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Last Updated: December 23, 2024

ELURYNG Drug Patent Profile


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

Eluryng is a drug marketed by Amneal and is included in one NDA.

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

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Summary for ELURYNG
Drug patent expirations by year for ELURYNG
Drug Prices for ELURYNG

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Pharmacology for ELURYNG
Drug ClassEstrogen
Progestin
Mechanism of ActionEstrogen Receptor Agonists

US Patents and Regulatory Information for ELURYNG

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Amneal ELURYNG ethinyl estradiol; etonogestrel RING;VAGINAL 210830-001 Dec 11, 2019 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

ELURYNG Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for EluRyng

Introduction to EluRyng

EluRyng, developed by Amneal Pharmaceuticals, is the first generic version of the popular birth control device NuvaRing. It is an etonogestrel/ethinyl estradiol vaginal ring designed to prevent pregnancy. The FDA approved EluRyng through an Abbreviated New Drug Application (ANDA) in December 2019, marking a significant milestone in the pharmaceutical industry[1][4].

Market Approval and Launch

The approval of EluRyng was a result of Amneal's deep scientific and regulatory capabilities, as well as its ability to overcome the complex formulation and manufacturing requirements associated with this product. This approval is part of Amneal's strategy to launch 15 new, complex products over the next 18 to 24 months following the approval[1][4].

Market Size and Potential

The market for NuvaRing, and by extension EluRng, is substantial. For the 12 months ending October 31, 2019, NuvaRing generated approximately $967 million in U.S. sales. This figure indicates a large and established market for vaginal ring contraceptives, providing a significant opportunity for EluRyng to capture market share[1][4].

Pricing and Cost Considerations

The cost of EluRyng is notably lower than its brand-name counterpart. A supply of three EluRyng vaginal rings costs around $155, which is significantly cheaper than the brand-name NuvaRing. This pricing makes EluRyng an attractive option for consumers seeking affordable birth control solutions[2].

Impact on Consumers

For consumers, the introduction of EluRyng offers several benefits:

  • Affordability: The generic version is priced lower than NuvaRing, making it more accessible to a wider audience.
  • Convenience: The product is available through various pharmacies and can be obtained using discount cards, further reducing the cost[2].
  • Usage: The etonogestrel/ethinyl estradiol vaginal ring must be inserted into the vagina for 3 weeks and then removed for 1 week before a new ring is inserted, providing a convenient and effective birth control method[4].

Competitive Landscape

The pharmaceutical industry, particularly the market for contraceptives, is highly competitive. The entry of EluRyng into this market introduces a new player that can challenge the dominance of brand-name products like NuvaRing. Amneal’s ability to develop and commercialize complex generic products positions the company to compete effectively against both brand and generic drug product companies[1].

Financial Trajectory

The financial trajectory for EluRyng is promising due to several factors:

  • Market Demand: The existing demand for NuvaRing translates into a ready market for EluRyng, ensuring a strong sales potential.
  • Cost Savings: The lower production and development costs associated with generic drugs allow for higher profit margins compared to brand-name drugs.
  • Pipeline Opportunities: Amneal’s commitment to launching additional high-value products in the near future suggests a robust pipeline that can drive continued growth and value creation for shareholders[1].

Regulatory and Legal Considerations

The approval of EluRyng was subject to rigorous regulatory scrutiny, and its commercialization is influenced by various regulatory and legal factors. These include the impact of healthcare reform, changes in coverage and reimbursement levels by governmental authorities, and legal efforts by brand competitors to deter competition from generic alternatives[1].

Market Growth and Projections

The introduction of EluRyng is expected to contribute to the overall growth of the contraceptive market. As more consumers opt for generic versions due to their affordability, the market share of EluRyng is likely to increase. This trend aligns with the broader shift towards generic medications, driven by cost considerations and the expiration of patents for brand-name drugs[5].

Challenges and Risks

Despite the positive outlook, there are several challenges and risks associated with the commercial success of EluRyng:

  • Competition: The pharmaceutical industry is highly competitive, with both brand and generic companies vying for market share.
  • Regulatory Changes: Changes in healthcare policies and reimbursement levels can impact the profitability of EluRyng.
  • Product Liability: As with any pharmaceutical product, there is a risk of product liability claims that could affect the company’s financial performance[1].

Conclusion

The market dynamics and financial trajectory for EluRyng are favorable, driven by its approval as the first generic version of NuvaRing, significant market demand, and competitive pricing. As Amneal continues to develop and commercialize complex generic products, the company is well-positioned to capture a substantial share of the contraceptive market and drive meaningful growth and value creation.

Key Takeaways

  • First Generic Version: EluRyng is the first generic version of NuvaRing, approved by the FDA in December 2019.
  • Market Potential: The product has significant market potential, given the $967 million in U.S. sales of NuvaRing in 2019.
  • Affordability: EluRyng is priced lower than NuvaRing, making it more accessible to consumers.
  • Competitive Landscape: The entry of EluRyng introduces competition in the contraceptive market, challenging brand-name dominance.
  • Financial Trajectory: The financial outlook is positive due to strong market demand, cost savings, and a robust product pipeline.

FAQs

Q: What is EluRyng and how does it differ from NuvaRing?

A: EluRyng is the first generic version of NuvaRing, a vaginal ring contraceptive. It contains the same active ingredients (etonogestrel and ethinyl estradiol) but is priced lower than the brand-name product.

Q: How much does EluRyng cost?

A: The cost of EluRyng is around $155 for a supply of three vaginal rings, depending on the pharmacy.

Q: What are the benefits of using EluRyng?

A: EluRyng offers affordability, convenience, and an effective birth control method, similar to NuvaRing but at a lower cost.

Q: How does the approval of EluRyng impact Amneal Pharmaceuticals?

A: The approval of EluRyng underscores Amneal’s capabilities in developing complex generic products and positions the company for significant growth and value creation.

Q: What are the potential risks associated with EluRyng?

A: The risks include competition from brand and generic companies, regulatory changes, and potential product liability claims.

Sources

  1. Amneal Receives Abbreviated New Drug Application Approval for EluRyng, the First Generic NuvaRing. Business Wire, December 12, 2019.
  2. EluRyng Prices, Coupons, Copay Cards & Patient Assistance. Drugs.com.
  3. Global Drug-Eluting Stents Strategic Research Report 2024-2030. GlobeNewswire, April 30, 2024.
  4. FDA Approves First Generic Version of NuvaRing. Pharmacy Times, December 13, 2019.
  5. NuvaRing cost 2024: Coupons and more. MedicalNewsToday, December 11, 2023.

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