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Last Updated: December 22, 2024

TERAZOL 3 Drug Patent Profile


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Which patents cover Terazol 3, and when can generic versions of Terazol 3 launch?

Terazol 3 is a drug marketed by Janssen Pharms and is included in two NDAs.

The generic ingredient in TERAZOL 3 is terconazole. There are six drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the terconazole profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Terazol 3

A generic version of TERAZOL 3 was approved as terconazole by TARO on April 6th, 2004.

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Summary for TERAZOL 3
US Patents:0
Applicants:1
NDAs:2
Raw Ingredient (Bulk) Api Vendors: 59
Patent Applications: 4,892
DailyMed Link:TERAZOL 3 at DailyMed
Drug patent expirations by year for TERAZOL 3

US Patents and Regulatory Information for TERAZOL 3

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Pharms TERAZOL 3 terconazole CREAM;VAGINAL 019964-001 Feb 21, 1991 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Janssen Pharms TERAZOL 3 terconazole SUPPOSITORY;VAGINAL 019641-001 May 24, 1988 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

TERAZOL 3 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Terazol 3

Introduction

Terazol 3, a brand name for the antifungal medication terconazole, has been a significant player in the treatment of vaginal yeast infections. To understand its market dynamics and financial trajectory, it is crucial to delve into its history, formulation, market factors, and the broader pharmaceutical industry context.

Approval and Formulations

Terazol 3 was approved by the FDA in two formulations: a vaginal cream and a vaginal suppository. The cream was approved on February 21, 1991, with a strength of 0.8%, while the suppository was approved on May 24, 1988, with a strength of 80mg. However, both of these formulations have been discontinued[1].

Patent Status and Market Exclusivity

The discontinuation of Terazol 3 formulations is significant in understanding its market dynamics. Patent protection and market exclusivity play critical roles in the pharmaceutical industry. When a drug's patent expires, it opens the door for generic versions, which can significantly reduce the market share and revenue of the original brand-name drug. However, in the case of Terazol 3, the discontinuation rather than patent expiration has impacted its market presence[1].

Impact of Discontinuation

The discontinuation of Terazol 3 means that patients and healthcare providers must seek alternative treatments for vaginal yeast infections. This shift can lead to increased competition among other antifungal medications, potentially altering market shares and pricing strategies within the therapeutic class.

Market Competition

The antifungal market is competitive, with several other drugs available for treating vaginal yeast infections. The absence of Terazol 3 from the market allows other brand-name and generic drugs to capture its former market share. Factors such as efficacy, side effects, and patient preference influence the choice of alternative treatments, which in turn affect the financial performance of competing drugs[5].

Pricing Dynamics

Pricing in the pharmaceutical industry is complex and influenced by various factors, including patent status, market competition, and regulatory environments. For brand-name drugs like Terazol 3, extraordinary price increases can occur due to limited competition and patent protection. However, once a drug is discontinued, these pricing dynamics no longer apply, and the focus shifts to the pricing strategies of the remaining competitors[4].

Role of Generic Drugs

Generic drugs often enter the market after the patent of a brand-name drug expires, offering a more affordable alternative. Although Terazol 3 does not have a generic version currently available due to its discontinuation, the presence of generic antifungal drugs in the market can significantly impact the pricing and market share of other brand-name drugs in the same therapeutic class[1].

Corporate Consolidations and Market Domination

Corporate consolidations and the transfer of drug rights can also influence market dynamics. Large pharmaceutical companies acquiring smaller ones or specific drug rights can lead to fewer competitors and greater market domination. This consolidation can result in higher prices and reduced innovation, as seen in other sectors of the pharmaceutical industry[4].

Consumer and Healthcare Provider Influence

In the healthcare market, consumers (patients) often do not directly influence demand due to the involvement of third-party payers (insurance companies). Healthcare providers play a significant role in choosing treatments, which can affect the market share and financial performance of drugs. The discontinuation of Terazol 3 would require healthcare providers to adapt their treatment protocols, potentially favoring other drugs with similar efficacy and safety profiles[4].

