
• Clinical Trials and Regulatory Milestones: Ongoing Phase 3 trials and regulatory submissions are crucial for future growth and label expansions.
• Market Forecast: The market for obesity treatments is expected to grow, providing a favorable environment for IMCIVREE.

FAQs

What is IMCIVREE used for?

IMCIVREE (setmelanotide) is used to treat hyperphagia and severe obesity associated with rare melanocortin-4 receptor (MC4R) pathway diseases, such as Bardet-Biedl syndrome (BBS) and other genetic disorders.

How has IMCIVREE's revenue performed in recent years?

IMCIVREE has shown significant revenue growth, with net product revenues increasing from $16.9 million in 2022 to $77.4 million in 2023, and continuing to grow in 2024.

What are the key clinical trials and regulatory milestones for IMCIVREE?

The Phase 3 trial evaluating setmelanotide in hypothalamic obesity is on track for topline data readout in the first half of 2025. Additionally, a sNDA to expand the U.S. label to treat pediatric patients as young as 2 years old has been submitted and accepted by the FDA for Priority Review.

What is the current cash position of Rhythm Pharmaceuticals?

As of September 30, 2024, Rhythm Pharmaceuticals' cash, cash equivalents, and short-term investments were approximately $298.4 million.

How does IMCIVREE's market position look in the broader obesity treatment landscape?

IMCIVREE operates in a niche market with limited competition for its specific indications. The broader obesity market is competitive, but IMCIVREE's unique positioning and ongoing research activities position it for significant market potential.

Sources

1. Rhythm Pharmaceuticals Reports Fourth Quarter 2023 Financial Results and Business Update. Rhythm Pharmaceuticals.
2. Rhythm Pharmaceuticals Reports Second Quarter 2024 Financial Results and Business Update. Rhythm Pharmaceuticals.
3. Rhythm Pharmaceuticals Reports First Quarter 2024 Financial Results and Business Update. Biospace.
4. Rhythm Pharmaceuticals Reports Third Quarter 2024 Financial Results and Business Update. Biospace.
5. IMCIVREE (Setmelanotide), Drug Insight and Market Forecast - 2032. Research and Markets.