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Last Updated: April 20, 2025

PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE Drug Patent Profile


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Which patents cover Perphenazine And Amitriptyline Hydrochloride, and when can generic versions of Perphenazine And Amitriptyline Hydrochloride launch?

Perphenazine And Amitriptyline Hydrochloride is a drug marketed by Chartwell Rx, Fosun Pharma, Ivax Sub Teva Pharms, Mylan, Par Pharm, Sun Pharm Industries, and Watson Labs. and is included in thirty-five NDAs.

The generic ingredient in PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE is amitriptyline hydrochloride; perphenazine. There are thirteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the amitriptyline hydrochloride; perphenazine profile page.

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Summary for PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
Drug patent expirations by year for PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
Recent Clinical Trials for PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE

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SponsorPhase
Hospital Civil de GuadalajaraPhase 2
University of GuadalajaraPhase 2
Institute of Experimental and Clinical TherapeuticsPhase 2

See all PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE clinical trials

Pharmacology for PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE

US Patents and Regulatory Information for PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Watson Labs PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride; perphenazine TABLET;ORAL 070373-001 Aug 25, 1986 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Watson Labs PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride; perphenazine TABLET;ORAL 070374-001 Aug 25, 1986 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Sun Pharm Industries PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride; perphenazine TABLET;ORAL 071079-001 Nov 12, 1986 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Watson Labs PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride; perphenazine TABLET;ORAL 072540-001 Feb 15, 1989 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Chartwell Rx PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride; perphenazine TABLET;ORAL 073007-001 Oct 17, 1991 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 5 of 5 entries

Market Dynamics and Financial Trajectory for Perphenazine and Amitriptyline Hydrochloride

Market Overview

The combination drug Perphenazine and Amitriptyline Hydrochloride, often marketed under names such as Duo-Vil, Etrafon, Triavil, and Triptafen, is a significant player in the psychiatric medication market. This formulation combines a tricyclic antidepressant (amitriptyline) with a typical antipsychotic (perphenazine), making it a broad-spectrum psychotherapeutic agent[2][4].

Global Market Size and Growth

As of 2023, the global amitriptyline market, which includes formulations like Perphenazine and Amitriptyline Hydrochloride, is estimated to be valued at US$ 607.0 million. This market is expected to exhibit a Compound Annual Growth Rate (CAGR) of 5.6% during the forecast period from 2023 to 2030[3].

Key Drivers of Market Growth

Several factors are driving the growth of the Perphenazine and Amitriptyline Hydrochloride market:

Increasing Prevalence of Mental Disorders

The rising prevalence of anxiety, depression, and other mental health disorders is a significant driver. For instance, the World Health Organization (WHO) reported that over 150 million people in Europe were living with mental disorders in 2021[3].

Product Approvals and Launches

Regulatory approvals, such as the Abbreviated New Drug Application (ANDA) approval for Amitriptyline HCl Tablets by the U.S. FDA, are boosting market growth. These approvals enable more generic versions to enter the market, increasing accessibility and competition[3].

Impact of COVID-19 Pandemic

The COVID-19 pandemic has had a positive impact on the market due to the increased use of amitriptyline for treating post-COVID-19 symptoms such as headaches and migraines. Additionally, the pandemic has exacerbated mental health issues, further driving demand for psychiatric medications[3].

Regional Market Dynamics

North America

North America is expected to dominate the market, holding a 34.8% market share. This is attributed to the presence of major pharmaceutical companies like Accord Healthcare Inc., Viatris Inc., and Sun Pharmaceutical Industries Inc.[3].

Europe

Europe is the second-largest market, driven by an increase in mental health disorders. The region's high prevalence of mental health issues, as reported by the WHO, contributes to the demand for psychiatric medications[3].

Asia Pacific

In the Asia Pacific region, the market is driven by the increasing number of hospitals and hospital pharmacies, particularly in countries like China. This infrastructure growth supports the distribution and consumption of psychiatric medications[3].

Distribution Channels

The distribution channel segment holds significant potential, especially with the rise in the number of pharmacies. In the U.S., for example, there are roughly 60,000 retail pharmacies, which facilitate the availability of these medications[3].

Challenges and Restraints

Despite the growth drivers, several challenges affect the market:

Side Effects and Tolerability

Amitriptyline, a component of the combination drug, is associated with various side effects such as nausea, vomiting, drowsiness, and anticholinergic effects. These side effects can shift patient preference towards alternative treatments, potentially hampering market growth[1][3].

Regulatory Warnings

The drug carries significant regulatory warnings, including the risk of suicidal thinking and behavior in children, adolescents, and young adults. These warnings can impact prescribing practices and patient adherence[5].

Financial Trajectory

The financial trajectory of the Perphenazine and Amitriptyline Hydrochloride market is positive, driven by the increasing demand for psychiatric medications. Here are some key financial indicators:

Market Value

The global amitriptyline market, which includes this combination drug, is valued at US$ 607.0 million in 2023 and is expected to grow at a CAGR of 5.6% until 2030[3].

Revenue Growth

The revenue growth is anticipated to be steady, driven by the increasing prevalence of mental health disorders and the expanding distribution channels. However, the market growth could be tempered by the side effects associated with the drug and regulatory warnings[3].

Key Takeaways

  • The global market for Perphenazine and Amitriptyline Hydrochloride is driven by the increasing prevalence of mental health disorders and regulatory approvals.
  • North America and Europe are the dominant regions, with Asia Pacific showing significant growth potential.
  • The market faces challenges from side effects and regulatory warnings.
  • The financial trajectory is positive, with a projected CAGR of 5.6% until 2030.

FAQs

Q: What are the primary components of Perphenazine and Amitriptyline Hydrochloride? A: The primary components are amitriptyline, a tricyclic antidepressant, and perphenazine, a typical antipsychotic[2].

Q: What are the common side effects of Perphenazine and Amitriptyline Hydrochloride? A: Common side effects include sedation, hypertension, neurological impairments, anticholinergic side effects like dry mouth and constipation, and others[2].

Q: How has the COVID-19 pandemic impacted the market for this drug? A: The pandemic has increased the use of amitriptyline for post-COVID-19 symptoms and exacerbated mental health issues, driving demand for the drug[3].

Q: Which regions are expected to dominate the market for Perphenazine and Amitriptyline Hydrochloride? A: North America and Europe are expected to be the dominant regions, with significant growth potential in the Asia Pacific region[3].

Q: What are the regulatory warnings associated with Perphenazine and Amitriptyline Hydrochloride? A: The drug carries warnings about the risk of suicidal thinking and behavior in children, adolescents, and young adults, and is not approved for treating dementia-related psychosis[5].

Cited Sources

  1. Hotopf, M., Hardy, R., & Lewis, G. (1997). Amitriptyline v. the rest: still the leading antidepressant after 40 years of randomised controlled trials. The British Journal of Psychiatry.
  2. Wikipedia. Amitriptyline/perphenazine.
  3. Coherent Market Insights. Amitriptyline Market Size, Trends and Forecast to 2030.
  4. Drugs.com. Perphenazine Amitriptyline: Package Insert / Prescribing Info.
  5. DailyMed. PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE tablet.

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