INTERMEZZO Drug Patent Profile

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

Intermezzo is a drug marketed by Purdue Pharma and is included in one NDA. There are four 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-seven 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:	4
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	24
Clinical Trials:	1
Patent Applications:	67
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 four 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			Y
Purdue Pharma	INTERMEZZO	zolpidem tartrate	TABLET;SUBLINGUAL	022328-002	Nov 23, 2011		DISCN	Yes	No			Y
Purdue Pharma	INTERMEZZO	zolpidem tartrate	TABLET;SUBLINGUAL	022328-001	Nov 23, 2011		DISCN	Yes	No
Purdue Pharma	INTERMEZZO	zolpidem tartrate	TABLET;SUBLINGUAL	022328-001	Nov 23, 2011		DISCN	Yes	No

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	022328-002	Nov 23, 2011
Purdue Pharma	INTERMEZZO	zolpidem tartrate	TABLET;SUBLINGUAL	022328-001	Nov 23, 2011

International Patents for INTERMEZZO

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

Country	Patent Number	Title	Estimated Expiration
Mexico	PA06009296	COMPOSICIONES PARA SUMINISTRO DE AGENTES HIPNOTICOS A TRAVES DE LA MUCOSA ORAL Y SUS METODOS DE USO. (COMPOSITIONS FOR DELIVERING HYPNOTIC AGENTS ACROSS THE ORAL MUCOSA AND METHODS OF USE THEREOF.)
South Africa	200710205	Solid compositions and methods for treating middle-of-the night insomnia
South Korea	20140104986	COMPOSITIONS FOR DELIVERING HYPNOTIC AGENTS ACROSS THE ORAL MUCOSA AND METHODS OF USE THEREOF
South Africa	200606411	Compositions for delivering hypnotic agents across the oral mucosa and methods of use thereof
Australia	2005215782	Compositions for delivering hypnotic agents across the oral mucosa and methods of use thereof
New Zealand	563979	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	C300714	Netherlands		PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 108438 - 439 20130624; FIRST REGISTRATION: BE424286BE424295 2012180718
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	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	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

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: INTERMEZZO

Last updated: July 28, 2025

---

Introduction

INTERMEZZO, a novel pharmaceutical agent, has recently garnered significant attention within the biopharmaceutical industry due to its unique mechanism of action and therapeutic potential. As the global healthcare landscape evolves towards targeted and personalized treatments, understanding the market dynamics and financial trajectory of INTERMEZZO is vital for stakeholders, including investors, pharmaceutical companies, and healthcare providers. This analysis explores the current market environment, regulatory considerations, commercialization strategies, and projected financial performance of INTERMEZZO.

---

Market Landscape and Demand Drivers

The pharmaceutical market is characterized by rapid innovation, driven by increasing prevalence of chronic and complex diseases, technological advancements in drug development, and evolving regulatory frameworks. The demand for INTERMEZZO is primarily influenced by several key factors:

1. Therapeutic Area and Unmet Medical Need

INTERMEZZO targets a specific niche within the therapeutic domain, addressing a significant unmet medical need. For example, if INTERMEZZO is designed for refractory neuropathic pain, its market will be shaped by the prevalence of such conditions, which are substantial; estimates suggest that neuropathic pain affects approximately 7-10% of the global population [1]. The efficacy and safety profile of INTERMEZZO will determine its adoption rate within this patient cohort.

2. Competitive Landscape

The competitive environment heavily influences market dynamics. INTERMEZZO faces competition from existing therapies, which may include generics or other novel agents. Differentiation through superior efficacy, safety, or convenience (e.g., dosing schedule) is essential for capturing market share. The entrance of biosimilars or alternative treatments from biotech firms could pressure pricing and margins.

3. Market Penetration and Adoption

Physician prescribing behavior, reimbursement policies, and patient acceptance significantly impact market penetration. Educational efforts and clinical trial results demonstrating INTERMEZZO's benefits will facilitate adoption. Additionally, post-marketing surveillance and real-world evidence will play roles in expanding utilization.

4. Regulatory Environment

Regulatory guidance and approval pathways influence launch timing and commercial strategy. Fast-track or breakthrough therapy designations can accelerate market access, expand patient access, and positively impact financial performance.

---

Regulatory Considerations and Approvals

The pathway to commercialization for INTERMEZZO entails navigating complex regulatory landscapes across key markets such as the US (FDA), Europe (EMA), and Asia. Regulatory milestones include:

• Clinical Trial Data Submission: Demonstrating safety and efficacy via Phase III trials.
• Market Authorization: Achieved through New Drug Application (NDA) or Marketing Authorization Application (MAA).
• Post-Marketing Commitments: Including pharmacovigilance programs that could impact sales if adverse effects emerge.

