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Last Updated: December 22, 2024

MILOPHENE Drug Patent Profile


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Which patents cover Milophene, and when can generic versions of Milophene launch?

Milophene is a drug marketed by Granata Bio and is included in one NDA.

The generic ingredient in MILOPHENE is clomiphene citrate. There are sixteen drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the clomiphene citrate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Milophene

A generic version of MILOPHENE was approved as clomiphene citrate by COSETTE on August 30th, 1999.

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Summary for MILOPHENE
Drug patent expirations by year for MILOPHENE
Recent Clinical Trials for MILOPHENE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Weill Medical College of Cornell UniversityPhase 2

See all MILOPHENE clinical trials

US Patents and Regulatory Information for MILOPHENE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Granata Bio MILOPHENE clomiphene citrate TABLET;ORAL 072196-001 Dec 20, 1988 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

MILOPHENE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Clomiphene Citrate (MILOPHENE)

Introduction to Clomiphene Citrate (MILOPHENE)

Clomiphene citrate, commonly known by the brand name Milophene among others, is a medication primarily used to treat infertility in women. It belongs to the class of selective estrogen receptor modulators (SERMs) and works by stimulating the release of hormones that cause ovulation.

Market Size and Forecast

The Clomiphene Citrate market has been experiencing steady growth, driven by several key factors. As of 2023, the market size was valued at USD 1,231.82 million. It is projected to reach USD 1,780.04 million by 2031, growing at a compound annual growth rate (CAGR) of 5.4% during the forecast period of 2024-2031[1].

Regional Market Dynamics

North America

North America is a significant region for Clomiphene Citrate sales, driven by high healthcare expenditure, advanced healthcare infrastructure, and a higher prevalence of infertility treatments. The region's mature healthcare system and high awareness about fertility treatments contribute to its dominant market position[1].

Europe

Europe follows closely behind North America, with substantial market growth fueled by rising awareness about fertility treatments, supportive healthcare policies, and increasing infertility rates due to lifestyle changes. European countries have robust healthcare systems and a strong focus on reproductive health, which supports the market's expansion[1].

Asia-Pacific

The Asia-Pacific region exhibits significant market potential and growth, propelled by growing awareness, economic development, and a booming population. Improving healthcare facilities and increasing adoption of modern medical treatments in this region are key drivers of the market[1].

Latin America

Latin America's market is burgeoning, supported by increasing government initiatives and improving healthcare access. Although the growth is typically slower compared to North America and Europe, the region shows promising signs of expansion[1].

Middle East & Africa

The Middle East & Africa region shows steady market development, powered by improving healthcare infrastructures, rising awareness regarding fertility issues, and increasing adoption of modern medical treatments. This region, while growing at a slower pace, is an important segment for future market expansion[1].

Drivers of Market Growth

Increasing Prevalence of Infertility

The global increase in infertility rates, partly due to lifestyle changes and delayed childbearing, is a major driver of the Clomiphene Citrate market. As more individuals seek fertility treatments, the demand for Clomiphene Citrate and other infertility drugs is expected to rise[4].

Advancements in Healthcare Infrastructure

Improvements in healthcare infrastructure, particularly in emerging markets, enhance the accessibility and quality of fertility treatments. This infrastructure development is crucial for the growth of the Clomiphene Citrate market[1].

Regulatory Support and Awareness

Supportive healthcare policies and increasing awareness about fertility treatments play a significant role in driving the market. Regulatory approvals and guidelines that facilitate the use of Clomiphene Citrate also contribute to its market growth[1].

Economic Factors

Economic development in various regions, especially in the Asia-Pacific, is another key factor. As economies grow, so does the ability of individuals to afford healthcare services, including fertility treatments[1].

Competitive Landscape

The infertility drugs market, which includes Clomiphene Citrate, is highly competitive with several players. The market is segmented by drug class, with SERMs like Clomiphene Citrate being a significant segment. Other drug classes include gonadotropins, aromatase inhibitors, and dopamine agonists[4].

Distribution Channels

The distribution of Clomiphene Citrate is primarily through hospital pharmacies, specialty and retail pharmacies, and online pharmacies. The ease of access through these channels contributes to the market's growth[4].

End-User Analysis

Clomiphene Citrate is predominantly used for treating infertility in women. However, the broader infertility drugs market also caters to male infertility treatments. The end-user segment is divided between men and women, with women being the primary users of Clomiphene Citrate[4].

Financial Trajectory

The financial trajectory of the Clomiphene Citrate market is positive, with a projected CAGR of 5.4% from 2024 to 2031. Here are some key financial highlights:

  • Market Size in 2023: USD 1,231.82 million
  • Projected Market Size in 2031: USD 1,780.04 million
  • CAGR: 5.4% from 2024 to 2031[1].

Challenges and Opportunities

Challenges

Despite the growth, the market faces challenges such as side effects associated with Clomiphene Citrate, competition from other fertility treatments, and regulatory hurdles. Additionally, the market's growth can be impacted by economic downturns and changes in healthcare policies[1].

Opportunities

The increasing awareness about fertility treatments and the growing demand for infertility drugs present significant opportunities. Emerging markets, particularly in the Asia-Pacific and Latin America regions, offer untapped potential for market expansion. Advances in medical technology and the development of new therapeutic targets also provide opportunities for innovation and growth[1].

Key Takeaways

  • The Clomiphene Citrate market is expected to grow from USD 1,231.82 million in 2023 to USD 1,780.04 million by 2031.
  • North America and Europe are the leading regions, driven by advanced healthcare infrastructure and high awareness about fertility treatments.
  • The Asia-Pacific region shows significant potential due to economic development and growing awareness.
  • Increasing prevalence of infertility and improvements in healthcare infrastructure are key drivers of the market.
  • The market faces challenges such as side effects and competition but offers opportunities in emerging markets and technological advancements.

FAQs

What is Clomiphene Citrate used for?

Clomiphene Citrate is primarily used to treat infertility in women by stimulating ovulation.

What is the projected market size of Clomiphene Citrate by 2031?

The Clomiphene Citrate market is projected to reach USD 1,780.04 million by 2031.

What is the CAGR of the Clomiphene Citrate market from 2024 to 2031?

The CAGR of the Clomiphene Citrate market is 5.4% from 2024 to 2031.

Which regions are the key markets for Clomiphene Citrate?

North America, Europe, and the Asia-Pacific are the key regions for the Clomiphene Citrate market.

What are the main drivers of the Clomiphene Citrate market?

The main drivers include increasing prevalence of infertility, advancements in healthcare infrastructure, regulatory support, and economic development.

Sources

  1. Verified Market Research: Clomiphene Citrate Market Size, Share, Scope, Growth & Forecast.
  2. FDA: QueryResult - FDA (Not directly relevant but provides context on pharmaceutical market dynamics).
  3. GlobeNewswire: Multiple Sclerosis Drugs Market Outlook and Strategic Business Report 2024-2030.
  4. Grand View Research: Infertility Drugs Market Size, Share & Growth Report, 2030.

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