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Last Updated: December 22, 2024

ESTARYLLA Drug Patent Profile


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Which patents cover Estarylla, and what generic alternatives are available?

Estarylla is a drug marketed by Xiromed and is included in one NDA.

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

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US Patents and Regulatory Information for ESTARYLLA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Xiromed ESTARYLLA ethinyl estradiol; norgestimate TABLET;ORAL-28 090794-001 Jan 30, 2013 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

ESTARYLLA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Estarylla

Introduction

Estarylla, a combination oral contraceptive containing norgestimate and ethinyl estradiol, is a widely used medication for birth control and the treatment of moderate acne. Understanding its market dynamics and financial trajectory is crucial for pharmaceutical companies, investors, and healthcare providers.

Market Indications and Usage

Estarylla is indicated for use by females of reproductive potential to prevent pregnancy and to treat moderate acne vulgaris in females at least 15 years of age who have achieved menarche and have no known contraindications to oral contraceptive therapy[3].

User Reviews and Satisfaction

User reviews of Estarylla are mixed, reflecting the varied experiences of individuals. On Drugs.com, Estarylla has an average rating of 3.7 out of 10 from over 510 reviews, with 22% of reviewers reporting a positive experience and 64% reporting negative experiences. Positive reviews highlight improvements in energy, reduction in menstrual cramps, and clear skin, while negative reviews often mention side effects such as anxiety, anger, bloating, and decreased sex drive[1][4].

Market Competition

The oral contraceptive market is highly competitive, with numerous brands and generics available. Estarylla competes with other norgestimate and ethinyl estradiol combinations like Sprintec and Mononessa. The similarity in active ingredients but differences in formulation and brand can lead to varying user experiences, as seen in reviews where users switched from one brand to another and experienced different side effects[1][4].

Regulatory and Safety Considerations

Estarylla is subject to various regulatory and safety considerations. It is contraindicated in women with liver disease, benign and malignant liver tumors, and breast cancer. There are also warnings about the risk of liver enzyme elevations with concomitant hepatitis C treatment and the potential for an increased risk of cervical cancer and hepatocellular carcinoma in long-term users[3].

Financial Trajectory

The financial performance of Estarylla is influenced by several factors, including market demand, competition, and regulatory compliance.

Sales and Market Share

Estarylla, being a generic version of Ortho Tri-Cyclen, benefits from the established market presence of its branded counterpart. However, its sales can be affected by the availability of other generics and branded alternatives. The mixed user reviews may also impact its market share, as some users may opt for other oral contraceptives based on their experiences.

Recalls and Compliance

In 2013, Sandoz US announced a voluntary nationwide recall of one lot of Estarylla tablets due to quality control issues, which could have temporarily impacted sales and revenue. Ensuring compliance with regulatory standards is crucial for maintaining market trust and financial stability[5].

Pricing and Accessibility

The pricing of Estarylla is generally competitive with other generic oral contraceptives. However, variations in insurance coverage and out-of-pocket costs can influence its accessibility and market demand.

Clinical Studies and Efficacy

Clinical studies have shown that Estarylla is effective in preventing pregnancy and treating moderate acne. The frequency and duration of breakthrough bleeding and/or spotting were assessed in clinical trials, indicating that while some women experience these issues, the overall efficacy of the medication is maintained[3].

Consumer Behavior and Preferences

Consumer behavior plays a significant role in the market dynamics of Estarylla. Users often rely on reviews and personal recommendations when choosing a birth control method. The varied experiences reported by users highlight the importance of individual tolerance and the need for personalized healthcare advice.

Healthcare Provider Influence

Healthcare providers significantly influence the prescription rates of Estarylla. Their recommendations are based on clinical guidelines, patient history, and the specific needs of each patient. Providers must weigh the benefits against the potential side effects when prescribing this medication.

Future Outlook

The future outlook for Estarylla depends on several factors, including ongoing clinical research, regulatory compliance, and market competition. As the healthcare landscape evolves, there may be increased focus on personalized medicine, which could impact the prescription rates of Estarylla and other oral contraceptives.

Key Takeaways

  • Mixed User Reviews: Estarylla has mixed user reviews, with some users experiencing significant side effects while others report positive outcomes.
  • Regulatory Considerations: The medication is subject to various contraindications and warnings, particularly related to liver and breast health.
  • Market Competition: Estarylla competes in a highly competitive oral contraceptive market with both branded and generic alternatives.
  • Financial Stability: The financial performance is influenced by sales, market share, and regulatory compliance.
  • Clinical Efficacy: Clinical studies confirm the efficacy of Estarylla in preventing pregnancy and treating acne, despite some users experiencing breakthrough bleeding or spotting.

FAQs

  1. What are the primary indications for Estarylla? Estarylla is indicated for the prevention of pregnancy and the treatment of moderate acne vulgaris in females at least 15 years of age who have achieved menarche and have no known contraindications to oral contraceptive therapy[3].

  2. What are common side effects reported by users of Estarylla? Common side effects include anxiety, anger, bloating, decreased sex drive, nausea, headaches, and mood swings. However, some users report positive effects such as increased energy, reduced menstrual cramps, and clear skin[1][4].

  3. Is Estarylla contraindicated in any medical conditions? Yes, Estarylla is contraindicated in women with liver disease, benign and malignant liver tumors, and breast cancer. It is also contraindicated in women with severe (decompensated) cirrhosis of the liver and those undergoing certain hepatitis C treatments[3].

  4. How does Estarylla compare to other oral contraceptives? Estarylla is similar to other norgestimate and ethinyl estradiol combinations like Sprintec and Mononessa but may have different formulations and brand-specific effects. User experiences can vary significantly between these medications[1][4].

  5. Has Estarylla been subject to any recalls? Yes, in 2013, Sandoz US announced a voluntary nationwide recall of one lot of Estarylla tablets due to quality control issues[5].

Sources

  1. https://www.drugs.com/comments/ethinyl-estradiol-norgestimate/estarylla-for-contraception.html
  2. https://simplywall.st/stocks/us/pharmaceuticals-biotech/nasdaq-esla/estrella-immunopharma/health
  3. https://www.drugs.com/pro/tri-estarylla.html
  4. https://www.drugs.com/comments/ethinyl-estradiol-norgestimate/estarylla.html
  5. https://www.fiercepharma.com/pharma/sandoz-us-announces-voluntary-nationwide-recall-of-one-lot-of-estarylla%C2%AE

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