Amitriptyline hydrochloride; perphenazine - Generic Drug Details

What are the generic drug sources for amitriptyline hydrochloride; perphenazine and what is the scope of freedom to operate?

Amitriptyline hydrochloride; perphenazine is the generic ingredient in ten branded drugs marketed by Schering, Chartwell Rx, Fosun Pharma, Ivax Sub Teva Pharms, Mylan, Par Pharm, Sun Pharm Industries, Watson Labs, and New River, and is included in thirty-seven NDAs. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for amitriptyline hydrochloride; perphenazine

US Patents:	0
Tradenames:	10
Applicants:	9
NDAs:	37
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	6
Clinical Trials:	1
DailyMed Link:	amitriptyline hydrochloride; perphenazine at DailyMed

Recent Clinical Trials for amitriptyline hydrochloride; perphenazine

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

Sponsor	Phase
Hospital Civil de Guadalajara	Phase 2
University of Guadalajara	Phase 2
Institute of Experimental and Clinical Therapeutics	Phase 2

See all amitriptyline hydrochloride; perphenazine clinical trials

Pharmacology for amitriptyline hydrochloride; perphenazine

Drug Class

Phenothiazine Tricyclic Antidepressant

Anatomical Therapeutic Chemical (ATC) Classes for amitriptyline hydrochloride; perphenazine

N05AB	Phenothiazines with piperazine structure
N05A	ANTIPSYCHOTICS
N05	PSYCHOLEPTICS
N	Nervous system

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

US Patents and Regulatory Information for amitriptyline hydrochloride; perphenazine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Watson Labs	PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE	amitriptyline hydrochloride; perphenazine	TABLET;ORAL	070377-001	Nov 4, 1986		DISCN	No	No
Watson Labs	PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE	amitriptyline hydrochloride; perphenazine	TABLET;ORAL	072540-001	Feb 15, 1989		DISCN	No	No
Ivax Sub Teva Pharms	PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE	amitriptyline hydrochloride; perphenazine	TABLET;ORAL	070939-001	Sep 12, 1986		DISCN	No	No

Expired US Patents for amitriptyline hydrochloride; perphenazine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
New River	TRIAVIL 2-25	amitriptyline hydrochloride; perphenazine	TABLET;ORAL	014715-002	Approved Prior to Jan 1, 1982	3,428,735
Schering	ETRAFON 2-10	amitriptyline hydrochloride; perphenazine	TABLET;ORAL	014713-007	Approved Prior to Jan 1, 1982	3,428,735
New River	TRIAVIL 4-25	amitriptyline hydrochloride; perphenazine	TABLET;ORAL	014715-005	Approved Prior to Jan 1, 1982	3,428,735

Market Dynamics and Financial Trajectory for Amitriptyline Hydrochloride and Perphenazine

Last updated: July 30, 2025

Introduction

The pharmaceutical market landscape for Amitriptyline Hydrochloride and Perphenazine is intricately shaped by evolving clinical guidelines, patent statuses, regulatory policies, and market demand. Both medications, primarily used in psychiatric and neurological disorders, demonstrate distinct market dynamics influenced by their therapeutic profiles, patent landscapes, and alternatives. Analyzing their current trajectories offers insights into future revenue streams and competitive positioning within the mental health therapeutics sector.

---

Market Overview and Therapeutic Significance

Amitriptyline Hydrochloride, a tricyclic antidepressant (TCA), has been a mainstay since its approval in the 1960s. It is prescribed for major depressive disorder, neuropathic pain, and off-label indications such as migraine prophylaxis. Despite newer agents, Amitriptyline remains relevant, especially for treatment-resistant depression and comorbid chronic pain. Market estimates position Amitriptyline as a multi-billion-dollar global antidepressant market segment, with steady demand driven by its affordability and extensive clinical data.

Perphenazine, a typical antipsychotic belonging to the phenothiazine class, has historically been utilized for schizophrenia and other psychotic disorders. While its use has declined with the advent of atypical antipsychotics, it retains niche applicability in certain regions and patient populations, particularly where cost constraints limit access to novel medications. The aging demographic with chronic psychiatric conditions sustains a baseline demand, though overall market shares have contracted.

---

Market Dynamics

Patent Status and Regulatory Landscape

Both drugs are generic staples, with patent protections long expired, leading to widespread availability and intense price competition. This has suppressed pricing power for brand holders, contributing to narrow margins for original manufacturers and emphasizing market volume over price premiums.

Regulatory shifts, including strict controls on off-label use and reimbursement policies, influence prescribing patterns. Recent approvals for generic production further reinforce market saturation, limiting incremental revenue opportunities.

Clinical and Demographic Trends

The rising prevalence of depression and neuropsychological disorders, notably amidst aging populations, sustains demand for Amitriptyline. However, the clinical shift towards SSRIs and SNRIs, attributed to favorable side effect profiles, has dampened growth potential. Nonetheless, Amitriptyline's role in refractory cases and pain management underpins its persistent market presence.

Perphenazine's usage hinges on schizophrenia treatment demand, which remains steady internationally but faces challenges from newer agents promising better tolerability. Its low-cost profile sustains demand in emerging markets, while in developed regions, prescribing has declined due to adverse side effects and the availability of atypical antipsychotics.

