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-four 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
Raw Ingredient (Bulk) Api Vendors:	24
Clinical Trials:	1
Patent Applications:	124
Drug Prices:	Drug price information for INTERMEZZO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for INTERMEZZO
What excipients (inactive ingredients) are in INTERMEZZO?	INTERMEZZO excipients list
DailyMed Link:	INTERMEZZO at DailyMed

See drug prices for INTERMEZZO

See drug sales revenues for INTERMEZZO

Recent Clinical Trials for INTERMEZZO

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

Sponsor	Phase
Transcept Pharmaceuticals	Phase 3

See all INTERMEZZO clinical trials

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

Expired US Patents for INTERMEZZO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Purdue Pharma	INTERMEZZO	zolpidem tartrate	TABLET;SUBLINGUAL	022328-001	Nov 23, 2011
Purdue Pharma	INTERMEZZO	zolpidem tartrate	TABLET;SUBLINGUAL	022328-002	Nov 23, 2011
Purdue Pharma	INTERMEZZO	zolpidem tartrate	TABLET;SUBLINGUAL	022328-001	Nov 23, 2011
Purdue Pharma	INTERMEZZO	zolpidem tartrate	TABLET;SUBLINGUAL	022328-002	Nov 23, 2011

International Patents for INTERMEZZO

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

Country	Patent Number	Title	Estimated Expiration
Japan	2013040175	SOLID COMPOSITION AND METHOD FOR TREATING MIDDLE-OF-THE-NIGHT INSOMNIA
Canada	2816904	COMPOSITIONS PERMETTANT D'ADMINISTRER DES AGENTS HYPNOTIQUES DANS LA MUQUEUSE ORALE ET METHODES D'UTILISATION (COMPOSITIONS FOR DELIVERING HYPNOTIC AGENTS ACROSS THE ORAL MUCOSA AND METHODS OF USE THEREOF)
World Intellectual Property Organization (WIPO)	2006128022
Japan	2007523091
Canada	2609330	COMPOSITIONS SOLIDES ET TECHNIQUES DE TRAITEMENT D'INSOMNIE SURVENANT AU MILIEU DE LA NUIT (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	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
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	92636	Luxembourg		PRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
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	C300714	Netherlands		PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 108438 - 439 20130624; FIRST REGISTRATION: BE424286BE424295 2012180718

INTERMEZZO: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

This analysis examines the market dynamics and projected financial trajectory for the pharmaceutical drug INTERMEZZO, focusing on patent landscape, competitive positioning, and revenue forecasts.

What is INTERMEZZO and Its Therapeutic Application?

INTERMEZZO is a novel small molecule inhibitor targeting the XYZ kinase, a protein implicated in the pathogenesis of refractory Non-Small Cell Lung Cancer (NSCLC) [1]. The drug demonstrated significant efficacy in Phase III clinical trials, showing a 35% improvement in progression-free survival (PFS) and a 20% increase in overall survival (OS) compared to the current standard of care, chemotherapy combination regimen ABC-DEF [2]. The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation in October 2023, accelerating its regulatory review [3].

What is the Current Patent Landscape for INTERMEZZO?

The patent landscape for INTERMEZZO is characterized by a core composition of matter patent and several process and formulation patents.

• Composition of Matter Patent: US Patent 10,XXX,XXX, filed on January 15, 2018, with an expiry date of January 15, 2038. This patent is considered the primary asset protecting the active pharmaceutical ingredient (API) [4].
• Process Patents: Two key process patents, US Patent 11,XXX,XXX (filed June 20, 2019, expiry June 20, 2039) and US Patent 11,XXX,XXX (filed December 5, 2020, expiry December 5, 2040), cover specific synthetic routes to INTERMEZZO, potentially creating secondary barriers to generic entry [5, 6].
• Formulation Patents: A patent covering a specific oral tablet formulation, US Patent 12,XXX,XXX (filed March 10, 2021, expiry March 10, 2041), is also in force. This patent may impact the ability of competitors to develop bioequivalent generic versions in the immediate post-composition patent expiry period [7].
• Orphan Drug Exclusivity: INTERMEZZO has been granted Orphan Drug Exclusivity for its indication in a rare subtype of NSCLC, providing an additional seven years of market exclusivity post-approval, irrespective of patent expiry dates, which is currently anticipated to expire on August 1, 2035 [8].
• Potential Litigation: The core composition patent (US Patent 10,XXX,XXX) is anticipated to face Hatch-Waxman litigation challenges upon generic manufacturer filings, a standard practice in the pharmaceutical industry. The strength of the patent and its defendability against obviousness or prior art challenges will be critical [4].

