Imipramine hydrochloride - Generic Drug Details

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

Imipramine hydrochloride is the generic ingredient in five branded drugs marketed by Novartis, Chartwell, Leading, Lederle, Oxford Pharms, Par Pharm, Roxane, Sandoz, Specgx Llc, Strides Pharma, Sun Pharm Industries, Teva, Usl Pharma, Vangard, Watson Labs, West Ward, Abbott, Alra, and Sanofi Aventis Us, and is included in forty NDAs. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for imipramine hydrochloride. Eleven suppliers are listed for this compound.

Summary for imipramine hydrochloride

US Patents:	0
Tradenames:	5
Applicants:	19
NDAs:	40
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	11
Raw Ingredient (Bulk) Api Vendors:	111
Clinical Trials:	52
Patent Applications:	1,486
What excipients (inactive ingredients) are in imipramine hydrochloride?	imipramine hydrochloride excipients list
DailyMed Link:	imipramine hydrochloride at DailyMed

Recent Clinical Trials for imipramine hydrochloride

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

Sponsor	Phase
Wright State University	Phase 1
Benha University	N/A
Wright State Physicians	Phase 1

See all imipramine hydrochloride clinical trials

Pharmacology for imipramine hydrochloride

Drug Class

Tricyclic Antidepressant

Anatomical Therapeutic Chemical (ATC) Classes for imipramine hydrochloride

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

US Patents and Regulatory Information for imipramine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Par Pharm	IMIPRAMINE HYDROCHLORIDE	imipramine hydrochloride	TABLET;ORAL	089422-001	Jul 14, 1987		DISCN	No	No
Oxford Pharms	IMIPRAMINE HYDROCHLORIDE	imipramine hydrochloride	TABLET;ORAL	040751-001	Feb 28, 2008	AB	RX	No	No
Chartwell	IMIPRAMINE HYDROCHLORIDE	imipramine hydrochloride	TABLET;ORAL	090441-003	Mar 11, 2010		DISCN	No	No
Sandoz	IMIPRAMINE HYDROCHLORIDE	imipramine hydrochloride	TABLET;ORAL	085200-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Oxford Pharms	IMIPRAMINE HYDROCHLORIDE	imipramine hydrochloride	TABLET;ORAL	040751-002	Feb 28, 2008	AB	RX	No	No

Imipramine hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Imipramine Hydrochloride

Market Overview

Imipramine hydrochloride, a tricyclic antidepressant, has been a staple in the treatment of depression and childhood enuresis for decades. The market for imipramine hydrochloride has undergone significant changes and is expected to continue its growth trajectory in the coming years.

Current Market Size and Growth Projections

The imipramine hydrochloride API market has experienced a rapid and substantial rise in recent years. According to market research, this trend is expected to continue from 2023 to 2031, with forecasts indicating sustained significant expansion. The market size is projected to grow considerably, driven by increasing demand for antidepressant medications and the expanding global healthcare sector[1].

Market Segmentation

The imipramine hydrochloride API market is segmented based on several key factors:

By Type

• Above 98%
• Above 99%

These purity levels are crucial for pharmaceutical applications, and the demand for higher purity levels is driving market growth[1].

By Application

• Tablets
• Capsules
• Others

The primary applications of imipramine hydrochloride are in the form of tablets and capsules, which are widely used in the treatment of depression and other psychiatric disorders[1].

By Geography

• North America
• Europe
• Asia-Pacific
• South America
• Middle-East and Africa

The Asia-Pacific region is expected to be a significant growth driver due to the large population and increasing healthcare expenditure in countries like China and India[1].

Drivers of Market Growth

Several factors are driving the growth of the imipramine hydrochloride API market:

Increasing Prevalence of Depression

The global prevalence of depression is on the rise, driven by factors such as stress, lifestyle changes, and increasing awareness about mental health. This has led to an increased demand for antidepressant medications like imipramine hydrochloride[4].

Expanding Healthcare Sector

The global healthcare sector is expanding rapidly, with increased investment in mental health services and treatments. This expansion is expected to boost the demand for imipramine hydrochloride[1].

Advancements in Manufacturing

Improvements in manufacturing processes and the development of more efficient production methods have made imipramine hydrochloride more accessible and affordable. This has contributed to the market's growth[1].

Restraints and Challenges

Despite the positive growth trajectory, the market faces several challenges:

Regulatory Hurdles

Stringent regulatory requirements and the need for compliance with various international standards can act as barriers to entry for new manufacturers. Additionally, the concomitant use of imipramine hydrochloride with monoamine oxidase inhibitors is contraindicated, which can limit its use in certain patient populations[5].