Competitive Landscape and Market Share

Both medications face aggressive competition from branded and generically available drugs. While Amitriptyline’s market share is stable largely because of its low cost and longstanding clinical utility, perphenazine's share diminishes as newer, better-tolerated antipsychotics proliferate.

Market saturation, especially in mature markets such as North America and Europe, constrains growth. However, developing nations’ increasing healthcare access maintains consistent demand, buoyed by lower-cost generics.

Pricing and Revenue Trends

Generic competition has driven price erosion, substantially reducing revenue per unit. Manufacturers increasingly focus on market share expansion strategies, including formulation innovations or combination therapies, to sustain revenues.

The pandemic-induced transition towards telemedicine and outpatient management has also impacted prescribing dynamics. Notably, increased mental health awareness has raised prescription volumes, partially offsetting price pressures.

---

Financial Trajectory

Historical Revenue Performance

The revenue trajectory for both drugs historically exhibits decline, owing to patent expiry and competition. Yet, Amitriptyline's global sales remain resilient in pain and depression markets, with estimates around $200–300 million annually for some generic producers (per IQVIA data). Perphenazine's global sales are comparatively modest, largely confined to institutional and emerging market sales, estimated at $50–100 million annually.

Projected Growth and Market Outlook

• Amitriptyline Hydrochloride: The macro trend suggests stable to modest growth aligned with aging populations and high unmet needs in pain and resistant depression segments. The global antidepressant market is projected to grow at approximately 2-3% CAGR over the next five years (Data: MarketsandMarkets), driven by increasing mental health awareness and expanding healthcare access.

• Perphenazine: Market projections are conservative; growth prospects depend heavily on regional healthcare infrastructure and psychiatric treatment paradigms. In regions where cost-effective treatments are prioritized, such as Africa and Asia, demand may stabilize or slightly increase.

Innovative Formulations and Line Extensions

Limited innovation exists for these drugs, though some manufacturers explore extended-release formulations and combination therapies to differentiate offerings and potentially improve revenue levels. However, such strategies are limited by regulatory and market maturity constraints.

Market Risks and Opportunities

Risks:

• Heightened regulatory scrutiny over side effect profiles may lead to increased adverse event reporting.
• Increasing preferences for newer, atypical agents could further diminish market share.
• Price wars among generics sustain margin erosion.

Opportunities:

• Positioning for niche indications or off-label uses with unmet needs.
• Entering emerging markets with tailored pricing strategies.
• Developing formulations with improved tolerability or compliance features.

---

Future Outlook

The long-term financial trajectory for Amitriptyline and Perphenazine appears cautiously stable, albeit with subdued growth potential. Market resilience hinges on demographic trends, clinical practice shifts, and regional health policies. Advanced formulations or combination therapies could act as catalysts for reinvigoration within specific segments. Both drugs exemplify the strategic importance of lifecycle management in mature markets, emphasizing volume-driven sales amid patent expiration.

---

Key Takeaways

• Amitriptyline Hydrochloride sustains its market position owing to its affordability and multifaceted clinical applications, with projected steady demand aligned with aging demographics and chronic pain management needs.
• Perphenazine, facing declining usage in favor of atypical antipsychotics, maintains niche relevance primarily in cost-sensitive markets.
• Patent expirations and widespread generics have curtailed pricing power, shifting revenue models toward volume rather than premium pricing.
• Regional disparities in healthcare access and formulary designs significantly influence market dynamics, with emerging markets offering growth opportunities.
• Innovation, including extended-release formulations and combination therapies, represents a limited yet critical avenue for future revenue enhancement.

---

FAQs

Q1: Will Amitriptyline Hydrochloride regain market share against newer antidepressants?
A1: Unlikely, given the preference for medications with fewer side effects; however, its low cost and efficacy in resistant cases sustain niche demand.

Q2: How do regulatory policies impact the profitability of these drugs?
A2: Stricter safety regulations and reimbursement policies may lower prescribing volume or price ceilings, impacting margins for manufacturers.

Q3: Are there any emerging markets showing increased demand for Amitriptyline and Perphenazine?
A3: Yes, regions like Asia, Africa, and Latin America continue to show robust demand due to affordability and expanding mental health infrastructure.

Q4: What strategic moves can manufacturers pursue to extend product longevity?
A4: Investing in formulation innovations, exploring new indications, and expanding into underserved regions are viable strategies.

Q5: How might the clinical shift towards atypical antipsychotics affect Perphenazine’s market?
A5: It will likely lead to further decline in Perphenazine prescriptions, though cost advantages may sustain limited usage in resource-constrained settings.

---

Sources

[1] IQVIA. “Global Prescription Medication Market Data, 2022.”
[2] MarketsandMarkets. “Antidepressants Market by Type, Region, and Distribution Channel,” 2022.
[3] FDA and EMA regulatory filings.
[4] World Health Organization. “Mental Health Gap Action Programme (mhGAP),” 2021.
[5] Company financial reports and press releases (Pharmaceutical companies manufacturing Amitriptyline and Perphenazine).