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Last Updated: April 3, 2025

VIVACTIL Drug Patent Profile


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When do Vivactil patents expire, and what generic alternatives are available?

Vivactil is a drug marketed by Chartwell Rx and Teva Womens and is included in three NDAs.

The generic ingredient in VIVACTIL is protriptyline hydrochloride. There are six drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the protriptyline hydrochloride profile page.

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Summary for VIVACTIL
US Patents:0
Applicants:2
NDAs:3
Raw Ingredient (Bulk) Api Vendors: 29
Patent Applications: 4,250
DailyMed Link:VIVACTIL at DailyMed
Drug patent expirations by year for VIVACTIL

US Patents and Regulatory Information for VIVACTIL

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Teva Womens VIVACTIL protriptyline hydrochloride TABLET;ORAL 016012-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Teva Womens VIVACTIL protriptyline hydrochloride TABLET;ORAL 016012-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Chartwell Rx VIVACTIL protriptyline hydrochloride TABLET;ORAL 073644-001 Aug 24, 1995 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Chartwell Rx VIVACTIL protriptyline hydrochloride TABLET;ORAL 073645-001 Aug 24, 1995 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 4 of 4 entries

Market Dynamics and Financial Trajectory for VIVACTIL

Introduction to VIVACTIL

VIVACTIL, known generically as protriptyline, is a tricyclic antidepressant used to treat depression. It works by increasing the activity of serotonin in the brain, a common mechanism for many antidepressant medications[2].

Market Segmentation and Positioning

Drug Class

VIVACTIL falls under the category of tricyclic antidepressants, a class that, although older, still holds a significant place in the treatment of depression. The US anti-depressant drugs market is segmented into various drug classes, including SSRIs, SNRIs, atypical antidepressants, and tricyclic antidepressants. While SSRIs dominate the market, tricyclic antidepressants like VIVACTIL continue to be prescribed, especially in cases where other treatments have failed[1].

Indication

The primary indication for VIVACTIL is the treatment of depression. The major depressive disorder segment is the largest contributor to the antidepressant market, and this trend is expected to continue during the forecast period[1].

Market Growth Drivers

Prevalence of Depression

The high prevalence of depression in the US is a significant driver for the antidepressant market. According to the World Health Organization (WHO), almost 264 million people worldwide suffer from depression, making it a primary cause of disability globally. This high incidence drives the demand for efficient depression management therapies, including medications like VIVACTIL[1].

Public Awareness and Treatment Initiatives

Increasing public awareness of mental health issues and the availability of effective treatments also fuel the growth of the antidepressant market. Government and private initiatives aimed at developing and promoting mental health treatments contribute to this growth[1].

Market Restraints

Generic Competition

One of the major restraints for branded antidepressants like VIVACTIL is the availability of generic versions. Protriptyline, the generic form of VIVACTIL, is available from multiple manufacturers, including EPIC PHARMA LLC, HIKMA, and SIGMAPHARM LABS LLC. This competition can reduce the market share and revenue of the branded version[4].

Side Effects and Compliance

Antidepressants, including VIVACTIL, can have significant side effects such as abdominal cramps, heartburn, and increased sensitivity to sunlight. These side effects can make it difficult for patients to comply with treatment, which can impact the market negatively[2].

Regulatory Standards

The strict regulatory standards for antidepressant drug approval can also act as a barrier. The lengthy and costly clinical trials, along with rising regulatory scrutiny, can delay the approval and introduction of new or updated versions of existing drugs like VIVACTIL[1].

Financial Trajectory

Current Market Value

The US anti-depressant drugs market, which includes VIVACTIL, was valued at $6.9 billion in 2022. This market is projected to grow at a compound annual growth rate (CAGR) of 3.9% from 2022 to 2030, reaching $9.37 billion by 2030[1].

Impact of Generic Versions

The availability of generic versions of VIVACTIL can significantly impact its financial trajectory. Generic drugs are generally less expensive than their branded counterparts, which can reduce the revenue generated by the branded version. However, the overall market growth driven by the increasing prevalence of depression and other mental health conditions can still support the financial performance of antidepressant medications[1][4].

Pricing and Affordability

The pricing of antidepressant drugs, including VIVACTIL, is influenced by the availability of generic versions. Generic protriptyline can make the treatment more affordable for patients, which can increase its usage but may reduce the revenue per unit for the branded version[1].

Key Players and Market Competition

The antidepressant market is highly competitive, with key players such as Eli Lilly and Company, Pfizer Inc., and Bristol-Myers Squibb. The introduction of new drugs and the expansion of product portfolios by these companies contribute to market growth. However, for a specific drug like VIVACTIL, the competition from generic versions and other branded antidepressants can be significant[1].

Regulatory Approvals and Updates

While VIVACTIL itself has been on the market for some time, recent approvals of other antidepressants highlight the evolving landscape of depression treatment. For example, the FDA approval of Spravato (esketamine) for treating major depressive disorder in adults who have not responded to other treatments marks a significant development in the field[1].

Conclusion

The market dynamics for VIVACTIL are influenced by the broader trends in the antidepressant market. While the drug faces challenges from generic competition and side effects, the increasing prevalence of depression and public awareness of mental health issues drive the overall market growth.

Key Takeaways

  • Market Growth: The US anti-depressant drugs market is projected to grow at a CAGR of 3.9% from 2022 to 2030.
  • Generic Competition: The availability of generic protriptyline impacts the revenue of the branded version, VIVACTIL.
  • Side Effects: Significant side effects can affect patient compliance and market performance.
  • Regulatory Standards: Strict regulatory standards can delay the approval of new or updated drugs.
  • Public Awareness: Increasing public awareness of mental health issues drives the demand for antidepressant treatments.

FAQs

  1. What is VIVACTIL used for? VIVACTIL, or protriptyline, is used to treat depression by increasing the activity of serotonin in the brain[2].

  2. Is VIVACTIL available in generic form? Yes, protriptyline, the generic form of VIVACTIL, is available from multiple manufacturers[4].

  3. What are the common side effects of VIVACTIL? Common side effects include abdominal cramps, heartburn, and increased sensitivity to sunlight[2].

  4. How does the availability of generic versions affect VIVACTIL's market performance? The availability of generic versions can reduce the revenue of the branded version due to lower pricing[1][4].

  5. What are the key drivers of the antidepressant market? The key drivers include the rising incidence of depression, increasing public awareness of mental health issues, and the development of new antidepressant drugs[1].

Cited Sources:

[1] https://www.insights10.com/report/usanti-depressants-drugs-market-analysis/ [2] https://www.mayoclinic.org/drugs-supplements/protriptyline-oral-route/description/drg-20072018 [3] https://www.fortunebusinessinsights.com/prescription-drugs-market-102709 [4] https://www.drugs.com/availability/generic-vivactil.html

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