IGALMI Drug Patent Profile

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

Igalmi is a drug marketed by Bioxcel and is included in one NDA. There are twelve patents protecting this drug.

This drug has sixty-seven patent family members in sixteen countries.

The generic ingredient in IGALMI is dexmedetomidine hydrochloride. There are fourteen drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the dexmedetomidine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Igalmi

A generic version of IGALMI was approved as dexmedetomidine hydrochloride by ENDO OPERATIONS on August 18^th, 2014.

Summary for IGALMI

International Patents:	67
US Patents:	12
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	100
Clinical Trials:	3
Patent Applications:	242
Drug Prices:	Drug price information for IGALMI
What excipients (inactive ingredients) are in IGALMI?	IGALMI excipients list
DailyMed Link:	IGALMI at DailyMed

See drug prices for IGALMI

Recent Clinical Trials for IGALMI

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

Sponsor	Phase
NYU Langone Health	Phase 2
BioXcel Therapeutics Inc	Phase 4
Lotus Clinical Research, LLC	Phase 4

See all IGALMI clinical trials

Pharmacology for IGALMI

Drug Class	Central alpha-2 Adrenergic Agonist
Mechanism of Action	Adrenergic alpha2-Agonists
Physiological Effect	General Anesthesia

US Patents and Regulatory Information for IGALMI

IGALMI is protected by thirteen US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bioxcel	IGALMI	dexmedetomidine hydrochloride	FILM;BUCCAL, SUBLINGUAL	215390-002	Apr 5, 2022		RX	Yes	Yes
Bioxcel	IGALMI	dexmedetomidine hydrochloride	FILM;BUCCAL, SUBLINGUAL	215390-001	Apr 5, 2022		RX	Yes	Yes
Bioxcel	IGALMI	dexmedetomidine hydrochloride	FILM;BUCCAL, SUBLINGUAL	215390-002	Apr 5, 2022		RX	Yes	Yes
Bioxcel	IGALMI	dexmedetomidine hydrochloride	FILM;BUCCAL, SUBLINGUAL	215390-002	Apr 5, 2022		RX	Yes	Yes

International Patents for IGALMI

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

Country	Patent Number	Title	Estimated Expiration
China	114375191
Mexico	2022010274	USO DE DEXMEDETOMIDINA SUBLINGUAL PARA EL TRATAMIENTO DE LA AGITACION. (USE OF SUBLINGUAL DEXMEDETOMIDINE FOR THE TREATMENT OF AGITATION.)
Taiwan	I791479
Finland	3562486

Supplementary Protection Certificates for IGALMI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0300652	C300117	Netherlands		PRODUCT NAME: DEXMEDETOMIDINE, DESGEWENST IN DE VORM VAN EEN NIET-TOXISCH IN FARMACEUTISCH OPZICHT AANVAARDBAAR ZUURADDITIEZOUT, IN HET BIJZ ONDER DEXMEDETOMIDINE HYDROCHLORIDE; REGISTRATION NO/DATE: EU/2/02/033/001 20020830
0300652	2003C/005	Belgium		PRODUCT NAME: CHLORHYDRATE DE DEXMEDETOMIDINE; REGISTRATION NO/DATE: EU/2/02/033/001 20020903

IGALMI Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for IGALMI (Dexmedetomidine Sublingual Film)

Introduction to IGALMI

IGALMI, developed by BioXcel Therapeutics, is a dexmedetomidine sublingual film approved for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder. This innovative medication has been making significant strides in the market, driven by its unique formulation and targeted market-access strategies.

Market Indication and Target Population

IGALMI is specifically indicated for the treatment of agitation in institutional settings, where an estimated 16 million agitation episodes occur annually. The company is also exploring expansion into the at-home setting, which could potentially address an additional 23 million annual agitation episodes[1].

Revenue Growth and Financial Performance

Quarterly Revenue

As of the second quarter of 2024, BioXcel Therapeutics reported preliminary estimated unaudited net revenue of approximately $1.1 million from IGALMI sales. This represents a 90% increase from the prior quarter and a 141% increase from the same period in 2023. This significant growth is attributed to increased contracting with psychiatric care clinics and behavioral health facilities[1].

Historical Revenue Context

In the third quarter of 2023, the net revenue from IGALMI was approximately $341,000, which was a notable increase from the $137,000 reported in the same period of 2022. This growth trend indicates a steady expansion of IGALMI's market presence[2][5].

Commercialization Strategy

BioXcel Therapeutics has implemented a focused market-access strategy that includes building brand awareness and contracting with key healthcare providers. This approach has been instrumental in driving the revenue growth of IGALMI. The company has also secured a permanent J-Code from the Centers for Medicare & Medicaid Services, which is expected to streamline the reimbursement process across commercial and government payers[5].

Clinical Trials and Regulatory Updates

Post-Marketing Requirement (PMR) Study

A recent PMR study demonstrated no evidence of tachyphylaxis, tolerance, or withdrawal with the 180 mcg dose of IGALMI after seven days of as-needed treatment. This study supports the ongoing Phase 3 SERENITY and TRANQUILITY programs and may lead to potential changes in the label language[4].

