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Last Updated: December 22, 2024

CLOMID Drug Patent Profile


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When do Clomid patents expire, and when can generic versions of Clomid launch?

Clomid is a drug marketed by Sanofi Aventis Us and is included in one NDA.

The generic ingredient in CLOMID 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 Clomid

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

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Recent Clinical Trials for CLOMID

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SponsorPhase
rana alaaeldin aly ibrahim nasrPhase 1/Phase 2
Ain Shams UniversityPhase 1/Phase 2
Johns Hopkins UniversityPhase 1

See all CLOMID clinical trials

US Patents and Regulatory Information for CLOMID

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sanofi Aventis Us CLOMID clomiphene citrate TABLET;ORAL 016131-002 Approved Prior to Jan 1, 1982 DISCN Yes 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

CLOMID Market Analysis and Financial Projection Experimental

Clomiphene Citrate Market Dynamics and Financial Trajectory: A Comprehensive Overview

Introduction to Clomiphene Citrate

Clomiphene citrate, commonly known by the brand name CLOMID, is a non-steroidal fertility medication used primarily to treat infertility in women. It works by stimulating ovulation through the blockade of estrogen receptors in the hypothalamus, leading to the release of follicle-stimulating hormone (FSH) and luteinizing hormone (LH)[3].

Market Size and Growth Projections

The global clomiphene citrate market has been valued at significant figures and is expected to grow substantially over the forecast period. As of 2020, the market was estimated to be valued at US$ 10.02 million and is projected to exhibit a Compounded Annual Growth Rate (CAGR) of 5.4% from 2020 to 2027[1][4].

By 2023, the market size had increased to USD 1,231.82 million, and it is anticipated to reach USD 1,780.04 million by 2030, maintaining the same CAGR of 5.4% during the forecast period of 2024-2031[3][5].

Key Drivers of Market Growth

Several factors are driving the growth of the clomiphene citrate market:

Increasing Prevalence of Infertility

The rising prevalence of infertility issues worldwide is a major driver. Infertility affects a significant portion of the global population, with polycystic ovary syndrome (PCOS) being one of the most common causes of female infertility. In the U.S., for example, PCOS affects 6 to 12% of women of reproductive age[1][4].

Government Initiatives and Awareness

Government initiatives aimed at promoting fertility treatments also play a crucial role. Programs like the Ontario Fertility Program in Canada provide funding for fertility services, increasing access to treatments like clomiphene citrate[4].

Advancements in Healthcare Infrastructure

The expanding healthcare infrastructure in emerging economies, coupled with growing disposable income, has augmented the accessibility of fertility treatments. This is particularly evident in regions like Asia-Pacific, where countries such as China, Japan, and Malaysia are seeing increased demand for fertility treatments[3][4].

Growing Acceptance of Fertility Treatments

The growing acceptance and awareness of assisted reproductive technologies (ART) and other fertility treatments are also driving market growth. Delayed parenthood and lifestyle changes contribute to the rising demand for clomiphene citrate[3].

Market Segmentation

The clomiphene citrate market is segmented based on several criteria:

By Indication

  • PCOS
  • Secondary Amenorrhea
  • Psychogenic Amenorrhea
  • Amenorrhea Galactorrhea Syndrome
  • Others[4]

By Distribution Channel

  • Hospital Pharmacies
  • Retail Pharmacies
  • Online Pharmacies[4]

By Region

  • North America (dominant due to high prevalence of PCOS in the U.S.)
  • Europe
  • Asia-Pacific (emerging as a lucrative market)
  • South America
  • Middle-East and Africa[1][3][4]

Regional Analysis

North America

The North American market, particularly the U.S., holds a dominant position due to the high prevalence of PCOS. Initiatives and awareness campaigns by key players further boost the market in this region[1][4].

Europe

Europe is expected to gain traction with key players implementing strategies to make the medication more affordable. For instance, Sanofi S.A. provides reimbursement for CLOMID under the Pharmaceutical Benefits Scheme (PBS) in Europe and Australia[1].

