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Last Updated: December 22, 2024

TRIVORA-21 Drug Patent Profile


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When do Trivora-21 patents expire, and what generic alternatives are available?

Trivora-21 is a drug marketed by Dr Reddys Labs Sa and is included in one NDA.

The generic ingredient in TRIVORA-21 is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.

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Summary for TRIVORA-21
Drug patent expirations by year for TRIVORA-21

US Patents and Regulatory Information for TRIVORA-21

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Dr Reddys Labs Sa TRIVORA-21 ethinyl estradiol; levonorgestrel TABLET;ORAL-21 074538-001 Dec 18, 1997 DISCN No 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

TRIVORA-21 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Trivora-21

Introduction to Trivora-21

Trivora-21, a combination oral contraceptive, contains levonorgestrel and ethinyl estradiol. It is designed to prevent pregnancy by suppressing ovulation and is part of a broader class of hormonal contraceptives.

Market Overview of Oral Contraceptives

The market for oral contraceptives is highly competitive and influenced by various factors, including regulatory approvals, consumer preferences, and healthcare policies.

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of oral contraceptives. For instance, the approval process for over-the-counter (OTC) status, as seen with Plan B One-Step, can significantly impact market accessibility and sales[3].

Consumer Preferences

Consumer preferences for oral contraceptives can vary widely based on factors such as efficacy, side effects, and convenience. Trivora-21, with its phased dosing regimen, appeals to users seeking a structured and effective contraceptive method[1].

Financial Trajectory

Revenue Streams

The revenue for Trivora-21 is generated primarily through prescription sales. The financial performance can be influenced by the number of prescriptions filled, insurance coverage, and competition from other contraceptive products.

Insurance Coverage and Reimbursement

Insurance coverage is a critical factor in the financial trajectory of Trivora-21. Changes in healthcare policies and insurance reimbursement rates can significantly affect the product's market performance. For example, programs like the Total Care and Cost Improvement Program (TCCI) by CareFirst BlueCross BlueShield can impact how medications are prescribed and reimbursed[5].

Competition

The oral contraceptive market is highly competitive, with numerous products available, including other combination oral contraceptives like Levora and Microgestin. The competitive landscape can drive pricing strategies and marketing efforts to maintain market share[4].

Key Market Dynamics

Efficacy and Safety

The efficacy and safety profile of Trivora-21 are crucial in maintaining its market position. Clinical trials and postmarketing surveillance data are essential in ensuring that the product remains a trusted option for contraception. For instance, the product's contraindications, such as its use in females with current or past breast cancer, must be clearly communicated to healthcare providers and patients[1].

Patient Counseling and Education

Effective patient counseling and education are vital in ensuring the correct use of Trivora-21. This includes informing patients about the product's benefits, potential side effects, and the importance of consistent use to achieve maximum efficacy[1].

Pharmaceutical Trends

Pharmaceutical trends, such as the shift towards more convenient dosing regimens and the integration of technology in healthcare, can influence the market dynamics of Trivora-21. For example, the rise of telehealth services could impact how prescriptions are filled and managed.

Economic Factors

Cost and Pricing

The cost of Trivora-21 and its pricing strategy are significant factors in its financial trajectory. The product's pricing must be competitive with other oral contraceptives while ensuring profitability for the manufacturer.

Healthcare Policies

Healthcare policies, including those related to reproductive health and insurance coverage, can substantially impact the market for Trivora-21. Changes in policies, such as the Affordable Care Act's provisions on contraceptive coverage, can affect demand and revenue.

Market Challenges

Regulatory Hurdles

Regulatory hurdles, such as the need to discontinue Trivora-21 before starting certain Hepatitis C treatments, can pose challenges to its market performance. These contraindications must be carefully managed to avoid adverse reactions and maintain patient trust[1].

Public Perception

Public perception of hormonal contraceptives can influence market dynamics. Concerns about side effects, such as the risk of liver enzyme elevations or the controversy surrounding breast and cervical cancer risks, must be addressed through clear communication and education[1].

Future Outlook

Technological Advancements

Technological advancements in the pharmaceutical industry, such as the development of new delivery systems or digital health solutions, could impact the future of Trivora-21. Integrating technology to enhance patient compliance and monitoring could be a strategic move to maintain market relevance.

Market Expansion

Expanding the market for Trivora-21 could involve targeting new demographics or geographic regions. This might require additional regulatory approvals and marketing strategies tailored to specific markets.

Key Takeaways

  • Regulatory Environment: Regulatory approvals and contraindications significantly impact the market dynamics of Trivora-21.
  • Consumer Preferences: Efficacy, side effects, and convenience are key factors influencing consumer choice.
  • Financial Trajectory: Revenue is driven by prescription sales, insurance coverage, and competitive market positioning.
  • Economic Factors: Cost, pricing, and healthcare policies are crucial in determining the product's financial performance.
  • Market Challenges: Regulatory hurdles, public perception, and competition are significant challenges to overcome.

FAQs

Q: What are the active ingredients in Trivora-21?

A: Trivora-21 contains levonorgestrel and ethinyl estradiol.

Q: How does Trivora-21 prevent pregnancy?

A: Trivora-21 prevents pregnancy by suppressing ovulation.

Q: What are the contraindications for Trivora-21?

A: Trivora-21 is contraindicated in females who currently have or have had breast cancer and in certain cases of Hepatitis C treatment.

Q: How does insurance coverage affect the market for Trivora-21?

A: Insurance coverage and reimbursement rates significantly impact the product's market performance and accessibility.

Q: What are the potential side effects of Trivora-21?

A: Potential side effects include liver enzyme elevations, and there is ongoing controversy about the risk of breast and cervical cancer.

Sources

  1. Trivora: Package Insert / Prescribing Information - Drugs.com
  2. Western Journal of Medicine - Internet Archive
  3. Plan B One-Step Levonorgestrel - FDA
  4. Decision and Order [Redacted Public Version] - FTC
  5. The Total Care and Cost Improvement Program (TCCI) - CareFirst Provider

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