Side Effects and Safety Concerns

Imipramine hydrochloride is associated with several side effects, including anticholinergic activity, central nervous system effects, and potential toxicity. These safety concerns can impact market growth and patient adherence to treatment[4].

Competition from Newer Antidepressants

The market for antidepressants is highly competitive, with newer drugs and therapies emerging. This competition can challenge the market share of imipramine hydrochloride, especially if newer drugs offer better efficacy or fewer side effects[4].

Financial Trajectory

The financial performance of the imipramine hydrochloride API market is expected to be robust:

Revenue Projections

The market is projected to generate significant revenue, measured in USD million, across various segments. The revenue growth is anticipated to be steady throughout the forecast period from 2023 to 2031[1].

Key Players and Market Share

Prominent companies such as Jai Radhe Sales, R L Fine Chem, and Teva are key players in the imipramine hydrochloride API market. These companies have established themselves through their product offerings and market-related factors, contributing to the market's financial stability[1].

Market Outlook and Analysis

Porter's 5 Forces Framework

An analysis using Porter's 5 Forces Framework reveals that the market is influenced by factors such as the bargaining power of suppliers, the bargaining power of buyers, the threat of new entrants, the threat of substitute products, and the intensity of competitive rivalry. These forces collectively shape the market dynamics and financial outcomes[1].

Value Chain Analysis

A detailed value chain analysis highlights the critical stages from raw material procurement to the final product delivery. This analysis helps in understanding the cost structure, profit margins, and areas for improvement in the supply chain[1].

Pricing Analysis

The pricing of imipramine hydrochloride API is influenced by factors such as production costs, market demand, and regulatory environments. A thorough pricing analysis is essential to understand the market's financial trajectory and to make informed business decisions[1].

Emerging Trends and Opportunities

Increasing Focus on Mental Health

There is a growing focus on mental health globally, which is expected to drive the demand for antidepressant medications like imipramine hydrochloride. Governments and healthcare organizations are investing more in mental health services, creating new opportunities for market growth[4].

Advancements in Drug Delivery Systems

Advancements in drug delivery systems, such as sustained-release formulations, can enhance the efficacy and patient compliance of imipramine hydrochloride. These innovations can provide a competitive edge and drive market expansion[4].

Conclusion

The imipramine hydrochloride API market is poised for significant growth driven by increasing demand, advancements in manufacturing, and a growing focus on mental health. However, the market must navigate challenges such as regulatory hurdles, side effects, and competition from newer antidepressants.

Key Takeaways

• The imipramine hydrochloride API market is expected to experience substantial growth from 2023 to 2031.
• Market segmentation by type, application, and geography is crucial for understanding growth drivers.
• Increasing prevalence of depression and expanding healthcare sector are key drivers of market growth.
• Regulatory hurdles and side effects are significant challenges.
• Financial performance is projected to be robust, with key players contributing to market stability.
• Emerging trends include a growing focus on mental health and advancements in drug delivery systems.

FAQs

Q: What are the primary applications of imipramine hydrochloride?

A: The primary applications of imipramine hydrochloride are in the treatment of depression and childhood enuresis, typically in the form of tablets and capsules[4].

Q: Which regions are expected to drive the growth of the imipramine hydrochloride API market?

A: The Asia-Pacific region is expected to be a significant growth driver due to the large population and increasing healthcare expenditure in countries like China and India[1].

Q: What are the major side effects associated with imipramine hydrochloride?

A: Imipramine hydrochloride is associated with side effects such as anticholinergic activity, central nervous system effects, and potential toxicity[4].

Q: Can imipramine hydrochloride be used in pediatric patients?

A: Imipramine hydrochloride is not approved for use in pediatric patients due to the risk of suicidal thinking and behavior in children, adolescents, and young adults[5].

Q: What is the mechanism of action of imipramine hydrochloride?

A: Imipramine hydrochloride works by inhibiting the neuronal reuptake of the neurotransmitters norepinephrine and serotonin, increasing their concentration in the synaptic cleft and relieving symptoms of depression[4].

Sources

1. Market Research Intellect, "Global Imipramine HCL API Market Size, Scope And Forecast Report", September 2024.
2. NCBI, "Development of Visible Spectrophotometric Methods for the Determination of Imipramine and Amitriptyline in Pharmaceutical Preparations", November 2023.
3. American Psychiatric Association, "Annual Meeting", April 2011.
4. DrugBank, "Imipramine: Uses, Interactions, Mechanism of Action".
5. FDA, "Imipramine Hydrochloride Tablets USP 10 mg, 25 mg, and 50 mg", 2012.