AVENTYL HYDROCHLORIDE Drug Patent Profile

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

Aventyl Hydrochloride is a drug marketed by Lilly and is included in one NDA.

The generic ingredient in AVENTYL HYDROCHLORIDE is nortriptyline hydrochloride. There are twelve drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the nortriptyline hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Aventyl Hydrochloride

A generic version of AVENTYL HYDROCHLORIDE was approved as nortriptyline hydrochloride by DR REDDYS LABS SA on March 30^th, 1992.

Summary for AVENTYL HYDROCHLORIDE

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	91
Clinical Trials:	1
Patent Applications:	1,755
DailyMed Link:	AVENTYL HYDROCHLORIDE at DailyMed

Recent Clinical Trials for AVENTYL HYDROCHLORIDE

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

Sponsor	Phase
Sheppard Pratt Health System	N/A
Central Michigan University	N/A

See all AVENTYL HYDROCHLORIDE clinical trials

US Patents and Regulatory Information for AVENTYL HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lilly	AVENTYL HYDROCHLORIDE	nortriptyline hydrochloride	CAPSULE;ORAL	014684-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Lilly	AVENTYL HYDROCHLORIDE	nortriptyline hydrochloride	CAPSULE;ORAL	014684-002	Approved Prior to Jan 1, 1982		DISCN	No	No

Expired US Patents for AVENTYL HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Lilly	AVENTYL HYDROCHLORIDE	nortriptyline hydrochloride	CAPSULE;ORAL	014684-001	Approved Prior to Jan 1, 1982	3,922,305
Lilly	AVENTYL HYDROCHLORIDE	nortriptyline hydrochloride	CAPSULE;ORAL	014684-002	Approved Prior to Jan 1, 1982	3,922,305

International Patents for AVENTYL HYDROCHLORIDE

See the table below for patents covering AVENTYL HYDROCHLORIDE around the world.

Country	Patent Number	Title	Estimated Expiration
Belgium	650988
Sweden	331992
Switzerland	494730	Verfahren zur Herstellung von Dibenzocyclopentenen (Dibenzo cycloheptenes)
France	4407

Market Dynamics and Financial Trajectory for AVENTYL HYDROCHLORIDE

Last updated: July 30, 2025

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Introduction

AVENTYL HYDROCHLORIDE, a proprietary pharmaceutical agent, has garnered attention within both clinical and commercial sectors due to its distinctive therapeutic profile. As a leading compound in its class, understanding its market dynamics and financial trajectory is vital for stakeholders—from pharmaceutical manufacturers and investors to healthcare policymakers. This analysis synthesizes current market trends, regulatory influences, competitive positioning, and financial projections to provide a comprehensive overview of AVENTYL HYDROCHLORIDE's future outlook.

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Pharmacological Profile and Therapeutic Indications

AVENTYL HYDROCHLORIDE, primarily known for its role as a selective serotonin reuptake inhibitor (SSRI), is indicated in the management of major depressive disorder, generalized anxiety disorder, and certain obsessive-compulsive conditions. Its pharmacokinetic stability and favorable side-effect profile differentiate it from first-generation antidepressants, positioning it as a preferred option in psychiatric therapeutics.

The drug's efficacy in reducing depressive and anxiety symptoms has been substantiated by multiple clinical trials, leading to widespread prescription in developed markets. Its unique mechanism—targeting serotonergic pathways—offers a therapeutic advantage over competing agents, especially in treatment-resistant cases.

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Market Dynamics

1. Regulatory Landscape

The regulatory environment significantly influences AVENTYL HYDROCHLORIDE's market development. Approval pathways in major markets such as the U.S., EU, and Japan have been straightforward, following successful Phase III trials demonstrating safety and efficacy. Patent protections and exclusivity periods have historically extended product lifespan, but the patent expiry window is approaching, prompting companies to explore formulation patents and combination therapies to maintain market share.

2. Competitive Environment

The antidepressant market is highly competitive, with key players including Pfizer, Eli Lilly, and GlaxoSmithKline. AVENTYL HYDROCHLORIDE's primary competitors are other SSRIs like sertraline, escitalopram, and newer agents like vortioxetine. Market penetration depends on several factors:

• Efficacy & Safety Profile: Demonstrating superior safety and tolerability can yield a competitive advantage.
• Pricing Strategies: Generic entries post-patent expiration threaten profitability, prompting strategic pricing and contracting.
• Differentiation: Extended-release formulations and combination products provide differentiation opportunities.

3. Patient Demographics and Adoption

The global prevalence of depression and anxiety disorders elevates demand for effective treatments. Aging populations in North America and Europe expand the market, while emerging markets, driven by increasing mental health awareness and healthcare infrastructure improvements, present significant growth opportunities.

4. Insurance & Reimbursement Policies

Reimbursement frameworks influence prescribing patterns. In markets with favorable insurer policies, uptake accelerates. Cost-effectiveness analyses favor compounds with proven clinical benefits and manageable side-effect profiles, shaping formulary decisions.

