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Last Updated: December 23, 2024

ORTHO-NOVUM 2-21 Drug Patent Profile


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When do Ortho-novum 2-21 patents expire, and what generic alternatives are available?

Ortho-novum 2-21 is a drug marketed by Ortho Mcneil Pharm and is included in one NDA.

The generic ingredient in ORTHO-NOVUM 2-21 is mestranol; norethindrone. There are eleven drug master file entries for this compound. Additional details are available on the mestranol; norethindrone profile page.

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Summary for ORTHO-NOVUM 2-21
Drug patent expirations by year for ORTHO-NOVUM 2-21

US Patents and Regulatory Information for ORTHO-NOVUM 2-21

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ortho Mcneil Pharm ORTHO-NOVUM 2-21 mestranol; norethindrone TABLET;ORAL-21 012728-005 Approved Prior to Jan 1, 1982 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

ORTHO-NOVUM 2-21 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ORTHO-NOVUM 2-21

Introduction

ORTHO-NOVUM 2-21, a combined oral contraceptive containing norethindrone and ethinyl estradiol, is a widely used medication for preventing pregnancy and treating certain menstrual disorders. Understanding the market dynamics and financial trajectory of this drug is crucial for pharmaceutical companies, investors, and healthcare providers.

Market Overview

Demand and Usage

ORTHO-NOVUM 2-21 is part of the broader market for combined oral contraceptives, which are highly effective methods of contraception. The demand for these products is driven by the need for reliable and convenient birth control methods. According to clinical data, oral contraceptives like ORTHO-NOVUM have a low failure rate, making them a preferred choice for many women[3].

Competitive Landscape

The market for oral contraceptives is competitive, with several brands and formulations available. ORTHO-NOVUM competes with other combined oral contraceptives such as Necon, Nelova, and Demulen, as well as with other contraceptive methods like IUDs (e.g., Mirena) and implants (e.g., Nexplanon)[4].

Regulatory Environment

Approvals and Indications

ORTHO-NOVUM 2-21 is approved by regulatory bodies such as the FDA for the prevention of pregnancy in women who choose this method of contraception. It is also indicated for the treatment of severe acne. The drug's approval and indications play a significant role in its market presence and usage[1][3].

Safety and Contraindications

The regulatory environment also includes strict guidelines regarding the safety and contraindications of the drug. For instance, ORTHO-NOVUM is contraindicated in women with certain medical conditions such as thrombophlebitis, cerebral vascular or coronary artery disease, and known or suspected carcinoma of the breast. These contraindications can affect its market share and financial performance[1].

Financial Performance

Revenue and Sales

The financial performance of ORTHO-NOVUM 2-21 is influenced by its sales and revenue. As a widely prescribed contraceptive, it generates significant revenue for its manufacturers. The sales figures are typically high due to the consistent demand for birth control methods. However, the revenue can be affected by factors such as generic competition, pricing strategies, and market trends[4].

Pricing and Generic Competition

The pricing of ORTHO-NOVUM 2-21 is a critical factor in its financial trajectory. The availability of generic versions can impact the pricing and revenue of the brand-name drug. Generic alternatives often offer lower-cost options, which can attract price-sensitive consumers and reduce the market share of the brand-name product[4].

Market Trends

Shift to Generic and Biosimilar Options

There is a growing trend towards the use of generic and biosimilar drugs due to their cost-effectiveness. This trend can affect the sales and revenue of brand-name drugs like ORTHO-NOVUM 2-21. Pharmaceutical companies may need to adjust their pricing strategies or invest in new formulations to maintain market share[4].

Increasing Awareness and Access

Efforts to increase awareness and access to contraceptive methods have been on the rise, driven by public health initiatives and advocacy groups. This increased awareness can lead to higher demand for oral contraceptives, benefiting drugs like ORTHO-NOVUM 2-21[3].

Consumer Preferences and Satisfaction

User Reviews and Ratings

Consumer satisfaction plays a crucial role in the market dynamics of any drug. ORTHO-NOVUM 2-21 has mixed reviews, with some users reporting positive effects while others experience side effects. For example, on Drugs.com, ORTHO-NOVUM 7/7/7 (a similar formulation) has an average rating of 6.9 out of 10, with 65% of reviewers reporting a positive effect[4].

Side Effects and Adverse Reactions

Common side effects such as weight gain, headaches, and changes in menstrual bleeding patterns can influence consumer preferences. Weight gain, in particular, has been a significant reason for discontinuation in some cases[5].

Healthcare System and Insurance Coverage

Reimbursement and Insurance

The financial trajectory of ORTHO-NOVUM 2-21 is also influenced by healthcare system policies and insurance coverage. In many countries, oral contraceptives are covered by insurance plans, making them more accessible and affordable for consumers. Changes in insurance policies or reimbursement rates can significantly impact the drug's sales and revenue[2].

Future Outlook

Innovations and New Formulations

The future outlook for ORTHO-NOVUM 2-21 depends on innovations in contraceptive technology and the introduction of new formulations. Pharmaceutical companies are continually developing new products with improved efficacy and safety profiles, which can either complement or compete with existing products like ORTHO-NOVUM 2-21[5].

Regulatory Changes

Regulatory changes, such as updates in safety guidelines or new contraindications, can also impact the market dynamics and financial performance of the drug. Manufacturers must stay compliant with these changes to maintain market approval and consumer trust[1].

Key Takeaways

  • High Demand: ORTHO-NOVUM 2-21 benefits from a high demand for reliable birth control methods.
  • Competitive Market: The drug competes with other oral contraceptives and contraceptive methods.
  • Regulatory Compliance: Strict safety guidelines and contraindications affect its market presence.
  • Financial Performance: Revenue is influenced by sales, pricing, and generic competition.
  • Consumer Satisfaction: Mixed user reviews and side effects impact consumer preferences.
  • Healthcare Policies: Insurance coverage and reimbursement rates significantly influence accessibility and affordability.

FAQs

What are the primary indications for ORTHO-NOVUM 2-21?

ORTHO-NOVUM 2-21 is primarily indicated for the prevention of pregnancy in women who choose this method of contraception. It is also used to treat severe acne.

What are the common side effects of ORTHO-NOVUM 2-21?

Common side effects include weight gain, headaches, and changes in menstrual bleeding patterns.

Can ORTHO-NOVUM 2-21 be used by women over 35 who smoke?

No, combination oral contraceptives like ORTHO-NOVUM 2-21 should not be used by women over 35 who smoke due to increased cardiovascular risks.

How does the availability of generic versions affect the market for ORTHO-NOVUM 2-21?

The availability of generic versions can reduce the market share and revenue of ORTHO-NOVUM 2-21 by offering lower-cost alternatives.

What role do insurance policies play in the financial trajectory of ORTHO-NOVUM 2-21?

Insurance policies significantly influence the accessibility and affordability of ORTHO-NOVUM 2-21, with coverage affecting its sales and revenue.

Sources

  1. FDA Label for ORTHO-NOVUM Tablets: Accessdata.fda.gov
  2. Sedgwick County, Kansas Division of Finance Report: Sedgwickcounty.org
  3. RxList - Ortho-Novum: Rxlist.com
  4. Drugs.com - Ortho-Novum 7/7/7 Alternatives: Drugs.com
  5. Update on Contraception: Benefits and Risks of the New Formulations: CCJM.org

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