CLOMIPHENE CITRATE - Generic Drug Details

What are the generic drug sources for clomiphene citrate and what is the scope of patent protection?

Clomiphene citrate is the generic ingredient in four branded drugs marketed by Sanofi Aventis Us, Cosette, Granata Bio, and Emd Serono, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

There are fifteen drug master file entries for clomiphene citrate. Five suppliers are listed for this compound.

Summary for CLOMIPHENE CITRATE

US Patents:	0
Tradenames:	4
Applicants:	4
NDAs:	4
Drug Master File Entries:	15
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	166
Clinical Trials:	171
Patent Applications:	847
Drug Prices:	Drug price trends for CLOMIPHENE CITRATE
What excipients (inactive ingredients) are in CLOMIPHENE CITRATE?	CLOMIPHENE CITRATE excipients list
DailyMed Link:	CLOMIPHENE CITRATE at DailyMed

See drug prices for CLOMIPHENE CITRATE

Recent Clinical Trials for CLOMIPHENE CITRATE

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

Sponsor	Phase
Batterjee Medical College	Phase 4
Bezmialem Vakif University	N/A
University of Illinois at Chicago	Phase 3

See all CLOMIPHENE CITRATE clinical trials

Pharmacology for CLOMIPHENE CITRATE

Drug Class	Estrogen Agonist/Antagonist
Mechanism of Action	Selective Estrogen Receptor Modulators

Medical Subject Heading (MeSH) Categories for CLOMIPHENE CITRATE

Estrogen Antagonists

Fertility Agents, Female

Selective Estrogen Receptor Modulators

US Patents and Regulatory Information for CLOMIPHENE CITRATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Emd Serono	SEROPHENE	clomiphene citrate	TABLET;ORAL	018361-001	Mar 22, 1982		DISCN	No	No
Sanofi Aventis Us	CLOMID	clomiphene citrate	TABLET;ORAL	016131-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Granata Bio	MILOPHENE	clomiphene citrate	TABLET;ORAL	072196-001	Dec 20, 1988		DISCN	No	No
Cosette	CLOMIPHENE CITRATE	clomiphene citrate	TABLET;ORAL	075528-001	Aug 30, 1999		RX	No	Yes

CLOMIPHENE CITRATE Market Analysis and Financial Projection Experimental

Clomiphene Citrate Market Dynamics and Financial Trajectory

Market Overview

Clomiphene citrate, commonly known by the brand name Clomid, is a non-steroidal fertility medication used primarily for ovulation induction in women with infertility issues. The global market for clomiphene citrate has been experiencing significant growth, driven by several key factors.

Market Size and Growth Projections

As of 2023, the global clomiphene citrate market was valued at USD 1,231.82 million. It is projected to grow to USD 1,780.04 million by 2030, with a Compounded Annual Growth Rate (CAGR) of 5.4%[3].

Drivers of Market Growth

Increasing Infertility Rates

The rising prevalence of infertility worldwide is a major driver of the clomiphene citrate market. Factors such as delayed parenthood, lifestyle changes, and increasing awareness about fertility treatments contribute to this trend[3][4].

Advancements in Assisted Reproductive Technologies (ART)

Advancements in ART and the growing acceptance of fertility treatments are boosting the demand for clomiphene citrate. This includes improvements in healthcare infrastructure and the expansion of fertility clinics globally[3][4].

Government Initiatives and Regulatory Support

Favorable government initiatives aimed at promoting fertility treatments and improving access to reproductive healthcare further propel market expansion. These initiatives help in increasing the accessibility and affordability of fertility treatments[3].

Regional Analysis

Developed Markets

Regions such as North America and Europe account for a significant share of the market, driven by higher healthcare spending and greater awareness about fertility treatments. These markets are characterized by well-established healthcare infrastructures and high demand for fertility services[4].

Emerging Markets

The Asia Pacific, Latin America, and Middle East regions present lucrative growth opportunities due to rising infertility rates, increasing disposable income, and improving access to healthcare facilities. These regions are witnessing a surge in demand for assisted reproductive technologies, further boosting market growth[3][4].

