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AGAMREE Drug Patent Profile

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

Agamree is a drug marketed by Catalyst Pharms and is included in one NDA. There are six patents protecting this drug.

This drug has forty-six patent family members in twenty-two countries.

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

DrugPatentWatch^® Generic Entry Outlook for Agamree

Agamree will be eligible for patent challenges on October 26, 2027. 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 October 26, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for AGAMREE

International Patents:	46
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Drug Prices:	Drug price information for AGAMREE
What excipients (inactive ingredients) are in AGAMREE?	AGAMREE excipients list
DailyMed Link:	AGAMREE at DailyMed

See drug prices for AGAMREE

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

Constraining patent/regulatory exclusivity:

TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) IN PATIENTS 2 YEARS OF AGE AND OLDER

NDA:

215239

Dosage:

SUSPENSION;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 AGAMREE

AGAMREE is protected by six US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) IN PATIENTS 2 YEARS OF AGE AND OLDER.

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
Catalyst Pharms	AGAMREE	vamorolone	SUSPENSION;ORAL	215239-001	Oct 26, 2023		RX	Yes	Yes	11,690,853
Catalyst Pharms	AGAMREE	vamorolone	SUSPENSION;ORAL	215239-001	Oct 26, 2023		RX	Yes	Yes
Catalyst Pharms	AGAMREE	vamorolone	SUSPENSION;ORAL	215239-001	Oct 26, 2023		RX	Yes	Yes	8,334,279

International Patents for AGAMREE

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

Country	Patent Number	Title	Estimated Expiration
China	103536599	Non-hormonal steroid modulators of nf-kb for treatment of disease
New Zealand	603107	Non-hormonal steroid modulators of nf-kb for treatment of disease
Spain	2548138

Supplementary Protection Certificates for AGAMREE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2805720	301273	Netherlands		PRODUCT NAME: VAMOROLONE; REGISTRATION NO/DATE: EU/1/23/1776 20231215
2805720	CA 2024 00018	Denmark		PRODUCT NAME: VAMOROLONE; REG. NO/DATE: EU/1/23/1776 20231215

AGAMREE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for AGAMREE (Vamorolone)

Introduction

AGAMREE (vamorolone) is a groundbreaking drug approved by the U.S. Food and Drug Administration (FDA) for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older. This article delves into the market dynamics and financial trajectory of AGAMREE, highlighting its approval, commercialization, financial performance, and future outlook.

FDA Approval and Regulatory Milestones

AGAMREE received FDA approval on October 26, 2023, based on data from the pivotal VISION-DMD study and additional safety information from open-label studies[1][4].

• This approval marked a significant milestone, making AGAMREE the first drug fully approved in both the U.S. and Europe for the treatment of DMD, pending European Commission approval expected in late 2023[1].

Commercialization and Launch

Catalyst Pharmaceuticals, Santhera's partner for North America, launched AGAMREE in the U.S. in March 2024, following the FDA approval. This launch is part of a broader strategy to make AGAMREE available globally, with the first global market introduction in Germany in January 2024[4].

Licensing Agreements and Partnerships

Santhera has entered into exclusive licensing agreements with Catalyst Pharmaceuticals for North America and Sperogenix Therapeutics for China. These agreements include sales-based milestones and royalties, with Catalyst assuming Santhera’s third-party royalty obligations in North America[1][2].

• The agreement with Catalyst includes up to USD 105 million in sales-based milestones and low-teen percentage royalties[4].

Market Demand and Payer Landscape

AGAMREE has seen strong demand since its launch, with a favorable payer landscape contributing to increased revenue guidance.

• In its second quarter post-launch, AGAMREE generated $15 million in net revenues, and Catalyst raised its full-year 2024 revenue guidance for AGAMREE to $40 million to $45 million[3].

Financial Performance

Santhera Pharmaceuticals

• In 2023, Santhera reported total revenue of CHF 103.4 million, significantly boosted by licensing income from the agreements with Catalyst and Sperogenix Therapeutics[2].
• The company reduced near-term liabilities and extended its cash reach into 2025, excluding maturing convertible bonds. Santhera aims to break even on a cash basis by the first half of 2026[2].

Catalyst Pharmaceuticals

• Catalyst reported a 25.3% increase in its third-quarter 2024 revenues, driven by strong sales of FIRDAPSE and AGAMREE. Total revenues rose to $128.7 million, with AGAMREE contributing $15 million in its second quarter post-launch[3].
• The company raised its full-year revenue guidance to $475 million to $485 million, reflecting confidence in continued product demand. Catalyst has a strong cash position with $442.3 million in cash and cash equivalents[3].

