IMIPRAMINE HYDROCHLORIDE - Generic Drug Details

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

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 Intl, 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:	1
Clinical Trials:	57
Patent Applications:	3,319
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
VA Office of Research and Development	PHASE2
Menoufia University	NA
Sohag University	NA

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
Sandoz	IMIPRAMINE HYDROCHLORIDE	imipramine hydrochloride	TABLET;ORAL	084936-002	Approved Prior to Jan 1, 1982	AB	RX	No	No
Teva	IMIPRAMINE HYDROCHLORIDE	imipramine hydrochloride	TABLET;ORAL	083729-004	Approved Prior to Jan 1, 1982		DISCN	No	No
Strides Pharma Intl	IMIPRAMINE HYDROCHLORIDE	imipramine hydrochloride	TABLET;ORAL	088276-001	Oct 21, 1983	AB	RX	No	No
Abbott	JANIMINE	imipramine hydrochloride	TABLET;ORAL	017895-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Roxane	IMIPRAMINE HYDROCHLORIDE	imipramine hydrochloride	TABLET;ORAL	083799-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Market Dynamics and Financial Trajectory for Imipramine Hydrochloride

Last updated: August 20, 2025

Introduction

Imipramine Hydrochloride, a tricyclic antidepressant (TCA), has historically played a vital role in managing depression, enuresis, and certain pain syndromes. Since its advent in the 1950s, it became one of the first effective antidepressants, profoundly impacting psychopharmacology. Despite advancements in newer antidepressants, imipramine remains relevant due to its cost-effectiveness, established safety profile, and unique clinical applications. This report examines the current market dynamics and financial trajectory, focusing on factors shaping its future demand, competitive landscape, regulatory environment, and economic prospects.

Market Overview

The global antidepressant market was valued at approximately USD 16.4 billion in 2021 and is projected to grow at a compound annual growth rate (CAGR) of about 2.3% through 2028 [1]. While selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) dominate, imipramine retains niches in treatment-resistant depression and specific off-label uses. Its affordability makes it a critical option in emerging markets, where access to newer medications is limited.

Key Market Drivers

1. Established Therapeutic Efficacy
   Imipramine’s long-standing clinical efficacy and extensive research base sustain its use, especially in cases unresponsive to newer agents [2].

2. Cost-Effectiveness
   Its generics are inexpensive compared to newer antidepressants, fostering continued utilization in low- and middle-income countries (LMICs). According to IQVIA data, imipramine’s average retail price is significantly lower than SSRIs, bolstering its market share in resource-constrained settings.

3. Regulatory Approvals & Prescribing Patterns
   Despite the advent of newer antidepressants with favorable side effect profiles, regulatory agencies have maintained approvals for imipramine. Prescriber preference persists in certain regions, particularly where familiarity and insurance coverages favor traditional therapies.

4. Off-Label Uses & Specialty Indications
   Beyond primary depression treatment, imipramine finds roles in managing enuresis, chronic pain, and migraine prophylaxis. These niche applications safeguard ongoing demand in specialized markets.

Market Challenges

1. Side Effect Profile & Safety Concerns
   The anticholinergic and cardiotoxic side effects associated with TCAs limit widespread application, especially in elderly populations. This safety profile shift favors newer antidepressants with fewer adverse effects [3].

2. Competition from Modern Antidepressants
   SSRIs and SNRIs offer improved tolerability, leading to declining prescription rates. Data indicates a substitution trend, especially in high-income markets where patient compliance is crucial.

3. Regulatory and Manufacturing Constraints
   Generally, imipramine’s manufacturing processes are well-established; however, increasing regulatory scrutiny over synthetic routes and quality control can impact supply chains, especially for generic manufacturers.

Regional Market Dynamics

• North America & Europe
  Market share for imipramine has diminished in these regions due to the prevalence of newer agents. Nonetheless, it remains prescribed in certain outpatient and primary care settings. The focus shifts to off-label applications and compounded formulations as secondary revenue streams.

• Asia-Pacific
  Market growth remains robust, driven by expanding mental health awareness, increasing healthcare access, and lower drug costs. Governments actively promote generics, including imipramine, fostering market stability.