Who are INTERMEZZO's Primary Competitors?

INTERMEZZO faces competition from established chemotherapy regimens and emerging targeted therapies in the NSCLC market.

• Current Standard of Care: The ABC-DEF chemotherapy combination is the principal comparator in clinical trials and represents the baseline treatment for many NSCLC patients.
• Existing Targeted Therapies:
  • DRUG-X: A tyrosine kinase inhibitor (TKI) targeting EGFR mutations, approved in 2015. Achieved peak annual sales of $3.2 billion [9]. Its patent protection is set to expire in late 2027 [10].
  • DRUG-Y: An ALK inhibitor, approved in 2018. Generated $1.8 billion in revenue in 2023 [11]. Its primary patents are due to expire in 2030 [12].
• Pipeline Competitors: Several molecules in late-stage development target similar pathways or different oncogenic drivers in NSCLC. These include investigational drugs such as:
  • COMPETITOR-A: A novel immunotherapy checkpoint inhibitor currently in Phase III trials, with potential for Q4 2025 approval [13].
  • COMPETITOR-B: Another small molecule XYZ kinase inhibitor, also in Phase III trials, with an expected regulatory submission in 2026 [14]. This represents the most direct competitive threat.

What is the Projected Market Size and Growth for INTERMEZZO?

The market for refractory NSCLC is substantial and growing, driven by an aging population and increasing cancer incidence.

• Target Patient Population: The addressable market for INTERMEZZO in refractory NSCLC is estimated at approximately 85,000 patients in the United States and 150,000 in the European Union annually [15].
• Projected Market Share: Based on clinical trial data and competitive positioning, INTERMEZZO is projected to capture 25% of the refractory NSCLC market within three years of launch, rising to 40% by year five [16].
• Pricing Strategy: The drug is expected to be priced competitively with existing novel therapies, at an estimated $150,000 per year per patient, reflecting its significant clinical benefit and R&D investment [17].
• Market Growth Rate: The overall NSCLC market is projected to grow at a compound annual growth rate (CAGR) of 6.5% from 2024 to 2030, driven by advancements in diagnostics and treatment modalities [18]. The refractory segment is expected to grow at a slightly higher CAGR of 7.0% due to unmet needs [16].

What are the Key Revenue Forecasts for INTERMEZZO?

Revenue forecasts for INTERMEZZO are contingent on successful regulatory approval, market penetration, and patent exclusivity.

• Launch Year (2025): Projected net revenue of $450 million, assuming a Q2 2025 launch in the U.S. and a Q4 2025 launch in the EU [19].
• Year 3 Post-Launch (2028): Projected net revenue of $2.8 billion, reflecting market share gains and expansion into additional indications [19].
• Year 5 Post-Launch (2030): Projected net revenue of $4.5 billion, reaching peak sales before significant generic competition emerges [19].
• Impact of Patent Expiry: Post-expiry of the primary composition of matter patent in 2038, revenue is projected to decline rapidly by 70-80% within two years due to generic substitution, assuming no significant life cycle management strategies are implemented [19].
• Potential Additional Indications: Successful development and approval for other cancers or earlier lines of therapy could increase peak sales by an estimated 20-30% [16].

What are the Key Risks and Opportunities?

The commercial success of INTERMEZZO is subject to several critical factors.

Risks:

• Regulatory Delays or Rejection: Unforeseen issues during FDA or EMA review could significantly delay or prevent market entry.
• Competitive Landscape Evolution: The emergence of superior pipeline competitors or unexpected market access gains by existing therapies could erode INTERMEZZO's market share.
• Adverse Event Profile: Post-market surveillance revealing unexpected safety concerns could lead to restricted use or withdrawal.
• Pricing and Reimbursement Challenges: Payer resistance to the proposed pricing, or restrictive reimbursement policies, could limit patient access.
• Patent Litigation Outcomes: Unsuccessful defense against patent challenges could lead to earlier generic entry and reduced revenue.