Revenue Projections and Guidance

• For 2024, Catalyst updated its full-year revenue guidance for AGAMREE to $40 million to $45 million, driven by strong demand and a favorable payer landscape[3].
• The company is also expanding its global reach, with AGAMREE seeking approval in Canada and FIRDAPSE approved in Japan[3].

Clinical and Development Activities

Santhera is advancing clinical initiatives to further investigate AGAMREE’s safety and efficacy.

• New studies include a broader patient age group (2 to 18 years), a Phase 1 study in healthy volunteers to confirm mineralocorticoid antagonistic properties, and a Phase 2 pilot study in Becker muscular dystrophy (BMD)[5].

Financial Outlook

Santhera’s financial performance for the first half of 2024 showed a revenue increase but still operated at a loss. The company had cash and cash equivalents of CHF 16.5 million as of June 30, 2024, bolstered by additional financing of up to CHF 69 million, which is expected to provide funding into 2026[5].

• Operating expenses rose due to increased activities to support AGAMREE’s commercialization, and development expenses increased by 40% due to additional long-term studies and development activities[5].

Key Takeaways

• FDA Approval: AGAMREE received FDA approval for the treatment of DMD in October 2023.
• Commercialization: Launched in the U.S. by Catalyst Pharmaceuticals in March 2024.
• Licensing Agreements: Exclusive agreements with Catalyst for North America and Sperogenix for China.
• Market Demand: Strong demand with favorable payer landscape, leading to increased revenue guidance.
• Financial Performance: Significant revenue boost for Santhera from licensing agreements; Catalyst reports robust Q3 results driven by AGAMREE and FIRDAPSE sales.
• Clinical Activities: Ongoing studies to further investigate AGAMREE’s safety and efficacy.
• Financial Outlook: Santhera expects to break even on a cash basis by the first half of 2026, supported by additional financing.

FAQs

What is AGAMREE (vamorolone), and what is it used for?

AGAMREE (vamorolone) is a novel drug approved for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older.

Who are the key partners involved in the commercialization of AGAMREE?

Santhera Pharmaceuticals has partnered with Catalyst Pharmaceuticals for the commercialization of AGAMREE in North America and with Sperogenix Therapeutics for China.

What are the financial projections for AGAMREE in 2024?

Catalyst Pharmaceuticals has updated its full-year 2024 revenue guidance for AGAMREE to $40 million to $45 million, driven by strong demand and a favorable payer landscape.

What clinical studies are currently underway for AGAMREE?

Santhera is conducting studies to investigate AGAMREE’s safety and efficacy in a broader patient age group, a Phase 1 study in healthy volunteers, and a Phase 2 pilot study in Becker muscular dystrophy (BMD).

When does Santhera expect to break even on a cash basis?

Santhera expects to break even on a cash basis by the first half of 2026, supported by additional financing and revenue from AGAMREE sales.

Sources

1. Santhera Pharmaceuticals. (2023, October 27). Santhera Receives U.S. FDA Approval of AGAMREE® (vamorolone) for the Treatment of Duchenne Muscular Dystrophy (DMD). Retrieved from https://www.santhera.com/assets/files/press-releases/2023-10-27_FDA-approval_e_final.pdf
2. Santhera Pharmaceuticals. (2023). Santhera Annual Report 2023. Retrieved from https://www.santhera.com/assets/files/financial_reports/2023_SANN_AnnualReport2023_final.pdf
3. Investing.com. (2024, November 7). Earnings call: Catalyst Pharma reports robust Q3 results, raises guidance. Retrieved from https://www.investing.com/news/transcripts/earnings-call-catalyst-pharma-reports-robust-q3-results-raises-guidance-93CH-3709582
4. BioSpace. (2024, March 14). Santhera's Partner Catalyst Pharmaceuticals Launches AGAMREE (vamorolone) in the United States. Retrieved from https://www.biospace.com/santhera-s-partner-catalyst-pharmaceuticals-launches-agamree-vamorolone-in-the-united-states
5. Synapse by PatSnap. (2024, September 14). Santhera Reports H1 2024 Financials and Corporate Update. Retrieved from https://synapse.patsnap.com/article/santhera-reports-h1-2024-financials-and-corporate-update