• Latin America & Africa
  Cost-driven markets favor imipramine over costly newer drugs. Pharmaceutical companies that provide affordable formulations benefit from sustained demand, especially in rural and underserved communities.

Financial Trajectory and Future Outlook

Revenue Trends:
Imipramine’s global revenue peaked during the mid-2000s but has steadily declined with pioneer brands facing generic competition and shifting prescriber preferences. Despite this, the drug still generates significant revenue in specific markets, notably where cost considerations dominate.

Forecasted Growth:
Analysts project a slow decline in overall imipramine sales in developed nations, with a CAGR of approximately -1.2% from 2022 to 2030. Conversely, emerging markets are expected to see a CAGR of 3-4% owing to increased generic penetration and growing mental health awareness.

Innovative Opportunities & Strategic Considerations

• Formulation Advances: Development of controlled-release formulations or combination therapies may rejuvenate interest in imipramine.

• Market Expansion: Marketing strategies targeting off-label indications and specialized conditions could expand usage.

• Regulatory Support: Engaging with regulatory bodies to secure approvals for novel indications enhances market longevity.

Intellectual Property & Patent Status

Imipramine itself is off-patent globally, primarily available as generic medication. Patent expirations have democratically opened manufacturing, driving price reductions. Patent landscapes for formulations or delivery systems may still offer opportunities for proprietary development.

Regulatory Environment

Regulatory bodies increasingly emphasize safety, efficacy, and manufacturing standards. While imipramine’s existing approvals are stable, future regulatory challenges may impose stricter manufacturing or labeling requirements, influencing market access and profitability.

Conclusion

The market for Imipramine Hydrochloride remains characterized by slow decline in the high-income regions, buoyed by cost advantages and niche uses. Growing demand in LMICs, driven by affordability and expanding mental health concerns, supports a cautious growth trajectory in emerging markets. Stakeholders should explore formulation innovation, off-label indications, and targeted marketing to maintain relevance amid competition from newer agents.

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Key Takeaways

• Imipramine hydrochloride maintains a niche market driven by cost-effectiveness, especially in emerging economies.
• Competition from SSRIs and SNRIs has reduced its prominence in developed markets; however, off-label uses sustain demand.
• Patent expirations have facilitated generic proliferation, lowering prices and expanding access.
• Safety side effects and the availability of better-tolerated medications limit growth in high-income countries.
• Strategic innovation, including novel formulations and expanding indications, can mitigate decline and foster growth.

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FAQs

1. What factors are influencing the declining prescription rates of Imipramine Hydrochloride in high-income countries?
Imipramine's side effect profile and safety concerns, especially in elderly populations, coupled with the availability of newer antidepressants like SSRIs and SNRIs with better tolerability, have led to decreased prescription rates in high-income countries.

2. How does the cost advantage of generic imipramine impact its market in developing nations?
Low-cost generics enable affordable mental health treatment access in LMICs, where healthcare budgets are constrained. Regulatory policies favoring generics further bolster imipramine’s market share in these regions.

3. Are there any recent innovations or formulations that could revitalize imipramine's market?
Development of controlled-release formulations, combination therapies, or new delivery systems could improve tolerability and adherence, potentially revitalizing interest and expanding off-label uses.

4. What is the future outlook for the revenue of Imipramine Hydrochloride globally?
While revenues are projected to decline gradually in developed regions, expanding markets in Asia-Pacific, Africa, and Latin America may sustain or slightly boost global sales through increased access and favorable pricing.

5. How are regulatory changes likely to affect the manufacturing and marketing of imipramine?
Enhanced safety and manufacturing standards may impose additional compliance costs. However, the off-patent status and widespread approval support ongoing production, provided quality standards are maintained.

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References

[1] Market Research Future, "Antidepressant Market Size & Share," 2022.
[2] Schatzberg, A. F., & Nemeroff, C. B. (2009). "The American Psychiatric Publishing Textbook of Psychopharmacology."
[3] Baker, C. G., & McKenna, W. (2014). "Comparative Safety Profiles of Antidepressants." Journal of Clinical Psychiatry, 75(5), 522-530.