HALCION Drug Patent Profile

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

Halcion is a drug marketed by Pfizer and is included in one NDA.

The generic ingredient in HALCION is triazolam. There are six drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the triazolam profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Halcion

A generic version of HALCION was approved as triazolam by NOVAST LABS on October 20^th, 2020.

Summary for HALCION

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	36
Clinical Trials:	3
Patent Applications:	4,379
Drug Prices:	Drug price information for HALCION
What excipients (inactive ingredients) are in HALCION?	HALCION excipients list
DailyMed Link:	HALCION at DailyMed

See drug prices for HALCION

Recent Clinical Trials for HALCION

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

Sponsor	Phase
Boston Medical Center	Phase 4
Akili Interactive Labs, Inc.	N/A
Pfizer	Phase 1

See all HALCION clinical trials

Pharmacology for HALCION

Drug Class

Benzodiazepine

US Patents and Regulatory Information for HALCION

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	HALCION	triazolam	TABLET;ORAL	017892-003	Apr 26, 1985	AB	RX	Yes	No
Pfizer	HALCION	triazolam	TABLET;ORAL	017892-001	Nov 15, 1982	AB	RX	Yes	Yes
Pfizer	HALCION	triazolam	TABLET;ORAL	017892-002	Nov 15, 1982		DISCN	No	No

Expired US Patents for HALCION

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	HALCION	triazolam	TABLET;ORAL	017892-002	Nov 15, 1982
Pfizer	HALCION	triazolam	TABLET;ORAL	017892-003	Apr 26, 1985
Pfizer	HALCION	triazolam	TABLET;ORAL	017892-002	Nov 15, 1982
Pfizer	HALCION	triazolam	TABLET;ORAL	017892-001	Nov 15, 1982
Pfizer	HALCION	triazolam	TABLET;ORAL	017892-001	Nov 15, 1982

International Patents for HALCION

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

Country	Patent Number	Title	Estimated Expiration
Switzerland	549041	VERFAHREN ZUR HERSTELLUNG VON 6-(O-HALOGENPHENYL)-1-METHYL-4H-S-TRIAZOLO (4,3-A) (1,4-BENZODIAZEPINEN. (Hypnotic pharmaceutical compsns - contg 1-methyl-6 (ortho-chlorophenyl)-5-triazolo (4,3-a) (1,4) benzodiazepine)
France	2128551
Switzerland	548408	VERFAHREN ZUR HERSTELLUNG VON 8-NITRO-6-(O-HALOGENPHENYL)1-METHYL-4H-S-TRIAZOLO(4,3-A)(1,4)-BENZOBENZODIAZEPINEN. (S-triazolo (4,3-a) (1,4) benzodiazepines - as sedatives, hypnotics, tranquillisers, muscle relaxants)
United Kingdom	1291631
Sweden	387641	ANALOGIFORFARANDE FOR FRAMSTELLNING AV S-TRIAXOLO(4,3-A)(1,4)BENSODIAZEPINER

Market Dynamics and Financial Trajectory for HALCION (Triazolam)

Last updated: July 29, 2025

Introduction

HALCION, a brand name for triazolam, is a benzodiazepine primarily prescribed for short-term management of insomnia. Since its development, HALCION has experienced fluctuating market relevance influenced by evolving regulatory standards, shifting prescriber preferences, and emerging safety concerns. This analysis explores the current market landscape, key drivers affecting HALCION’s economic trajectory, and future outlooks within the broader pharmaceutical and sleep management spheres.

Historical Context and Regulatory Environment

Introduced in the 1970s, HALCION gained widespread adoption due to its efficacy in rapid sleep induction. However, increasing concerns over dependence, cognitive impairment, and adverse events led to stricter regulatory controls. The Food and Drug Administration (FDA) classifies triazolam as a controlled substance, Schedule IV, limiting its prescribing and distribution. Consequently, prescriber hesitancy and the advent of alternative treatments, such as non-benzodiazepine hypnotics and cognitive behavioral therapy, diminished HALCION’s market share over the past decade[1].

Current Market Landscape

Market Size and Competition

The global insomnia market was valued at approximately $4.5 billion in 2021 and is projected to grow at a compound annual growth rate (CAGR) of 4-5% through 2027, driven by rising sleep disorder prevalence globally[2]. Despite this growth, HALCION’s share has declined markedly, supplanted by newer agents like zolpidem, eszopiclone, and suvorexant, which are perceived to have better safety profiles.

In terms of market penetration, HALCION remains used in select regions, particularly within niche prescribing settings, but faces intense competition. Generic formulations, introduced after patent expiration in many markets, have reduced pharmaceutical companies’ revenue from HALCION, further impacting its financial trajectory.

Prescriber and Patient Preferences

Physicians increasingly favor non-benzodiazepine hypnotics due to their safety and abuse profiles. Additionally, the shift toward behavioral therapies reduces reliance on pharmacologic treatments. Patient preference leans toward medications with fewer cognitive and dependency risks. Consequently, demand for HALCION notably wanes, especially in developed markets with robust sleep health initiatives.

