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ADASUVE Drug Patent Profile

Which patents cover Adasuve, and what generic alternatives are available?

Adasuve is a drug marketed by Alexza Pharms and is included in one NDA. There are five patents protecting this drug.

This drug has two hundred and twenty-seven patent family members in twenty-one countries.

The generic ingredient in ADASUVE is loxapine. There are eight drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the loxapine profile page.

DrugPatentWatch^® Generic Entry Outlook for Adasuve

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for ADASUVE

International Patents:	227
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	51
Clinical Trials:	13
Patent Applications:	5,040
Drug Prices:	Drug price information for ADASUVE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ADASUVE
What excipients (inactive ingredients) are in ADASUVE?	ADASUVE excipients list
DailyMed Link:	ADASUVE at DailyMed

See drug prices for ADASUVE

Recent Clinical Trials for ADASUVE

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

Sponsor	Phase
Lee's Pharmaceutical Limited	Phase 3
University of Arkansas	Phase 4
Mount Sinai Hospital, Chicago	Phase 4

See all ADASUVE clinical trials

US Patents and Regulatory Information for ADASUVE

ADASUVE is protected by five US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alexza Pharms	ADASUVE	loxapine	POWDER;INHALATION	022549-001	Dec 21, 2012		RX	Yes	Yes	8,991,387		Y
Alexza Pharms	ADASUVE	loxapine	POWDER;INHALATION	022549-001	Dec 21, 2012		RX	Yes	Yes	7,458,374		Y
Alexza Pharms	ADASUVE	loxapine	POWDER;INHALATION	022549-001	Dec 21, 2012		RX	Yes	Yes	9,370,629		Y
Alexza Pharms	ADASUVE	loxapine	POWDER;INHALATION	022549-001	Dec 21, 2012		RX	Yes	Yes	8,387,612		Y
Alexza Pharms	ADASUVE	loxapine	POWDER;INHALATION	022549-001	Dec 21, 2012		RX	Yes	Yes	7,537,009		Y

Expired US Patents for ADASUVE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Alexza Pharms	ADASUVE	loxapine	POWDER;INHALATION	022549-001	Dec 21, 2012	7,585,493
Alexza Pharms	ADASUVE	loxapine	POWDER;INHALATION	022549-001	Dec 21, 2012	9,440,034
Alexza Pharms	ADASUVE	loxapine	POWDER;INHALATION	022549-001	Dec 21, 2012	6,716,416
Alexza Pharms	ADASUVE	loxapine	POWDER;INHALATION	022549-001	Dec 21, 2012	8,235,037
Alexza Pharms	ADASUVE	loxapine	POWDER;INHALATION	022549-001	Dec 21, 2012	8,173,107

EU/EMA Drug Approvals for ADASUVE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Ferrer Internacional S.A.	Adasuve	loxapine	EMEA/H/C/002400 Adasuve is indicated for the rapid control of mild-to-moderate agitation in adult patients with schizophrenia or bipolar disorder. Patients should receive regular treatment immediately after control of acute agitation symptoms.	Authorised	no	no	no	2013-02-20

International Patents for ADASUVE

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	02094219
Spain	2324023
European Patent Office	1392258	ADMINISTRATION PAR VOIE PULMONAIRE D'ALPRAZOLAM, D'ESTAZOLAM, DE MIDAZOLAM OU DE TRIAZOLAM (DELIVERY OF ALPRAZOLAM, ESTAZOLAM, MIDAZOLAM OR TRIAZOLAM THROUGH AN INHALATION ROUTE)
Austria	425746
Canada	2447210	ADMINISTRATION D'AEROSOLS CONTENANT DE PETITES PARTICULES VIA UNE VOIE D'INHALATION (DELIVERY OF AEROSOLS CONTAINING SMALL PARTICLES THROUGH AN INHALATION ROUTE)

Supplementary Protection Certificates for ADASUVE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1389098	132013902184784	Italy		PRODUCT NAME: LOXAPINA(ADASUVE); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/823/001-002, 20130220
1389098	1390040-2	Sweden		PRODUCT NAME: LOXAPIN; REG. NO/DATE: EU/1/13/823/001 20130220
1389098	SPC/GB13/055	United Kingdom		PRODUCT NAME: LOXAPINE; REGISTERED: UK EU/1/13/823/001 20130220; UK EU/1/13/823/002 20130220
1389098	C300609	Netherlands		PRODUCT NAME: LOXAPINE; REGISTRATION NO/DATE: EU/1/13/823/001-002 20130220
1389098	C01389098/01	Switzerland		PRODUCT NAME: LOXAPINUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65461 13.12.2016

ADASUVE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ADASUVE

Introduction

ADASUVE, developed by Alexza Pharmaceuticals, is an innovative inhalation powder of loxapine designed to treat acute agitation in adults with schizophrenia or bipolar I disorder. This article delves into the market dynamics and financial trajectory of ADASUVE, highlighting its commercial prospects, challenges, and the impact on Alexza Pharmaceuticals.

Commercial Prospects of ADASUVE

Approval and Launch

ADASUVE received FDA and EU approval for the acute treatment of agitation in adults with schizophrenia or bipolar I disorder. The drug was launched in Germany by Ferrer and was expected to be launched in the US by Teva in Q1 2014[1].

