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-eight 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:	92
Clinical Trials:	1
Patent Applications:	1,574
DailyMed Link:	AVENTYL HYDROCHLORIDE at DailyMed

Recent Clinical Trials for AVENTYL HYDROCHLORIDE

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

Sponsor	Phase
Central Michigan University	N/A
Sheppard Pratt Health System	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
Lilly	AVENTYL HYDROCHLORIDE	nortriptyline hydrochloride	CAPSULE;ORAL	014684-002	Approved Prior to Jan 1, 1982

International Patents for AVENTYL HYDROCHLORIDE

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

Country	Patent Number	Title	Estimated Expiration
Germany	1468341
France	4407
Belgium	650988
Sweden	331992
Switzerland	494730	Verfahren zur Herstellung von Dibenzocyclopentenen (Dibenzo cycloheptenes)

AVENTYL HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Nortriptyline Hydrochloride (Aventyl)

Introduction

Nortriptyline hydrochloride, marketed under the brand name Aventyl among others, is a tricyclic antidepressant (TCA) that has been widely used for the treatment of depression and other psychiatric conditions. Here, we delve into the market dynamics and financial trajectory of this drug, highlighting key factors influencing its growth and future prospects.

Market Size and Growth

The global nortriptyline hydrochloride market is anticipated to experience steady growth over the forecast period of 2024-2031. The market is projected to grow at a Compound Annual Growth Rate (CAGR) of 2.3%, increasing from USD 239.7 million in 2023 to USD 287.52 million by 2031[1][4].

Driving Factors

Several factors are driving the growth of the nortriptyline hydrochloride market:

Increasing Prevalence of Mood Disorders

The rising prevalence of mood disorders such as depression is a significant driver. In North America, for instance, more than 8% of American adults, approximately 21 million individuals, are affected by depression, according to Mental Health America[1][4].

Growing Demand for Chronic Pain Treatment

Nortriptyline hydrochloride is also used in the treatment of chronic pain, which is another major factor supporting market expansion. The increasing incidences of individuals suffering from chronic pain are driving the demand for medications that include nortriptyline hydrochloride[1][4].

Investments in Research and Development

The presence of a well-established healthcare sector and increasing investments by pharmaceutical, healthcare, and biotechnology companies in research and development activities are bolstering the demand for nortriptyline hydrochloride. These investments are crucial for the development of new formulations and applications of the drug[1][4].

Market Segments

The nortriptyline hydrochloride market can be segmented based on several criteria:

Purity

There is a rising demand for high-purity nortriptyline hydrochloride, particularly for more than 99% purity, which is driving market growth. High-purity formulations are essential for ensuring the efficacy and safety of the drug[1].

Form

Nortriptyline hydrochloride is available in various forms, including capsules and tablets. The choice of form depends on the specific application and patient needs[3].

Application

The drug is primarily used for the treatment of depression but also finds applications in treating neuropathic pain, attention deficit hyperactivity disorder (ADHD), smoking cessation, and anxiety, although it is not a preferred treatment for the latter conditions[2].

Regional Analysis

The market for nortriptyline hydrochloride is geographically diverse, with significant growth expected in various regions:

North America

North America is a key market due to the high prevalence of depression and chronic pain in the region. The well-established healthcare sector and ongoing research and development activities further support market growth[1][4].

Europe, South America, Asia-Pacific, and Middle East and Africa

These regions also show potential for growth, driven by increasing healthcare expenditures and the expanding need for effective treatments for mood disorders and chronic pain[4].

Key Players

Several companies are actively involved in the production and distribution of nortriptyline hydrochloride:

Anant Pharmaceuticals Pvt. Ltd.

HRV Global Life Sciences

Vasudha Pharma Chem Ltd.

Centaur Pharmaceuticals Pvt. Ltd.

Dipharma Inc.

Taro Pharmaceutical Industries Ltd.

Sigma-Aldrich (Merck Group)

LGM Pharma

Tiefenbacher API + Ingredients GmbH & Co. KG

Tokyo Chemical Industry (India) Pvt. Ltd.[4]

These companies are engaged in continuous research and development, and some are collaborating with other organizations to enhance their R&D activities, which is expected to provide lucrative growth opportunities for the market.

Challenges and Considerations

Despite the growth prospects, there are several challenges and considerations associated with nortriptyline hydrochloride:

Side Effects and Contraindications

Nortriptyline hydrochloride has several side effects, including dry mouth, constipation, blurry vision, and serious conditions like seizures and heart issues. It is contraindicated in patients with certain medical conditions, such as recent heart attacks and concurrent use with MAO inhibitors[2][5].

Regulatory Environment

The use of nortriptyline hydrochloride is subject to regulatory oversight. For instance, it is not recommended for young people due to the risk of increased suicidality in the 18–24 age group initiating treatment[2].

Financial Trajectory

The financial trajectory of the nortriptyline hydrochloride market is positive, driven by the increasing demand and expanding applications of the drug.

Revenue Forecast

The market is expected to grow from USD 239.7 million in 2023 to USD 287.52 million by 2031, reflecting a steady increase in revenue over the forecast period[1][4].

Investment and R&D Activities

The ongoing investments in research and development by key players are expected to enhance the market's financial performance. Collaborations and acquisitions, such as Viatris Inc.'s sale of its Active Pharmaceutical Ingredients (API) business to Iquest Enterprises, indicate a dynamic and evolving market landscape[4].

Key Takeaways

• The global nortriptyline hydrochloride market is projected to grow at a CAGR of 2.3% from 2024 to 2031.
• Increasing prevalence of mood disorders and chronic pain are key drivers of market growth.
• High-purity formulations and ongoing R&D activities are crucial for market expansion.
• North America is a significant market due to its well-established healthcare sector and high prevalence of depression.
• Key players are investing heavily in R&D and collaborations to support market growth.

FAQs

What is nortriptyline hydrochloride used for?

Nortriptyline hydrochloride is primarily used for the treatment of depression but also finds applications in treating neuropathic pain, ADHD, smoking cessation, and anxiety[2].

What is the projected growth rate of the nortriptyline hydrochloride market?

The market is projected to grow at a CAGR of 2.3% during the forecast period of 2024-2031[1][4].

Which regions are expected to drive the growth of the nortriptyline hydrochloride market?

North America, Europe, South America, Asia-Pacific, and the Middle East and Africa are expected to drive market growth, with North America being a key region due to its high prevalence of depression and chronic pain[1][4].

What are the common side effects of nortriptyline hydrochloride?

Common side effects include dry mouth, constipation, blurry vision, sleepiness, and low blood pressure with standing. Serious side effects may include seizures, increased risk of suicide in young people, urinary retention, glaucoma, mania, and heart issues[2][5].

Can nortriptyline hydrochloride be used during pregnancy or breastfeeding?

Nortriptyline hydrochloride may cause problems if taken during pregnancy, and its use during breastfeeding appears to be relatively safe, but the potential benefits against the potential risks should be weighed[2][5].

Which companies are key players in the nortriptyline hydrochloride market?

Key players include Anant Pharmaceuticals Pvt. Ltd., HRV Global Life Sciences, Vasudha Pharma Chem Ltd., Centaur Pharmaceuticals Pvt. Ltd., Dipharma Inc., Taro Pharmaceutical Industries Ltd., and others[4].