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Last Updated: December 23, 2024

ORTHO-NOVUM 10-21 Drug Patent Profile


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When do Ortho-novum 10-21 patents expire, and what generic alternatives are available?

Ortho-novum 10-21 is a drug marketed by Ortho Mcneil Pharm and is included in one NDA.

The generic ingredient in ORTHO-NOVUM 10-21 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 10-21
Drug patent expirations by year for ORTHO-NOVUM 10-21

US Patents and Regulatory Information for ORTHO-NOVUM 10-21

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 10-21 mestranol; norethindrone TABLET;ORAL-21 012728-001 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 10-21 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of ORTHO-NOVUM 10/21

Introduction to ORTHO-NOVUM 10/21

ORTHO-NOVUM 10/21 is a combined oral contraceptive that contains the progestational compound norethindrone and the estrogenic compound ethinyl estradiol. This medication is part of a broader category of birth control pills that have been a cornerstone in reproductive health for decades.

Historical Context

The introduction of oral contraceptives like ORTHO-NOVUM in the 1960s revolutionized family planning and women's health. The Ortho Pharmaceutical Corporation, which produced ORTHO-NOVUM, was a key player in this market. The popularity of these pills created a new and lucrative market for pharmaceutical companies, as seen with the Ortho-Novum 10/11 brand produced around 1981[4].

Market Demand and Growth

The demand for oral contraceptives has remained steady over the years due to their effectiveness and convenience. ORTHO-NOVUM 10/21, like other combined oral contraceptives, is highly effective when used correctly, with typical accidental pregnancy rates being very low. This efficacy contributes to its enduring market demand[5].

Competitive Landscape

The market for oral contraceptives is highly competitive, with numerous brands and formulations available. ORTHO-NOVUM competes with other well-known brands such as those containing ethinyl estradiol and norgestimate. The competitive landscape is also influenced by alternative contraceptive methods like intrauterine devices (IUDs) and subdermal implants, such as Mirena and Nexplanon[3].

Pricing and Accessibility

The pricing of ORTHO-NOVUM 10/21 can vary depending on the region and availability of generic alternatives. Generally, brand-name oral contraceptives tend to be more expensive than their generic counterparts. However, the availability of lower-cost generic versions has made these medications more accessible to a wider population[3].

Financial Performance

The financial performance of ORTHO-NOVUM 10/21 is tied to the overall market for oral contraceptives. Given the stable demand and the presence of generic alternatives, the revenue from brand-name ORTHO-NOVUM may have seen a decline over the years. However, the overall market for oral contraceptives remains significant, ensuring a steady revenue stream for pharmaceutical companies involved in this segment.

Regulatory and Safety Considerations

Regulatory and safety considerations play a crucial role in the market dynamics of ORTHO-NOVUM 10/21. The FDA has strict guidelines for the use of combined oral contraceptives, including warnings about cardiovascular risks associated with smoking, particularly in women over 35 years old. Additionally, there are contraindications for women with certain medical conditions such as thrombophlebitis, cerebral vascular disease, and known or suspected carcinoma of the breast[1].

Consumer Feedback and Satisfaction

Consumer feedback on ORTHO-NOVUM 10/21, as with other oral contraceptives, is mixed. On platforms like Drugs.com, users have reported both positive and negative effects. For ORTHO-NOVUM 1/35, a similar formulation, 43% of reviewers reported a positive effect, while 29% reported a negative effect[3].

Impact of Generic Alternatives

The availability of generic alternatives has significantly impacted the market dynamics of ORTHO-NOVUM 10/21. Generic versions of norethindrone and ethinyl estradiol are widely available, offering a cost-effective option for consumers. This has led to a shift in market share from brand-name products to generics, affecting the financial trajectory of ORTHO-NOVUM 10/21.

Future Outlook

The future outlook for ORTHO-NOVUM 10/21 and similar oral contraceptives is influenced by several factors, including advances in contraceptive technology, changes in regulatory environments, and shifts in consumer preferences. With the ongoing development of new contraceptive methods, the market is likely to remain competitive. However, the established efficacy and convenience of combined oral contraceptives ensure they will continue to be a viable option for many women.

Key Takeaways

  • Stable Demand: ORTHO-NOVUM 10/21 benefits from stable demand due to its effectiveness in preventing pregnancy.
  • Competitive Market: The market is highly competitive with numerous brands and alternative contraceptive methods.
  • Pricing and Accessibility: The availability of generic alternatives has made oral contraceptives more accessible but has also impacted the revenue of brand-name products.
  • Regulatory Considerations: Strict FDA guidelines and contraindications affect the use and market dynamics of ORTHO-NOVUM 10/21.
  • Consumer Feedback: Mixed consumer feedback reflects the varied experiences with oral contraceptives.

FAQs

Q: What are the active ingredients in ORTHO-NOVUM 10/21? A: The active ingredients are norethindrone and ethinyl estradiol.

Q: What are the contraindications for using ORTHO-NOVUM 10/21? A: Contraindications include conditions such as thrombophlebitis, cerebral vascular disease, and known or suspected carcinoma of the breast.

Q: How does smoking affect the use of ORTHO-NOVUM 10/21? A: Smoking increases the risk of serious cardiovascular events, particularly in women over 35 years old.

Q: Are there generic alternatives available for ORTHO-NOVUM 10/21? A: Yes, generic versions of norethindrone and ethinyl estradiol are available.

Q: What is the typical dosage regimen for ORTHO-NOVUM 10/21? A: The dosage regimen typically involves a 28-day cycle with a combination of active and inert pills.

Sources

  1. FDA Label for ORTHO-NOVUM Tablets: AccessData.FDA.gov
  2. Ethinyl Estradiol and Norgestimate (Oral Route): Mayo Clinic
  3. Ortho-Novum 1/35 Alternatives Compared: Drugs.com
  4. Ortho-Novum 10/11 Oral Contraceptive: Smithsonian Institution
  5. Ortho-Novum: Package Insert / Prescribing Information: Drugs.com

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