NORTRIPTYLINE HYDROCHLORIDE - Generic Drug Details

What are the generic drug sources for nortriptyline hydrochloride and what is the scope of patent protection?

Nortriptyline hydrochloride is the generic ingredient in four branded drugs marketed by Lilly, Ani Pharms, Aurobindo Pharma Ltd, Dr Reddys Labs Sa, Rising, Taro, Teva, Zydus Lifesciences, Specgx Llc, Ranbaxy, Pharm Assoc, and Rubicon, and is included in fifteen NDAs. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for nortriptyline hydrochloride. Twenty-eight suppliers are listed for this compound.

Summary for NORTRIPTYLINE HYDROCHLORIDE

US Patents:	0
Tradenames:	4
Applicants:	12
NDAs:	15
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	28
Raw Ingredient (Bulk) Api Vendors:	92
Clinical Trials:	50
Patent Applications:	2,315
What excipients (inactive ingredients) are in NORTRIPTYLINE HYDROCHLORIDE?	NORTRIPTYLINE HYDROCHLORIDE excipients list
DailyMed Link:	NORTRIPTYLINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for NORTRIPTYLINE HYDROCHLORIDE

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

Sponsor	Phase
Chang Gung Memorial Hospital	Phase 2
Assiut University	N/A
Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude	Phase 2

See all NORTRIPTYLINE HYDROCHLORIDE clinical trials

Pharmacology for NORTRIPTYLINE HYDROCHLORIDE

Drug Class

Tricyclic Antidepressant

Medical Subject Heading (MeSH) Categories for NORTRIPTYLINE HYDROCHLORIDE

Adrenergic Uptake Inhibitors

Antidepressive Agents, Tricyclic

Anatomical Therapeutic Chemical (ATC) Classes for NORTRIPTYLINE HYDROCHLORIDE

N06AA	Non-selective monoamine reuptake inhibitors
N06A	ANTIDEPRESSANTS
N06	PSYCHOANALEPTICS
N	Nervous system

US Patents and Regulatory Information for NORTRIPTYLINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Rising	NORTRIPTYLINE HYDROCHLORIDE	nortriptyline hydrochloride	CAPSULE;ORAL	074234-001	Jul 26, 1993		DISCN	No	No
Dr Reddys Labs Sa	NORTRIPTYLINE HYDROCHLORIDE	nortriptyline hydrochloride	CAPSULE;ORAL	073556-001	Mar 30, 1992	AB	RX	No	No
Ani Pharms	NORTRIPTYLINE HYDROCHLORIDE	nortriptyline hydrochloride	CAPSULE;ORAL	074054-002	Dec 31, 1992		DISCN	No	No
Taro	NORTRIPTYLINE HYDROCHLORIDE	nortriptyline hydrochloride	CAPSULE;ORAL	075520-001	May 8, 2000	AB	RX	No	No

Expired US Patents for NORTRIPTYLINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Specgx Llc	PAMELOR	nortriptyline hydrochloride	CAPSULE;ORAL	018013-004	Approved Prior to Jan 1, 1982	3,922,305
Lilly	AVENTYL HYDROCHLORIDE	nortriptyline hydrochloride	CAPSULE;ORAL	014684-001	Approved Prior to Jan 1, 1982	3,922,305
Ranbaxy	AVENTYL	nortriptyline hydrochloride	SOLUTION;ORAL	014685-001	Approved Prior to Jan 1, 1982	3,922,305
Specgx Llc	PAMELOR	nortriptyline hydrochloride	CAPSULE;ORAL	018013-003	Approved Prior to Jan 1, 1982	3,922,305

NORTRIPTYLINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Nortriptyline Hydrochloride

Market Overview

The global nortriptyline hydrochloride market is poised for significant growth, driven by several key factors. Here is a comprehensive look at the market dynamics and financial trajectory of this drug.

Market Size and Growth

The global nortriptyline hydrochloride market is projected to grow at a Compound Annual Growth Rate (CAGR) of 2.3% from 2024 to 2031. The market is expected to increase from USD 239.7 million in 2023 to USD 287.52 million by 2031[1][3].

Drivers of Market Growth

Increasing Incidences of Nerve Pain and Mood Disorders

The rising prevalence of nerve pain and mood disorders such as depression are major drivers of the market. Nortriptyline hydrochloride is used as a tricyclic antidepressant and for managing neuropathic pain, which is increasingly common due to conditions like diabetic neuropathy[1][3].

Growing Prevalence of Diabetes

The increasing number of individuals suffering from diabetes, projected to reach 783 million by 2045, is expected to boost the demand for nortriptyline hydrochloride. Diabetic neuropathy, a common complication of diabetes, requires medications like nortriptyline hydrochloride for pain management[1].