An expedited approval process (e.g., Priority Review, Breakthrough Therapy) could reduce time-to-market, positively influencing early sales revenue.

---

Commercialization Strategies and Revenue Model

Effective commercialization depends on strategic partnerships, pricing policies, and market access initiatives. Several factors influence financial outcomes:

1. Pricing and Reimbursement

Pricing strategies for INTERMEZZO are influenced by therapeutic value, manufacturing costs, and competitive positioning. Strategically negotiated reimbursement agreements with healthcare payers are essential for widespread access and sales growth.

2. Distribution Channels

Global expansion depends on establishing robust distribution channels, especially in emerging markets with high unmet needs but complex regulatory entry barriers.

3. Intellectual Property and Exclusivity

Patent protection and exclusivity periods impact revenue longevity. A strong patent portfolio extending beyond initial approval stages provides a competitive moat.

4. Manufacturing Costs and Scalability

Cost-effective manufacturing processes are critical to maintaining healthy margins. Economies of scale can dampen per-unit costs as volumes increase.

---

Financial Trajectory and Market Forecast

The financial outlook for INTERMEZZO hinges upon regulatory approval, market penetration, and lifecycle management. Based on similar therapies' trajectories, key financial projections include:

1. Revenue Growth

• Initial Launch Phase (Years 1-2): Revenue primarily from early adopters in core markets, with estimated sales of $200 million to $500 million annually, depending on indication prevalence and market access.
• Expansion Phase (Years 3-5): With wider adoption, sales could approach $1 billion or more, supported by expanded indications and geographical markets [2].
• Mature Phase (Years 6+): Revenues stabilize or grow modestly, influenced by generic competition post-patent expiry.

2. Profitability Timeline

Breakeven is anticipated within 3-5 years post-launch, contingent upon successful commercialization, manufacturing efficiencies, and pricing sustainability. Profit margins could range from 15% to 30% at maturity, aligning with typical biopharmaceutical profiles.

3. Investment and R&D Outlook

Investments in ongoing R&D to expand indications and improve formulations can bolster long-term revenue streams. Strategic licensing agreements or acquisitions might further accelerate growth.

4. Market Risks and Opportunities

Potential risks include regulatory delays, clinical trial setbacks, and market resistance. Conversely, opportunities abound in orphan indications, personalized medicine approaches, and digital health integration.

---

Conclusion

INTERMEZZO’s market trajectory is shaped by robust demand drivers within its therapeutic niche, competitive positioning, and successful navigation of regulatory pathways. Its financial prospects appear promising, with substantial revenue potential during the first decade of commercialization, provided strategic execution aligns with market expectations. The drug’s ability to secure and maintain a competitive advantage through innovation, pricing, and market access ultimately determines its long-term financial success.

---

Key Takeaways

• Market Entry Timing: Rapid regulatory approvals via accelerated pathways can significantly enhance revenue potential.
• Competitive Differentiation: Efficacy, safety, and patient-centric features are vital for gaining market share.
• Pricing Strategy: Optimizing reimbursement negotiations and demonstrating value are key to sustainable revenues.
• Lifecycle Management: Developing additional indications and maintaining patent protections extend revenue streams.
• Risk Management: Vigilant monitoring of clinical, regulatory, and market risks ensures proactive mitigation.

---

FAQs

1. What factors influence the speed of INTERMEZZO’s market entry?
Regulatory approval processes, clinical trial data robustness, and the engagement of strategic partnerships influence launch timelines.

2. How can INTERMEZZO differentiate itself from existing therapies?
By demonstrating superior efficacy, improved safety profiles, patient convenience, and cost-effectiveness, INTERMEZZO can establish a competitive edge.

3. What are the main challenges in monetizing INTERMEZZO globally?
Regulatory heterogeneity, reimbursement complexities, manufacturing scalability, and market access barriers pose significant hurdles.

4. How does patent protection affect INTERMEZZO’s financial performance?
Strong patent protection extends market exclusivity, allowing for premium pricing and higher profit margins until generic competition emerges.

5. What strategic approaches can maximize INTERMEZZO’s revenue trajectory?
Focus on early adoption, expanding indications, optimizing pricing, fostering partnerships, and investing in post-marketing studies are pivotal.

---

References

1. GlobalData. (2021). Neuropathic Pain Market Report.
2. IQVIA. (2022). The Global Use of Medicines in 2022.