Asia-Pacific

This region is emerging as a significant market due to rising infertility rates, increasing disposable income, and improving access to healthcare facilities. Countries like China, Japan, and Malaysia are potential markets for clomiphene citrate[3][4].

Competitive Landscape

The market is competitive with several key players:

  • Sanofi S.A.
  • Par Pharmaceutical
  • Merck & Co. Inc.
  • Teva Pharmaceutical Industries Ltd.
  • Cipla Inc.
  • Unichem Laboratories Ltd.
  • Emcure Pharmaceuticals Ltd.
  • Serum Institute of India Pvt. Ltd.
  • Incepta Pharmaceuticals Ltd.
  • Shanghai Trifecta Pharma Co. Ltd.[4]

These companies are engaged in various strategies such as mergers and acquisitions, awareness campaigns, and providing reimbursements to patients to increase their market presence[4].

Impact of COVID-19

The COVID-19 pandemic had a significant impact on the clomiphene citrate market. Women undergoing treatment for infertility or PCOS had to suspend their treatments if they tested positive for COVID-19, as per guidelines from the American Society for Reproductive Medicine (ASRM). However, reports indicated that women who tested positive for COVID-19 could still deliver babies free of the infection[1].

Challenges and Restraints

Despite the positive growth trajectory, the market faces several challenges:

Alternative Treatment Options

The availability of alternative fertility treatments can pose a challenge to the market growth of clomiphene citrate[3].

Potential Side Effects

Clomiphene citrate is associated with potential side effects, which can deter some patients from using it[3].

Regulatory Hurdles

Regulatory challenges in some regions can also hinder market growth. Cultural barriers and varying regulatory environments across different countries can affect the market's expansion[3].

Future Outlook and Research

The market is expected to continue its expansion with ongoing research and development activities focused on improving the efficacy and safety profile of clomiphene citrate. Key players are investing in enhancing treatment outcomes and reducing side effects, which will further propel market growth[3].

Key Takeaways

  • The global clomiphene citrate market is valued at USD 1,231.82 million in 2023 and is projected to reach USD 1,780.04 million by 2030.
  • The market is expected to grow at a CAGR of 5.4% during the forecast period.
  • North America, particularly the U.S., holds a dominant position due to the high prevalence of PCOS.
  • Asia-Pacific is an emerging lucrative market driven by rising infertility rates and improving healthcare infrastructure.
  • Key players are focused on awareness campaigns, mergers and acquisitions, and providing reimbursements to patients.

FAQs

What is the primary use of clomiphene citrate?

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

How does clomiphene citrate work?

Clomiphene citrate works by blocking estrogen receptors in the hypothalamus, leading to the release of FSH and LH, which are essential for ovulation.

What are the key drivers of the clomiphene citrate market?

Key drivers include the increasing prevalence of infertility, government initiatives, advancements in healthcare infrastructure, and growing acceptance of fertility treatments.

Which region is expected to be a significant market for clomiphene citrate?

Asia-Pacific is emerging as a significant market due to rising infertility rates and improving access to healthcare facilities.

What are the potential challenges to the growth of the clomiphene citrate market?

Challenges include the availability of alternative treatment options, potential side effects, and regulatory hurdles in some regions.

Sources

  1. Coherent Market Insights, "Clomiphene Citrate Market Size, Trends And Forecast To 2027".
  2. Market Research Intellect, "Global Clomiphene Citrate Market Size, Trends and Projections".
  3. Reanin, "Clomiphene Citrate Market | Growth | Size | Trends and Forecast".
  4. Business Wire, "Global Clomiphene Citrate Market to Surpass US$ 14.51 Million by 2027, Says Coherent Market Insights".
  5. Verified Market Research, "Clomiphene Citrate Market Size, Share, Scope, Growth & Forecast".

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