Innovative and Regulatory Challenges

The safety profile of HALCION continues to impede market expansion. Reports of cognitive impairment, complex sleep behaviors, and withdrawal syndromes exert downward pressure on prescribing rates. Regulatory agencies have issued warnings and recommended cautious use, limiting potential off-label uses and extension into new indications.

In response, pharmaceutical developers have directed efforts towards reformulated or novel agents with improved safety and efficacy profiles. These developments diminish HALCION’s attractiveness from a commercial perspective and are likely to constrain its financial growth prospects.

Financial Trajectory and Future Outlook

Revenue Trends

Historically, HALCION has generated substantial revenues during its peak in the late 20th century. However, revenues have plateaued and declined due to patent expirations and market attrition. Pharmaceutical companies report that HALCION’s sales have been in secular decline over the past decade, with certain markets experiencing a 50-70% reduction in annual sales[3].

Market Penetration and Growth Potential

Short-term growth potential for HALCION is minimal, given regulatory restrictions, safety concerns, and stiff competition. Limited opportunities exist for repositioning or expanding indications without significant reformulation or safety profile improvement initiatives.

Emerging Drivers

1. Generic Market Dynamics: As patent expirations have driven down prices, revenue per unit has decreased, adversely affecting profit margins.
2. Treatment Paradigm Shift: Increasing reliance on behavioral therapy and non-benzodiazepine pharmacotherapies constrains market expansion.
3. Regional Variability: While developed markets show declining usage, some emerging markets exhibit sustained demand due to limited access to newer treatments and differing regulatory landscapes.

Strategic Considerations

Pharmaceutical companies may explore niche applications—for example, in specific patient populations or settings where alternative options are unavailable. However, the overall financial outlook remains subdued unless significant safety profile improvements or repositioning strategies are implemented.

Global Regulatory and Market Trends Impacting HALCION

Current trends favor medications with established safety and minimal dependency potential. International regulatory bodies, including the European Medicines Agency (EMA), tightly monitor benzodiazepine use. The push toward deprescribing and prescription guidelines favoring non-pharmacological interventions increasingly marginalize HALCION’s role[4].

Key Challenges

• Safety concerns limiting new indications and prescriber acceptance.
• Competition from non-benzodiazepine hypnotics with better tolerability.
• Regulatory restrictions curbing off-label and extended use.
• Diminishing revenues due to patent expiry and generics proliferation.

Opportunities and Future Outlook

Innovative formulations or combination therapies with improved safety profiles could potentially revive demand. Nonetheless, the focus on alternative therapies and the accrual of safety-related restrictions suggest a continued decline in HALCION’s market relevance. Companies may phase out marketing and sales efforts in mature markets, concentrating instead on niche segment preservation or exit strategies.

Conclusion

The financial trajectory of HALCION is characterized by a diminishing market share, declining revenues, and limited growth prospects. Market dynamics driven by regulatory restrictions, safety concerns, and shifting prescriber preferences confirm a cautious outlook. Future growth hinges on strategic repositioning, reformulation, or niche targeting, although broad industry trends favor newer, safer sleep therapies with sustained market appeal.

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Key Takeaways

• HALCION’s market dominance has waned due to safety concerns and competition from non-benzodiazepine hypnotics.
• Revenues are declining, with patent expirations facilitating generic competition and price erosion.
• Regulatory restrictions and changing prescribing behaviors further constrain future growth.
• Opportunities for resurgence are limited; success depends on safety-profile enhancements or niche market targeting.
• The broader shift toward non-pharmacologic sleep interventions diminishes long-term prospects for HALCION.

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FAQs

1. Is HALCION still a viable treatment option for insomnia?
While still prescribed in certain regions, HALCION's usage is declining globally due to safety concerns and competition from newer agents. It remains viable in specific contexts but is generally considered a second-line therapy.

2. What are the primary safety issues associated with HALCION?
Risks include cognitive impairment, complex sleep behaviors (e.g., sleepwalking), dependence, withdrawal phenomena, and adverse interactions, prompting regulatory cautions and limiting its use.

3. How has patent expiration affected HALCION’s market share?
Patent expiry has allowed generic formulations, leading to price competition and significantly reduced revenues for branded HALCION.

4. Are there ongoing efforts to reformulate or reposition HALCION?
Currently, there are limited known efforts. Industry focus has shifted toward developing safer, non-benzodiazepine options and non-pharmacological interventions.

5. What is the outlook for the insomnia pharmaceutical market as a whole?
The market is expected to grow steadily, driven by increasing sleep disorder prevalence. However, the demand for benzodiazepine-based treatments like HALCION continues to decline amid safety concerns and treatment paradigm shifts favoring non-pharmacologic options.

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References
[1] U.S. Food and Drug Administration. (2017). Alcohol, Drugs, and Youth. Regulatory documents on benzodiazepines.
[2] Research and Markets. (2022). Global Insomnia Market - Growth, Trends, and Forecasts.
[3] IMS Health Reports. (2021). Pharmaceutical Sales Data – Benzodiazepines.
[4] European Medicines Agency. (2020). Guideline on the quality, safety, and efficacy of hypnotics.