Phase 3 Trials

BioXcel Therapeutics has aligned with FDA recommendations for a Phase 3 trial to evaluate the safety of IGALMI in the at-home setting using the 120 mcg approved dose. This trial is crucial for expanding IGALMI's indication into the at-home market[5].

Safety and Tolerability

The PMR study and pharmacovigilance monitoring have shown that IGALMI is generally well-tolerated with favorable safety results. Over 10,000 treatments have been administered since its launch, with no new or unexpected safety events reported in clinical settings[4][5].

Research and Development Expenses

While IGALMI's revenue is growing, BioXcel Therapeutics continues to invest heavily in research and development. In the third quarter of 2023, R&D expenses were $19.6 million, slightly lower than the $22.1 million in the same period of 2022, primarily due to decreased expenses associated with the SERENITY III and TRANQUILITY II clinical trials[2][5].

Selling, General, and Administrative Expenses

SG&A expenses have increased, primarily due to one-time legal and professional fees, costs associated with the potential public offering of OnkosXcel Therapeutics, and personnel costs to support IGALMI's commercialization. In the third quarter of 2023, SG&A expenses were $24.3 million, up from $17.1 million in the same period of 2022[2][5].

Strategic Financing

BioXcel Therapeutics has secured revised strategic financing agreements with Oaktree Capital Management and the Qatar Investment Authority. These revised terms are expected to enhance the company's operational and financial flexibility by increasing access to additional capital and adjusting revenue covenants to reflect current projections[5].

Patent Protection and Intellectual Property

The company has extended its patent protection for IGALMI up to 2043 with two new Orange Book-listed U.S. patents related to the method of use of sublingual dexmedetomidine for treating agitation associated with bipolar disorders and schizophrenia[5].

Future Outlook and Expansion Plans

BioXcel Therapeutics is focused on advancing its SERENITY and TRANQUILITY programs to address both the in-care and at-home markets. The positive feedback from physicians, caregivers, and patients, along with the successful clinical trial results, positions IGALMI for continued growth and potential expansion into new indications, such as agitation associated with Alzheimer’s dementia[1][4].

Key Takeaways

• Revenue Growth: IGALMI has shown significant revenue growth, with a 90% increase in the second quarter of 2024 compared to the prior quarter.
• Commercial Strategy: Focused market-access strategies have driven this growth, including contracting with psychiatric care clinics and behavioral health facilities.
• Clinical Trials: Positive results from PMR studies and ongoing Phase 3 trials support the expansion of IGALMI into the at-home setting.
• Safety and Tolerability: IGALMI has demonstrated favorable safety results with no new or unexpected safety events reported.
• Financial Flexibility: Revised strategic financing agreements enhance the company's operational and financial flexibility.

Frequently Asked Questions (FAQs)

What is IGALMI used for?

IGALMI is used for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder.

How has IGALMI's revenue performed recently?

IGALMI's revenue has shown significant growth, with a 90% increase in the second quarter of 2024 compared to the prior quarter, reaching approximately $1.1 million.

What are the key findings from the recent PMR study on IGALMI?

The PMR study demonstrated no evidence of tachyphylaxis, tolerance, or withdrawal with the 180 mcg dose of IGALMI after seven days of as-needed treatment, supporting its safety and efficacy.

What are BioXcel Therapeutics' plans for expanding IGALMI's indication?

The company is planning to conduct Phase 3 trials to evaluate the safety of IGALMI in the at-home setting and is also advancing its SERENITY and TRANQUILITY programs to address agitation associated with dementia in patients with probable Alzheimer’s disease.

How has BioXcel Therapeutics managed its financing to support IGALMI's commercialization?

The company has secured revised strategic financing agreements to enhance its operational and financial flexibility, including increased access to additional capital and adjusted revenue covenants.

Cited Sources:

1. BioXcel Therapeutics Announces Preliminary Estimated Unaudited Second Quarter Net Revenues from Sales of IGALMI™ (dexmedetomidine) Sublingual Film. GlobeNewswire, July 16, 2024.
2. BioXcel Therapeutics Aligns with FDA Recommendation for Phase 3 Trial for TRANQUILITY Program, Provides Update on Strategic Financing and Reports Third Quarter 2023 Financial Results. BioSpace, November 14, 2023.
3. Form 10-Q for Bioxcel Therapeutics INC filed 05/09/2024. BioXcel Therapeutics, May 7, 2024.
4. BioXcel Therapeutics Announces Positive Topline Results from Post-Marketing Requirement Study Evaluating PRN Treatment of IGALMI™ (dexmedetomidine) Sublingual Film for Agitation Associated with Bipolar Disorders or Schizophrenia. GlobeNewswire, June 25, 2024.
5. BioXcel Therapeutics Aligns with FDA Recommendation for Phase 3 Trial for TRANQUILITY Program, Provides Update on Strategic Financing and Reports Third Quarter 2023 Financial Results. GlobeNewswire, November 14, 2023.