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Last Updated: December 22, 2024

FYREMADEL Drug Patent Profile


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

Fyremadel is a drug marketed by Sun Pharm and is included in one NDA.

The generic ingredient in FYREMADEL is ganirelix acetate. There are four drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the ganirelix acetate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Fyremadel

A generic version of FYREMADEL was approved as ganirelix acetate by ORGANON USA ORGANON on July 29th, 1999.

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

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US Patents and Regulatory Information for FYREMADEL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharm FYREMADEL ganirelix acetate INJECTABLE;INJECTION 204246-001 Nov 30, 2018 AP 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

FYREMADEL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Fyremadel (Ganirelix Acetate Injection)

Introduction to Fyremadel

Fyremadel, known generically as ganirelix acetate injection, is a synthetic decapeptide used in fertility treatments to inhibit premature luteinizing hormone (LH) surges in women. This medication is crucial for women undergoing assisted reproductive technologies like in vitro fertilization (IVF)[3].

Market Positioning

Reproductive Health Portfolio

Ferring Pharmaceuticals, the company behind Fyremadel, has a robust reproductive health portfolio. The acquisition of the U.S. commercialization rights for a generic version of Ganirelix Acetate Injection from Sun Pharmaceutical Industries Ltd. has strengthened Ferring's position in the reproductive medicine market. This addition complements other products like MENOPUR, NOVAREL, and ENDOMETRIN, making Ferring a leader in this segment[4].

Market Demand

Fertility Treatment Trends

The demand for fertility treatments, including medications like Fyremadel, is increasing due to rising awareness and the growing number of women delaying childbearing. This trend is driven by factors such as lifestyle changes, career priorities, and advancements in reproductive technology.

Competitive Landscape

The fertility treatment market is competitive, with several pharmaceutical companies offering various products. However, Ferring's comprehensive portfolio and the exclusivity of the generic Ganirelix Acetate Injection in the U.S. market provide a competitive edge.

Financial Performance

Revenue Streams

The revenue generated from Fyremadel is part of Ferring's broader reproductive health segment. While specific financial figures for Fyremadel are not publicly disclosed, the overall performance of Ferring's reproductive health portfolio indicates a significant revenue stream.

Cost and Pricing

The cost of Fyremadel, like other fertility medications, can be substantial. However, the generic version acquired by Ferring is likely to offer a more affordable option compared to branded alternatives, potentially increasing market share and revenue.

Regulatory and Market Factors

Generic Market Impact

The introduction of a generic version of Ganirelix Acetate Injection can significantly impact the market. Generic drugs typically offer lower prices, which can increase accessibility and market penetration. This is evident from the historical financial results and rate reviews, where generic drugs are often highlighted for their cost-effectiveness[5].

Insurance and Reimbursement

Insurance coverage and reimbursement policies play a crucial role in the financial trajectory of Fyremadel. Changes in insurance regulations and the inclusion of fertility treatments in health plans can influence the demand and revenue generated from the drug.

Future Outlook

Market Growth

The fertility treatment market is expected to grow, driven by increasing demand and advancements in technology. Ferring's commitment to reproductive health and its comprehensive portfolio position the company well for continued growth.

Competitive Strategies

To maintain market dominance, Ferring may focus on further expanding its reproductive health portfolio, investing in research and development, and enhancing its commercialization strategies. Partnerships and collaborations, similar to the one with INVO Bioscience Inc. for the INVOcellâ„¢ Intravaginal Culture System, can also be strategic moves[4].

Challenges and Opportunities

Regulatory Challenges

Changes in regulatory environments, such as those related to the Affordable Care Act or other healthcare reforms, can impact the market dynamics of Fyremadel. Companies must adapt to these changes to maintain market share.

Technological Advancements

Advancements in reproductive technology offer opportunities for Ferring to innovate and expand its product offerings. Investing in research and development can help the company stay ahead in the competitive market.

Key Takeaways

  • Market Position: Fyremadel is part of Ferring's robust reproductive health portfolio, positioning the company as a leader in fertility treatments.
  • Demand Trends: Increasing demand for fertility treatments driven by lifestyle changes and technological advancements.
  • Financial Performance: Revenue generated from Fyremadel contributes to Ferring's overall reproductive health segment, with potential for growth through generic offerings.
  • Regulatory Factors: Generic market impact and insurance reimbursement policies significantly influence the financial trajectory.
  • Future Outlook: Expected market growth driven by demand and technological advancements, with strategic focus on portfolio expansion and innovation.

FAQs

1. What is Fyremadel used for?

Fyremadel (ganirelix acetate injection) is used to inhibit premature luteinizing hormone (LH) surges in women undergoing fertility treatments like IVF.

2. Who is the primary manufacturer of Fyremadel in the U.S.?

Ferring Pharmaceuticals holds the exclusive U.S. commercialization rights for a generic version of Ganirelix Acetate Injection.

3. How does the generic version of Fyremadel impact the market?

The generic version offers a more affordable option, increasing accessibility and potentially increasing market share and revenue.

4. What are the key factors influencing the financial performance of Fyremadel?

Key factors include market demand, regulatory changes, insurance reimbursement policies, and competitive strategies.

5. What is the future outlook for Fyremadel in the fertility treatment market?

The market is expected to grow driven by increasing demand and technological advancements, with Ferring well-positioned for continued growth through its comprehensive portfolio and innovative strategies.

Cited Sources

  1. Ferring Pharmaceuticals adds two products to its robust reproductive health portfolio in the U.S. - Ferring USA.
  2. Fyremadel (Ganirelix for Injection): Side Effects, Uses - RxList.
  3. BCVT-133971481 - Rate Review - Vermont.gov.

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