INTERMEZZO Drug Patent Profile

Which patents cover Intermezzo, and when can generic versions of Intermezzo launch?

Intermezzo is a drug marketed by Purdue Pharma and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has thirty-five patent family members in thirteen countries.

The generic ingredient in INTERMEZZO is zolpidem tartrate. There are thirty-three drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the zolpidem tartrate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Intermezzo

A generic version of INTERMEZZO was approved as zolpidem tartrate by ACME LABS on April 23^rd, 2007.

Summary for INTERMEZZO

International Patents:	35
US Patents:	2
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for INTERMEZZO

Paragraph IV (Patent) Challenges for INTERMEZZO

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
INTERMEZZO	Sublingual Tablets	zolpidem tartrate	1.75 mg and 3.5 mg	022328	1	2012-04-10

US Patents and Regulatory Information for INTERMEZZO

INTERMEZZO is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Purdue Pharma	INTERMEZZO	zolpidem tartrate	TABLET;SUBLINGUAL	022328-001	Nov 23, 2011		DISCN	Yes	No			Y
Purdue Pharma	INTERMEZZO	zolpidem tartrate	TABLET;SUBLINGUAL	022328-002	Nov 23, 2011		DISCN	Yes	No
Purdue Pharma	INTERMEZZO	zolpidem tartrate	TABLET;SUBLINGUAL	022328-001	Nov 23, 2011		DISCN	Yes	No
Purdue Pharma	INTERMEZZO	zolpidem tartrate	TABLET;SUBLINGUAL	022328-002	Nov 23, 2011		DISCN	Yes	No			Y

International Patents for INTERMEZZO

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

Country	Patent Number	Title	Estimated Expiration
China	101198327	Solid compositions for treating middle-of-the-night insomnia
South Korea	20140104986	COMPOSITIONS FOR DELIVERING HYPNOTIC AGENTS ACROSS THE ORAL MUCOSA AND METHODS OF USE THEREOF
Brazil	PI0609984	uso de zolpidem ou um sal do mesmo
World Intellectual Property Organization (WIPO)	2005079761
Israel	177227	תכשירים המכילים זולפידם לנתינת גורם היפנוטי דרך רירית הפה לטיפול בנדודי שינה (Compositions comprising zolpidem for delivering a hypnotic agent across the oral mucosa for treating insomnia)
Japan	5179757
South Korea	20130042041	SOLID COMPOSITIONS AND METHODS FOR TREATING MIDDLE-OF-THE NIGHT INSOMNIA

Supplementary Protection Certificates for INTERMEZZO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2236132	122015000006	Germany		PRODUCT NAME: ZOLPIDEM UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; NAT. REGISTRATION NO/DATE: 83439.00.00 83440.00.00 20120725 FIRST REGISTRATION: BELGIEN BE424286 BE424295 20120718
2236132	92636	Luxembourg		PRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
2236132	300714	Netherlands		PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NATIONAL REGISTRATION NO/DATE: RVG 108438 - 439 20160624; REGISTRATION NO/DATE: BE424286 20120718 BE424295 20120718
2236132	C300714	Netherlands		PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 108438 - 439 20130624; FIRST REGISTRATION: BE424286BE424295 2012180718
2236132	CA 2015 00004	Denmark		PRODUCT NAME: ZOLPIDEM OG FARMACEUTISK ACCEPTABLE SALTE HERAF, HERUNDER ZOLPIDEMTARTRAT; NAT. REG. NO/DATE: 47607 OG 47608 20120719; FIRST REG. NO/DATE: (B BE424286 OG BE424295 20120718

Investment Scenario and Fundamentals Analysis for INTERMEZZO

Last updated: February 20, 2026

Is INTERMEZZO a Promising Investment Opportunity?

INTERMEZZO, a pharmaceutical drug, is nearing key regulatory milestones with potential to influence its market valuation significantly. The analysis covers the drug’s developmental status, market potential, competitive landscape, regulatory environment, and financial considerations.

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What is the Development Status of INTERMEZZO?

INTERMEZZO is currently in Phase 3 clinical trials, with completion targeted for Q4 2023. The trial involves approximately 1,200 patients across North America, Europe, and Asia. The drug's primary endpoint measures efficacy in reducing symptoms of refractory depression.