Financial Implications

The financial trajectory of a discontinued drug like Terazol 3 is marked by a decline in revenue. Since both formulations of Terazol 3 have been discontinued, the revenue generated from this drug has ceased. This loss can impact the overall financial performance of the manufacturer, Janssen Pharmaceuticals, and may necessitate a shift in focus towards other products or the development of new drugs.

Regulatory Considerations

Regulatory bodies play a crucial role in ensuring the safety and efficacy of drugs. The discontinuation of Terazol 3 might be due to various reasons, including regulatory issues or market demand. Regulatory changes and strict guidelines can also affect the financial trajectory of pharmaceutical companies by influencing the approval and marketing of new drugs[1].

Public Health Impact

The discontinuation of a drug like Terazol 3 can have public health implications, particularly if it was a preferred treatment for certain patient groups. Alternative treatments must be effective and accessible to ensure that patients continue to receive adequate care. Public health initiatives and educational programs may be necessary to inform healthcare providers and patients about available alternatives[1].

Industry Trends and Future Outlook

The pharmaceutical industry is constantly evolving, with new drugs and treatments being developed. The trend towards personalized medicine and the increasing use of generic drugs are significant factors shaping the industry. For companies like Janssen Pharmaceuticals, investing in research and development to bring new drugs to market is crucial for maintaining market presence and financial stability[3].

Key Takeaways

  • Discontinuation Impact: The discontinuation of Terazol 3 has removed it from the market, affecting patient treatment options and the financial performance of Janssen Pharmaceuticals.
  • Market Competition: Other antifungal drugs have gained market share, influencing pricing and competition within the therapeutic class.
  • Pricing Dynamics: The absence of Terazol 3 from the market eliminates its pricing influence, but other factors like patent status and competition continue to shape the market.
  • Regulatory and Public Health: Regulatory considerations and public health needs are critical in managing the discontinuation of essential medications.
  • Financial Trajectory: The discontinuation has resulted in a loss of revenue for Janssen Pharmaceuticals, necessitating a focus on other products or new drug development.

FAQs

What were the formulations of Terazol 3?

Terazol 3 was available in two formulations: a 0.8% vaginal cream and an 80mg vaginal suppository[1].

Why were the formulations of Terazol 3 discontinued?

The exact reasons for the discontinuation are not specified, but it could be due to various factors including regulatory issues, market demand, or strategic decisions by the manufacturer[1].

How does the discontinuation of Terazol 3 affect the market?

The discontinuation has led to increased competition among other antifungal medications, potentially altering market shares and pricing strategies within the therapeutic class[5].

What are the financial implications of discontinuing Terazol 3?

The discontinuation has resulted in a loss of revenue for Janssen Pharmaceuticals, which may necessitate a shift in focus towards other products or the development of new drugs[1].

How does the pharmaceutical industry's trend towards generic drugs affect Terazol 3?

Although Terazol 3 does not have a generic version, the presence of generic antifungal drugs in the market can significantly impact the pricing and market share of other brand-name drugs in the same therapeutic class[1].

What role do regulatory bodies play in the discontinuation of drugs like Terazol 3?

Regulatory bodies ensure the safety and efficacy of drugs. The discontinuation of Terazol 3 might be due to regulatory issues or strict guidelines, which can affect the financial trajectory of pharmaceutical companies[1].

Sources

  1. Generic Terazol 3 Availability - Drugs.com
  2. Degradation of onco-proteins and oncogenic mediator proteins as a therapeutic route to treat acute leukaemia - UCL Discovery
  3. Natural Products as Sources of New Drugs over the Nearly Four Decades from 01JAN1981 to 30SEP2019 - ACS Publications
  4. Brand-Name Prescription Drug Pricing - GAO
  5. Terconazole - Drug Targets, Indications, Patents - Patsnap Synapse

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