Market Positioning

ADASUVE offers significant advantages over traditional oral medications, including rapid onset of action and ease of administration. These benefits are crucial in medical emergency settings, where quick and reliable treatment is essential. The drug demonstrated a statistically significant decrease in agitation within 10 minutes of dosing, with sustained improvement over 2 hours[4].

Pricing Strategy

Despite a premium price of $75-100 per dose, compared to less than $10 for most oral drugs, the rapid effect and dosing convenience of ADASUVE were expected to drive product uptake. The pricing strategy was based on the drug's unique benefits and the potential to reduce overall treatment costs by minimizing the need for repeated dosing and reducing the time spent in emergency settings[1].

Financial Performance

Revenue Projections

Initial projections suggested that ADASUVE could achieve global sales of over $200 million by 2018, with a peak market share of 20%[1]. By 2022, peak global revenue was estimated to reach $230 million, with sustained profitability anticipated from 2016[1].

Quarterly Financial Results

In the first quarter of 2016, Alexza reported revenues of $0.7 million, primarily from product sales to Teva and Ferrer, as well as royalty revenues. This was consistent with the previous year's figures. However, the company's net loss increased to $3.4 million from $0.4 million in the same period in 2015, largely due to changes in the contingent liability fair value model and the suspension of commercial ADASUVE production operations in 2015[2].

Cost Structure

Research and development expenses decreased by $1.4 million in the first quarter of 2016 compared to the same period in 2015, mainly due to the company's restructuring strategy and reduction in employee headcount. General and administrative expenses also saw a decline from $3.7 million to $2.4 million during the same period[2].

Challenges and Setbacks

Respiratory Concerns

Although ADASUVE demonstrated minimal respiratory toxicity risk, the FDA required a REMS (Risk Evaluation and Mitigation Strategy) protocol due to higher respiratory events in patients with active airway disease. This could potentially deter some physicians and facilities from using the drug, although the risk was considered minimal[1].

Partnership and Production Issues

Alexza Pharmaceuticals faced significant challenges when its partnership with Teva ended in 2015. The company announced plans to reacquire the rights to ADASUVE, which led to the suspension of commercial production operations. This decision had a substantial impact on the company's financial performance and market trajectory[5].

Valuation and Investment Case

Net Present Value (NPV) Calculation

The net present value (NPV) for ADASUVE and another product candidate, AZ-002 (Staccato alprazolam), was estimated at $85 million. Adding $32 million in net cash, this resulted in a valuation of $6.77 per share for Alexza Pharmaceuticals, indicating significant upside potential compared to the then-current share price of $4.32[1].

Staccato Platform Technology

The Staccato inhalation delivery platform, underlying ADASUVE, was seen as a valuable asset with potential applications in other pharmaceutical ingredients. This technology presented additional value-creation opportunities, although it was not specifically valued in the initial assessment[1].

Future Development and Pipeline

AZ-002 and Other Candidates

In addition to ADASUVE, Alexza was advancing AZ-002 as a treatment candidate for acute repetitive seizures in epilepsy patients. A Phase II study was expected to start in the second half of 2013, with further development candidates potentially announced in the first half of 2014[1].

Key Takeaways

• Rapid Onset and Convenience: ADASUVE's quick effect and ease of administration positioned it as a key agent for treating acute agitation.
• Financial Performance: Despite initial revenue projections, the company faced financial challenges, including increased net losses and the suspension of commercial production.
• Challenges: Respiratory concerns and the end of the partnership with Teva were significant setbacks.
• Valuation: The NPV calculation indicated upside potential, and the Staccato platform technology offered additional value-creation opportunities.
• Future Development: Alexza continued to develop other products using the Staccato platform, including AZ-002.

FAQs

What is ADASUVE used for?

ADASUVE is used for the acute treatment of agitation in adults with schizophrenia or bipolar I disorder.

What are the key benefits of ADASUVE?

ADASUVE offers a rapid onset of action and ease of administration, making it a valuable option in medical emergency settings.

Why did Alexza Pharmaceuticals suspend commercial production of ADASUVE?

Commercial production was suspended due to the end of the partnership with Teva and the subsequent reacquisition of rights by Alexza Pharmaceuticals.

What is the Staccato platform technology?

The Staccato platform is a proprietary inhalation delivery system developed by Alexza Pharmaceuticals, which provides rapid and efficient drug delivery.

How did the financial performance of Alexza Pharmaceuticals change after the launch of ADASUVE?

The company reported increased net losses and a decline in research and development expenses following the suspension of commercial production and the end of the partnership with Teva.

Sources

1. Edison Investment Research: "Alexza Pharmaceuticals - Edison Investment Research" (August 27, 2013)
2. PR Newswire: "Alexza Reports 2016 First Quarter Financial Results" (May 11, 2016)
3. PR Newswire: "Trevi Therapeutics Announces Appointment of James V. Cassella, Ph.D., as Chief Development Officer" (September 30, 2024)
4. ADASUVE Formulary Kit Monograph: "ADA-50102 with current PI inserted v5.indd - ADASUVE"
5. BioSpace: "Alexza Pharma and Teva Break Up Over Adasuve" (November 2, 2015)