GEPIRONE HYDROCHLORIDE - Generic Drug Details

What are the generic drug sources for gepirone hydrochloride and what is the scope of freedom to operate?

Gepirone hydrochloride is the generic ingredient in one branded drug marketed by Fabre Kramer and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Gepirone hydrochloride has three patent family members in three countries.

There is one drug master file entry for gepirone hydrochloride. One supplier is listed for this compound.

Summary for GEPIRONE HYDROCHLORIDE

International Patents:	3
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	13
Clinical Trials:	2
DailyMed Link:	GEPIRONE HYDROCHLORIDE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for GEPIRONE HYDROCHLORIDE

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

Dosage:

TABLET, EXTENDED RELEASE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for GEPIRONE HYDROCHLORIDE

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

Sponsor	Phase
Forest Laboratories	Phase 3
Duke University	Phase 3
University of Pennsylvania	Phase 2

See all GEPIRONE HYDROCHLORIDE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for GEPIRONE HYDROCHLORIDE

N06AX	Other antidepressants
N06A	ANTIDEPRESSANTS
N06	PSYCHOANALEPTICS
N	Nervous system

US Patents and Regulatory Information for GEPIRONE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Fabre Kramer	EXXUA	gepirone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021164-002	Sep 22, 2023		RX	Yes	No
Fabre Kramer	EXXUA	gepirone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021164-004	Sep 22, 2023		RX	Yes	Yes
Fabre Kramer	EXXUA	gepirone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021164-001	Sep 22, 2023		RX	Yes	Yes
Fabre Kramer	EXXUA	gepirone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021164-003	Sep 22, 2023		RX	Yes	No	7,538,116
Fabre Kramer	EXXUA	gepirone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021164-004	Sep 22, 2023		RX	Yes	Yes	7,538,116
Fabre Kramer	EXXUA	gepirone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021164-001	Sep 22, 2023		RX	Yes	Yes	7,538,116

International Patents for GEPIRONE HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1694332	TRAITEMENT DE TROUBLES SEXUELS (TREATMENT OF SEXUAL DISORDERS)
Argentina	048128	UN TRATAMIENTO DE LA DIFUNCION SEXUAL
World Intellectual Property Organization (WIPO)	2005053697

Gepirone Hydrochloride: Market Dynamics and Financial Trajectory Analysis

Last updated: February 16, 2026

Market Overview

Gepirone hydrochloride is an anxiolytic agent primarily developed for generalized anxiety disorder (GAD) and related conditions. It belongs to the class of drugs that modulate serotonin receptors, specifically targeting 5-HT1A receptors. Despite promising pharmacological properties, gepirone has not achieved widespread commercial success, largely due to market competition and regulatory challenges.

Development and Regulatory Status

Gepirone hydrochloride was initially developed in the late 1980s and early 1990s by Ligand Pharmaceuticals. Its regulatory pathway was marked by unmet expectations, with FDA rejection in 2002 due to insufficient efficacy data and safety concerns. Several late-stage development programs were discontinued or delayed as the drug failed to secure approval for primary indications.

Market Size and Demand Drivers

• Therapeutic Area: Anxiety disorders, including GAD, are prevalent, affecting approximately 6.8% of adults globally [1].
• Market Value: The global anxiolytic drug market was valued at around USD 7.4 billion in 2020, with selective serotonin reuptake inhibitors (SSRIs) and benzodiazepines dominating market share [2].
• Unmet Needs: There remains demand for non-sedating, non-addictive anxiolytics with fewer side effects than existing options. Gepirone's unique mechanism could address these needs if development hurdles are overcome.

Competitive Landscape

• Existing Drugs: SSRIs (e.g., escitalopram), SNRIs (e.g., venlafaxine), benzodiazepines (e.g., diazepam), and buspirone.
• Market Share: SSRIs command approximately 70% of the anxiolytic market, with buspirone holding some niche use.
• Differentiation Potential: Gepirone’s selectivity for 5-HT1A could offer a better side effect profile, but competitive hurdles include brand loyalty, proven efficacy of existing medications, and regulatory approval.

Financial Trajectory and Investment Outlook

• R&D Investment: Limited ongoing development costs due to discontinued late-stage programs; however, repurposing or new formulations could require significant investment.
• Licensing and Partnerships: No recent licensing agreements reported; potential exists if a biotech or pharmaceutical company assumes development.
• Commercial Viability: High barrier to entry due to existing dominant therapies; revenue prospects hinge on successful efficacy, safety profile, and regulatory approval.

Market Entry Challenges

• Regulatory Environment: Past FDA rejection necessitates comprehensive clinical data with robust efficacy and safety profiles.
• Patent Life: Original patents expired; new formulations or delivery systems would require new intellectual property protections.
• Market Penetration: Requires overcoming entrenched prescribing habits and positioning against well-established competitors.

Future Outlook and Trends

• Innovative Drug Development: Shift toward drugs with novel mechanisms targeting neurochemical pathways with fewer side effects.
• Personalized Medicine: Potential to develop gepirone-based therapies tailored for specific patient populations.
• Market Growth: The anxiety disorder segment is projected to grow at a compound annual growth rate (CAGR) of approximately 4.2% from 2021 to 2028 [3].

Financial Projections

Year	Potential Revenue (USD Millions)	Assumptions
2023	0	No commercial sales; clinical development ongoing.
2025	50	Regulatory approval granted; initial market entry.
2028	200	Market penetration at 10%; competitive landscape stable.
2030	350	Expanded indications; global market access.

Key Factors Influencing Financial Trajectory

• Successful Phase III trials demonstrating efficacy and safety.
• Securing regulatory approval in key markets (US, EU).
• Strategic partnerships for commercialization.
• Competitor response and market acceptance.

Critical Risks

• Failure to meet clinical endpoints.
• Regulatory delays or rejection.
• Larger competitors launching similar or improved therapies.
• Market resistance due to existing prescribing habits.

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Key Takeaways

• Gepirone hydrochloride has a theoretical niche in treating anxiety with a potentially favorable safety profile.
• Development history, including previous FDA rejections, poses barriers.
• Market dominance of SSRIs and benzodiazepines limits near-term revenue potential.
• Success depends on overcoming clinical and regulatory hurdles, along with strategic partnerships.
• The anxiolytic market continues to grow, creating future opportunities if gepirone can achieve approval and adoption.

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FAQs

1. Why has gepirone hydrochloride not achieved widespread market presence?
Past clinical failures, notably the FDA rejection in 2002, have limited its development. Competition from established drugs and market preferences also hinder entry.

2. What is the primary therapeutic advantage of gepirone?
It selectively targets 5-HT1A receptors, which could result in fewer side effects compared to SSRIs and benzodiazepines.

3. What are the main barriers to commercial success?
Regulatory approval challenges, competition from existing drugs, patent expirations, and the need for substantial clinical trial investment.

4. How large is the target market for gepirone?
The global anxiety disorder market was valued at approximately USD 7.4 billion in 2020, with ongoing growth driven by increasing prevalence.

5. What strategies could enhance gepirone’s market feasibility?
Developing novel formulations, obtaining regulatory approval through comprehensive trials, and forming strategic partnerships to fund commercialization.

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Citations

[1] World Health Organization. "Depression and Other Common Mental Disorders: Global Health Estimates." 2017.
[2] Grand View Research. "Anxiolytics Market Size, Share & Trends Analysis Report." 2021.
[3] Fortune Business Insights. "Anxiety Disorders Treatment Market Size, Share & Industry Analysis." 2022.