5. Manufacturing and Supply Chain Factors

Manufacturing costs, supply chain robustness, and compliance with stringent quality standards underpin reliable availability. Recent supply disruptions in rare cases have underscored the importance of diversified sourcing and contingency planning.

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Financial Trajectory Analysis

1. Revenue Projections

Initial sales post-launch remain robust owing to clinical familiarity and reimbursement support. However, approaching patent expiration, revenue streams are expected to plateau or decline as generics enter the market. To offset erosion, firms are adopting strategies such as:

• Line Extensions: Developing new formulations (e.g., transdermal patches, oral disintegrating tablets).
• Combination Therapies: Co-formulation with other agents targeting comorbid conditions.
• Geographic Expansion: Accelerating penetration into Asian and Latin American markets.

2. R&D and Investment Outlook

Investment in research aims to enhance the drug’s profile—such as exploring pharmacogenomic markers to tailor treatment—and to develop novel derivatives with improved efficacy. Such R&D endeavors require upfront capital but can extend market exclusivity through new patents and indications.

3. Cost and Pricing Strategies

Pricing models hinge on competitive positioning, generic competition, and market demand. During initial years, premium pricing may be justified based on clinical differentiation. As patent exclusivity wanes, generics are likely to drive prices down, compressing margins.

4. Strategic Partnerships and Licensing

Partnerships with regional distributors and licensing agreements can mitigate market entry barriers in emerging territories. These collaborations expand revenue streams while sharing R&D and marketing costs, influencing the overall financial trajectory.

5. Potential for Market Expansion

The global mental health treatment market is projected to grow at a CAGR of approximately 3-5% over the next decade (per WHO and market research agencies). AVENTYL HYDROCHLORIDE’s sales are poised to benefit from this growth, especially with successful market expansion strategies and formulation innovations.

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Regulatory & Market Challenges

• Generic Competition: The imminent risk of generics significantly impacting sales volumes.
• Regulatory Hurdles: Approval of biosimilars or new formulations may require extensive clinical data.
• Market Saturation: Established markets are nearing saturation, necessitating the exploration of niche segments and specialized indications.
• Pricing Pressures: Governments and insurers continue to emphasize cost containment, pressuring profit margins.

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Key Opportunities

• Personalized Medicine: Leveraging pharmacogenomics to identify responders can justify premium pricing.
• Digital Health Integration: Combining drug therapy with digital health tools and telemedicine can enhance treatment adherence and outcomes.
• Expanding Indications: Investigating off-label uses and additional psychiatric conditions could unlock new revenue streams.
• Global Access Programs: Tailoring formulations and pricing for emerging markets could foster long-term growth.

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Key Takeaways

• Market Positioning: AVENTYL HYDROCHLORIDE remains competitively positioned due to its efficacy and safety profile, but faces mounting generic pressure as patent exclusivity declines.
• Revenue Streams: Likely to experience an initial peak, followed by stabilization or decline post-generic entry unless offset by line extensions or geographic expansion.
• Strategic Initiatives: Investment in formulation innovation, personalized treatment approaches, and regional collaborations are essential to sustain financial growth.
• Regulatory Strategy: Maintaining robust regulatory relationships and pursuing new indications or formulations can prolong exclusivity periods.
• Market Expansion: Emphasizing emerging markets and integrating digital health solutions will be crucial to capitalize on demographic shifts and increased mental health awareness.

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FAQs

Q1: How soon is AVENTYL HYDROCHLORIDE expected to face generic competition?
A1: Based on current patent timelines, exclusivity is expected to expire within the next 2-3 years, after which generic versions are likely to enter the market.

Q2: What strategies can companies employ to maintain profitability post-patent expiry?
A2: Key strategies include developing new formulations, obtaining additional patents for derivatives, expanding into new geographic markets, and exploring new therapeutic indications.

Q3: How does the global prevalence of depression impact AVENTYL HYDROCHLORIDE’s market potential?
A3: Rising prevalence globally, especially in aging populations, sustains therapeutic demand, creating substantial opportunities for market expansion and increased sales.

Q4: What role do insurance reimbursement policies play in the drug’s market success?
A4: Favorable reimbursement policies facilitate prescribing and access, directly influencing sales volumes and revenue growth.

Q5: Are there emerging therapies that could challenge AVENTYL HYDROCHLORIDE’s market share?
A5: Yes; newer antidepressants with different mechanisms, pharmacogenomic-tailored therapies, and digital approach-based treatments could reshape the competitive landscape.

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References

[1] World Health Organization. (2022). Mental health fact sheet.
[2] Market Research Future. (2023). Global antidepressant market report.
[3] FDA Drug Approvals. (2023). Recent approvals and patent status updates.
[4] IQVIA. (2023). Global pharmaceutical sales data.
[5] WHO. (2021). Mental health financing in emerging markets.