Market Dynamics

Drivers

• Increasing Infertility Rates: Rising infertility issues globally drive the demand for clomiphene citrate.
• Advancements in ART: Improvements in reproductive technologies enhance the effectiveness and appeal of fertility treatments.
• Government Support: Favorable government initiatives promote fertility treatments and improve access to reproductive healthcare[3][4].

Restraints

• Regulatory Challenges: Regulatory complexities and varying regulatory frameworks across regions can pose constraints to market growth.
• Cultural Barriers: Cultural attitudes toward fertility treatments can affect market penetration in certain regions.
• Safety Concerns: Potential side effects and adverse perinatal outcomes associated with clomiphene citrate use may impact market growth[3][5].

Opportunities

• Untapped Markets: Regions like the Middle East, Africa, and Latin America offer untapped opportunities due to evolving healthcare landscapes and expanding fertility clinics.
• Research and Development: Continuous R&D activities focused on enhancing treatment outcomes and reducing side effects can drive market expansion[3][4].

Challenges

• Alternative Treatments: The emergence of alternative fertility treatments may pose competition to clomiphene citrate.
• Safety and Efficacy: Ensuring the safety and efficacy of clomiphene citrate, especially in terms of fetal development and pregnancy outcomes, is a critical challenge[5].

Competitive Landscape

The clomiphene citrate market is highly competitive, with several pharmaceutical companies offering both generic and branded formulations. Key players focus on product differentiation, market expansion, and strategic collaborations to gain a competitive edge. Investments in R&D to develop novel drug delivery formulations and improve treatment outcomes are also a priority[4].

Cost and Affordability

Clomiphene citrate is generally considered affordable, with costs ranging from about $10 to $100 per cycle, depending on the dose and whether a brand name or generic version is used. The average cost for a cycle of Clomid is approximately $40, while generic clomiphene citrate can cost around $15 per cycle[2].

Future Outlook

The future outlook for the clomiphene citrate market is promising, driven by increasing infertility rates, technological advancements in reproductive medicine, and expanding access to fertility treatments worldwide. Despite regulatory and safety challenges, strategic initiatives focused on innovation, patient-centric care, and regulatory compliance are expected to drive market growth and differentiation[4].

Key Takeaways

• The global clomiphene citrate market is projected to grow significantly, driven by increasing infertility rates and advancements in ART.
• Emerging markets in Asia Pacific, Latin America, and the Middle East offer lucrative growth opportunities.
• Regulatory challenges and safety concerns must be addressed to ensure sustainable market growth.
• Continuous R&D and strategic collaborations are crucial for market players to maintain competitiveness.
• The market is expected to expand due to favorable government initiatives and improving healthcare infrastructure.

FAQs

Q: What is the current market size of the global clomiphene citrate market?

A: As of 2023, the global clomiphene citrate market was valued at USD 1,231.82 million[3].

Q: What is the projected growth rate of the clomiphene citrate market?

A: The market is expected to grow at a CAGR of 5.4% from 2023 to 2030[3].

Q: What are the main drivers of the clomiphene citrate market?

A: The main drivers include increasing infertility rates, advancements in ART, and favorable government initiatives[3][4].

Q: Which regions offer the most promising growth opportunities for clomiphene citrate?

A: Emerging markets in Asia Pacific, Latin America, and the Middle East offer significant growth prospects due to rising infertility rates and improving healthcare access[3][4].

Q: What are the potential challenges facing the clomiphene citrate market?

A: Regulatory challenges, cultural barriers, and safety concerns related to adverse perinatal outcomes are potential challenges[3][5].

Sources

1. Market Research Intellect: Global Clomiphene Citrate Market Size, Trends and Projections.
2. Advanced Fertility: Clomid Fertility Drug Treatment Protocols, Clomiphene Citrate.
3. Reanin: Clomiphene Citrate Market | Growth | Size | Trends and Forecast.
4. MarkWide Research: Clomiphene Citrate Market 2024-2032 | Size, Share, Growth.
5. Oxford Academic: Clomiphene Citrate Administered in Periconception Phase Causes ...