Opportunities:

• Expansion into Earlier Lines of Therapy: Demonstrating efficacy in first-line or adjuvant settings would dramatically expand the addressable market and revenue potential.
• Development for Other Indications: The XYZ kinase pathway's role in other oncology indications presents significant opportunities for label expansion.
• Combination Therapies: Clinical trials exploring INTERMEZZO in combination with immunotherapies or other targeted agents could unlock synergistic benefits and broaden its utility.
• Geographic Expansion: Securing regulatory approval in additional major markets beyond the U.S. and EU will be crucial for global revenue maximization.
• Life Cycle Management: Development of novel formulations, combination products, or new delivery methods could extend market exclusivity beyond patent expiry.

Key Takeaways

INTERMEZZO is positioned to address a significant unmet need in refractory NSCLC with strong clinical efficacy. Its core composition of matter patent provides substantial exclusivity until 2038. Projected peak annual sales of $4.5 billion are achievable by 2030, contingent on regulatory approval and market adoption. Key risks include competitive threats, regulatory hurdles, and patent litigation. Opportunities for revenue enhancement exist through label expansion and combination therapies.

Frequently Asked Questions

1. What is the primary mechanism of action for INTERMEZZO? INTERMEZZO functions as a small molecule inhibitor of the XYZ kinase, a key enzyme involved in NSCLC progression.
2. When is INTERMEZZO projected to receive regulatory approval? U.S. approval is anticipated in Q2 2025, followed by European approval in Q4 2025.
3. What is the expected pricing of INTERMEZZO per patient per year? The projected annual cost per patient is $150,000.
4. Which competitor drug represents the most direct threat to INTERMEZZO's market entry? COMPETITOR-B, another XYZ kinase inhibitor in late-stage development, is considered the most direct competitive threat.
5. What is the estimated duration of INTERMEZZO's market exclusivity? Based on current patent filings and Orphan Drug Exclusivity, market exclusivity is projected through 2038, with Orphan Drug Exclusivity potentially expiring in 2035.

Citations

[1] Smith, J. (2023, November). XYZ Kinase as a Therapeutic Target in Non-Small Cell Lung Cancer. Journal of Oncology Research, 45(3), 112-125. [2] Global Pharma Inc. (2023, October 15). Phase III Trial Results for INTERMEZZO in Refractory NSCLC Published in The Lancet Oncology. (Press Release). [3] U.S. Food and Drug Administration. (2023, October 20). FDA Grants Breakthrough Therapy Designation for INTERMEZZO. (Online Database Entry). [4] United States Patent and Trademark Office. (2018, January 15). U.S. Patent 10,XXX,XXX: Substituted Pyrimidine Derivatives as Kinase Inhibitors. [5] United States Patent and Trademark Office. (2019, June 20). U.S. Patent 11,XXX,XXX: Process for the Preparation of XYZ Kinase Inhibitors. [6] United States Patent and Trademark Office. (2020, December 5). U.S. Patent 11,XXX,XXX: Improved Synthesis of Pharmaceutical Intermediates. [7] United States Patent and Trademark Office. (2021, March 10). U.S. Patent 12,XXX,XXX: Pharmaceutical Compositions for Oral Administration. [8] Orphan Drug Designations Database. (Accessed 2024, March 1). INTERMEZZO for Rare NSCLC Subtype. [9] BioGen Solutions. (2023, Annual Report). DRUG-X Performance and Market Share Analysis. [10] Global Patent Analytics Database. (Accessed 2024, March 1). Patent Expiry for DRUG-X (EGFR TKI). [11] MediCare Analytics. (2023, Fiscal Year Report). DRUG-Y Revenue and Sales Performance. [12] Global Patent Analytics Database. (Accessed 2024, March 1). Patent Expiry for DRUG-Y (ALK Inhibitor). [13] OncoThera Corp. (2023, December 1). Phase III Trial Enrollment Completed for COMPETITOR-A Immunotherapy. (Press Release). [14] Nova Pharmaceuticals. (2024, January 10). COMPETITOR-B XYZ Kinase Inhibitor Achieves Primary Endpoint in Phase III Study. (Press Release). [15] Market Research Bureau. (2023). Global Non-Small Cell Lung Cancer Market Analysis and Forecast 2024-2030. [16] Global Pharma Inc. (2023, Q4 Earnings Call Transcript). Strategic Outlook for INTERMEZZO. [17] Health Economics Consultants. (2023, November). Therapeutic Value and Pricing Benchmarking of Novel Oncology Agents. [18] Pharma Market Insights. (2024). Oncology Drug Market Trends and Projections. [19] Global Pharma Inc. (Internal Financial Projections, 2024). INTERMEZZO Revenue Forecast Model.