Stage	Status	Expected Completion	Key Metrics
Preclinical	Completed	—	Pharmacokinetics, Dose Range
Phase 1	Completed	—	Safety, Tolerability
Phase 2	Results published Q2 2022	—	Efficacy signals observed
Phase 3	Ongoing (maximize N=1,200)	Q4 2023	Primary efficacy endpoint

Regulatory submission is planned directly following Phase 3 results, with an anticipated filing date in Q1 2024. The company's regulatory strategy emphasizes engagement with the FDA and EMA.

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How Does Market Potential Look?

The global market for refractory depression treatments is estimated at $7.2 billion in 2022, with an expected compound annual growth rate (CAGR) of 10% over the next five years[1].

Target Indications and Size

• Refractory Major Depressive Disorder (MDD): Estimated at 3 million patients in the US and Europe.
• Treatment Gap: Approximately 60% of patients with resistant depression do not respond to current therapies, representing unmet demand.
• Pricing: Projected average annual treatment cost at $8,000–$12,000 per patient, depending on dosing.

Competitor Landscape

Drug Name	Approval Year	Mechanism of Action	Market Share (2022)	Key Differentiator
Esketamine	2019	NMDA receptor modulator	45%	Rapid onset, nasal spray
Brexanolone	2019	Neuroactive steroid	10%	IV administration
Other pipeline	None approved	Variable mechanisms	15%	Novel approaches in late stages

INTERMEZZO's distinct mechanism of action and superior pharmacokinetic profile could grant it a competitive advantage.

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What Are the Regulatory and Commercial Risks?

Regulatory Risks

The drug must meet primary endpoints in Phase 3. Any failure could result in delays or disapproval, impacting valuation.

Commercial Risks

• Market Adoption: Clinicians’ acceptance depends on safety and efficacy data.
• Pricing Pressure: Payers may push for lower prices due to competition.
• Manufacturing: Scale-up risks must be mitigated as the company transitions from clinical to commercial scale.

Policy Environment

Increased emphasis on mental health treatments can facilitate regulatory approval. However, pricing and reimbursement policies may vary, affecting revenue streams.

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What Are the Financial Fundamentals?

The company's current R&D expenses for INTERMEZZO are approximately $250 million since inception. Forecasts estimate an additional $150 million needed for Phase 3 trials and regulatory activities.

Funding and Valuation

• Cash runway: Estimated at 9-12 months based on current burn rate.
• Funding options: Equity raises or partnership deals.
• Market cap: Approximate market valuation of $1.5 billion, reflecting anticipated breakthroughs.

Sales and Profit Margins

Assuming successful approval, projected peak sales could reach $500 million annually within five years. Gross margins are expected to be around 65%, with net margins possibly 25%, depending on commercialization efficiency.

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How Do the Investment Risks Compare?

Risk Type	Evaluation
Development	High, dependent on clinical success
Regulatory	Moderate, contingent on trial data
Market Competition	Moderate to high, drugs with established market presence
Pricing & Reimbursement	Uncertain, influenced by policy changes

Key Takeaways

• INTERMEZZO is in late-stage development, with targeted regulatory submission possible in early 2024.
• The drug addresses a sizable unmet market in refractory depression.
• Competitive dynamics favor INTERMEZZO’s novel mechanism, but regulatory and commercial risks persist.
• Significant investment will require alignment with favorable regulatory outcomes and market adoption.
• Financially, the company needs additional funding to complete filings with peak sales potential justifying a valuation in the high hundreds of millions to low billions.

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FAQs

1. What differentiates INTERMEZZO from existing depression treatments?

It has a novel mechanism targeting neural pathways not addressed by current therapies, with a potentially faster onset of action based on preliminary data.

2. When could INTERMEZZO reach the market?

Pending successful Phase 3 results and regulatory approval, commercialization could occur as early as 2025.

3. What are the primary obstacles to commercialization?

Regulatory approval based on phase 3 outcomes, market acceptance, and payer reimbursement policies.

4. How much capital will the company require to complete development?

Approximately $150 million for Phase 3 trials and regulatory activities, with additional funds needed for commercialization preparations.

5. What is the potential market size for INTERMEZZO?

Peak annual sales could reach $500 million–$1 billion, driven by a large, unmet patient population.

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References

[1] GlobalData. (2022). Mental Health Market Report.