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Last Updated: December 23, 2024

LOW-OGESTREL-28 Drug Patent Profile


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Which patents cover Low-ogestrel-28, and when can generic versions of Low-ogestrel-28 launch?

Low-ogestrel-28 is a drug marketed by Dr Reddys Labs Sa and is included in one NDA.

The generic ingredient in LOW-OGESTREL-28 is ethinyl estradiol; norgestrel. There are twenty-six drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norgestrel profile page.

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Summary for LOW-OGESTREL-28
Drug patent expirations by year for LOW-OGESTREL-28

US Patents and Regulatory Information for LOW-OGESTREL-28

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 LOW-OGESTREL-28 ethinyl estradiol; norgestrel TABLET;ORAL-28 075288-002 Jul 28, 1999 AB RX 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

LOW-OGESTREL-28 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Low-Ogestrel-28

Introduction to Low-Ogestrel-28

Low-Ogestrel-28 is a combination oral contraceptive containing the progestational compound norgestrel and the estrogenic compound ethinyl estradiol. It is widely used for the prevention of pregnancy and is available by prescription only[2][4].

Market Demand and User Base

The demand for oral contraceptives like Low-Ogestrel-28 is driven by the need for effective and convenient methods of birth control. The user base includes women of reproductive age who seek to prevent pregnancy. The market is influenced by factors such as reproductive health policies, access to healthcare, and personal preferences regarding contraception.

Competitive Landscape

The market for oral contraceptives is highly competitive, with numerous brands and generic options available. Low-Ogestrel-28 competes with other combination oral contraceptives as well as progestin-only pills like Opill. The competitive landscape is characterized by brand loyalty, pricing strategies, and the availability of generic alternatives[1].

Pricing and Cost Considerations

Low-Ogestrel-28 is generally priced higher than some of its generic counterparts but lower than certain brand-name alternatives. The cost can vary depending on the pharmacy, insurance coverage, and location. Generic versions of similar contraceptives can offer a more affordable option, which may impact the financial trajectory of Low-Ogestrel-28[1][5].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of Low-Ogestrel-28. The drug is subject to strict FDA regulations and must comply with guidelines related to safety, efficacy, and labeling. Any changes in regulatory policies or the introduction of new guidelines can significantly impact the market position of Low-Ogestrel-28[3][4].

Side Effects and Safety Concerns

Low-Ogestrel-28 is associated with several potential side effects and safety concerns, including an increased risk of thrombophlebitis, arterial thromboembolism, and liver tumors. These risks can affect market demand and the financial performance of the drug, as they may lead to increased scrutiny and potential legal liabilities[2][3][4].

Usage and Dosage

The dosage regimen for Low-Ogestrel-28 involves taking one white active tablet daily for 21 consecutive days, followed by one peach inert tablet daily for 7 consecutive days. Compliance with this regimen is crucial for maximum contraceptive effectiveness. Any issues related to adherence or ease of use can impact market dynamics[2][5].

Financial Performance

The financial performance of Low-Ogestrel-28 is influenced by several factors, including sales volume, pricing strategies, and competition from generic and brand-name alternatives. Here are some key points:

  • Sales Volume: The sales volume of Low-Ogestrel-28 is driven by its prescription rate and user compliance. High efficacy and reliability contribute to consistent sales.
  • Pricing Strategies: The pricing of Low-Ogestrel-28 must balance profitability with competitiveness. Discounts, coupons, and insurance coverage can affect revenue.
  • Generic Competition: The availability of generic versions can erode market share and reduce revenue for the brand-name product[1][5].

Market Trends and Projections

Increasing Demand for Contraceptives

The global demand for contraceptives is expected to increase due to growing awareness about reproductive health and family planning. This trend is likely to benefit Low-Ogestrel-28, assuming it maintains its market position.

Advancements in Contraceptive Technology

Advancements in contraceptive technology, such as the development of new delivery systems or more effective formulations, could impact the market share of Low-Ogestrel-28. Staying competitive through innovation is crucial.

Regulatory Changes

Any changes in regulatory policies, such as updates to safety guidelines or labeling requirements, can influence the market dynamics and financial trajectory of Low-Ogestrel-28.

Challenges and Opportunities

Challenges

  • Safety Concerns: Ongoing monitoring and management of safety concerns related to thrombotic events, liver tumors, and other adverse reactions are critical.
  • Generic Competition: The presence of generic alternatives poses a significant challenge to maintaining market share and revenue.
  • Regulatory Scrutiny: Adherence to evolving regulatory requirements is essential to avoid any negative impact on sales.

Opportunities

  • Expanding User Base: Increasing awareness and access to reproductive health services can expand the user base for Low-Ogestrel-28.
  • Innovation: Investing in research and development to improve the formulation or delivery system can enhance market competitiveness.
  • Global Market: Expanding into new markets, especially in regions with growing demand for contraceptives, can provide new revenue streams.

Key Takeaways

  • Low-Ogestrel-28 operates in a competitive market driven by demand for effective birth control methods.
  • Pricing, safety concerns, and regulatory compliance are critical factors influencing its financial trajectory.
  • The drug faces challenges from generic competition and safety concerns but also has opportunities for growth through innovation and market expansion.
  • Continuous monitoring of market trends and regulatory changes is essential for maintaining a strong market position.

FAQs

1. What are the primary ingredients in Low-Ogestrel-28?

Low-Ogestrel-28 contains the progestational compound norgestrel and the estrogenic compound ethinyl estradiol[2][4].

2. What are the common side effects of Low-Ogestrel-28?

Common side effects include nausea, vomiting, gastrointestinal symptoms, breakthrough bleeding, and changes in menstrual flow. Serious side effects can include thrombophlebitis, arterial thromboembolism, and liver tumors[2][3].

3. How is Low-Ogestrel-28 administered?

The dosage involves taking one white active tablet daily for 21 consecutive days, followed by one peach inert tablet daily for 7 consecutive days[2][5].

4. What are the contraindications for Low-Ogestrel-28?

Contraindications include a high risk of arterial or venous thrombotic diseases, uncontrolled hypertension, benign and malignant liver tumors, and current or past breast cancer[3][4].

5. How does Low-Ogestrel-28 compare to other oral contraceptives?

Low-Ogestrel-28 is a combination oral contraceptive that competes with other similar products and progestin-only pills. It has a specific dosage regimen and associated side effects that differentiate it from other options[1][2].

Cited Sources:

  1. Drugs.com: Low-Ogestrel-28 vs Opill Comparison.
  2. RxList: Low-Ogestrel (Norgestrel and Ethinyl Estradiol Tablets).
  3. DailyMed: LOW-OGESTREL- norgestrel and ethinyl estradiol kit.
  4. Drugs.com: Low-Ogestrel: Package Insert / Prescribing Information.
  5. Drugs.com: Low-Ogestrel Dosage Guide.

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