Research and Development Activities

The pharmaceutical sector's significant investments in research and development, approximately USD 160 billion annually, are driving the demand for nortriptyline hydrochloride. This includes its potential use in drug repurposing, such as its antitumor activities against gastric cancer[1][3].

Regional Market Dynamics

North America

North America accounts for a significant share of the global nortriptyline hydrochloride market. The well-established healthcare sector and increasing prevalence of depression in the region, affecting over 8% of American adults, contribute to this market dominance[1][3].

Asia-Pacific and Other Regions

The Asia-Pacific market is also expected to grow, driven by increasing healthcare investments and a rising awareness of mental health issues. Other regions, including Europe, are also seeing growth due to similar factors[5].

Product Forms and Purity

Capsules and Solutions

Nortriptyline hydrochloride is available in various forms, including capsules and solutions. Capsules are particularly popular due to their ease of administration and varying strengths (10 mg, 25 mg, 50 mg, and 75 mg)[1].

High Purity Demand

There is a growing demand for nortriptyline hydrochloride with more than 99% purity, driven by academic and research institutions as well as medicine manufacturing facilities. High-purity nortriptyline hydrochloride offers higher efficacy, further boosting its demand[1][3].

Competitive Landscape

The global nortriptyline hydrochloride market is competitive, with major manufacturers including Clinigen, Mallinckrodt Pharmaceuticals, Vasudha, Maynepharma, Manus Aktteva Biopharma, Bristol-Myers Squibb, Sandoz, Mylan, and Glenmark Pharmaceuticals. These companies account for a significant portion of the market revenue[5].

Clinical Efficacy and Comparisons

Efficacy in Treating Depression and Neuropathic Pain

Nortriptyline hydrochloride has been shown to be effective in reducing symptoms of depression and neuropathic pain. In a study comparing nortriptyline with duloxetine, nortriptyline appeared superior in symptom reduction, although duloxetine had advantages in addressing anxiety and quality of life[2].

Antitumor Activities

Research has also highlighted the antitumor activities of nortriptyline hydrochloride, particularly in inhibiting gastric cancer through oxidative stress and apoptosis. This potential for drug repurposing further enhances the market demand[1][3].

Future Market Scenario

The demand for nortriptyline hydrochloride is expected to increase over the forecast period due to ongoing research and development activities. The product's potential for drug repurposing and its high efficacy in treating various conditions will continue to drive market growth[1][3].

Key Takeaways

• The global nortriptyline hydrochloride market is projected to grow at a CAGR of 2.3% from 2024 to 2031.
• Increasing incidences of nerve pain, mood disorders, and diabetes are key drivers of market growth.
• North America holds a significant market share due to its well-established healthcare sector and high prevalence of depression.
• High-purity nortriptyline hydrochloride is in high demand due to its efficacy and use in research and medicine manufacturing.
• The market is competitive, with several major pharmaceutical companies involved.

FAQs

What is the projected CAGR for the global nortriptyline hydrochloride market from 2024 to 2031?

The global nortriptyline hydrochloride market is projected to grow at a CAGR of 2.3% from 2024 to 2031[1][3].

What are the primary drivers of the nortriptyline hydrochloride market?

The primary drivers include increasing incidences of nerve pain, mood disorders such as depression, and the growing prevalence of diabetes[1][3].

Which region holds the largest share of the nortriptyline hydrochloride market?

North America holds a significant share of the global nortriptyline hydrochloride market due to its well-established healthcare sector and high prevalence of depression[1][3].

What is the significance of high-purity nortriptyline hydrochloride in the market?

High-purity nortriptyline hydrochloride is in high demand due to its higher efficacy and use in research and medicine manufacturing facilities[1][3].

Which companies are major players in the nortriptyline hydrochloride market?

Major manufacturers include Clinigen, Mallinckrodt Pharmaceuticals, Vasudha, Maynepharma, Manus Aktteva Biopharma, Bristol-Myers Squibb, Sandoz, Mylan, and Glenmark Pharmaceuticals[5].

Sources

1. Market Xcel - Markets and Data: "Nortriptyline Hydrochloride Market Assessment, By Purity, By Form..."
2. Frontiers in Psychiatry: "Comparing the efficacy of duloxetine and nortriptyline in alleviating..."
3. Markets and Data: "Global Nortriptyline Hydrochloride Market Size 2031"
4. JNCCN: "Association of Polypharmacy and Potentially Inappropriate..."
5. QY Research: "Global Nortriptyline Hydrochloride Market Research Report 2024"