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, Accord Hlthcare, Appco, Cosette, Novitium Pharma, Rubicon, Granata Bio Corp, and Emd Serono, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for CLOMIPHENE CITRATE

US Patents:	0
Tradenames:	4
Applicants:	8
NDAs:	8
Drug Master File Entries:	15
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	55
Clinical Trials:	179
Patent Applications:	2,309
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
University of Szeged, Hungary	PHASE4
Dunamenti REK Pannon Clinic	PHASE4
Dunamenti REK Istenhegyi IVF Center	PHASE4

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
Cosette	CLOMIPHENE CITRATE	clomiphene citrate	TABLET;ORAL	075528-001	Aug 30, 1999	AB	RX	No	Yes
Rubicon	CLOMIPHENE CITRATE	clomiphene citrate	TABLET;ORAL	216545-001	Nov 12, 2024	AB	RX	No	No

Market Dynamics and Financial Trajectory for Clomiphene Citrate

Last updated: February 19, 2026

Clomiphene citrate is a selective estrogen receptor modulator primarily used for ovulation induction in women and off-label applications like male infertility. The global market for clomiphene citrate is influenced by regulatory status, patent lifecycle, therapeutic demand, and competitive landscape. The drug's revenue potential has fluctuated due to patent expiration, generic availability, and emerging therapies.

Market Overview

The global market for ovulation induction drugs, including clomiphene citrate, was valued at approximately USD 1.2 billion in 2022. Clomiphene accounts for the majority share owing to its low cost and established efficacy. The drug's widespread use in fertility clinics, especially in North America, Europe, and parts of Asia, sustains demand.

Regulatory Landscape

Clomiphene citrate's patent expired in the early 2000s, triggering generic manufacturing and price reductions. Regulatory agencies have approved numerous generic versions, diluting market revenues. However, branded formulations, such as Clomid (produced by Sanofi), maintain market presence through brand recognition and formulation differences.

Production and Supply Chain

Major manufacturers include Teva Pharma, Sun Pharma, Mankind Pharma, and Sandoz. The supply chain benefits from the generic market's competitiveness, maintaining price stability and wide availability.

Key Market Drivers

• Increasing infertility prevalence: Rising infertility rates globally (e.g., WHO estimates 8-12% fertility issues in couples) sustain demand.
• Cost-effectiveness: Clomiphene remains a low-cost alternative to gonadotropins and other advanced fertility treatments.
• Off-label use in male infertility: Growing evidence supports off-label indications, expanding the user base.

Market Challenges

• Patent expiration: Opened market for generics, pressuring prices.
• Emergence of alternatives: Gonadotropins, letrozole, and other agents increasingly compete.
• Safety concerns and side effects: Risks like ovarian hyperstimulation syndrome and multiple pregnancies influence prescribing patterns.

Revenue and Financial Trends

Year	Estimated Global Revenue (USD billion)	Growth Rate	Notes
2018	1.0	3%	Steady demand, generic dominance
2019	1.05	5%	Slight uptick, increased infertility treatments
2020	1.1	4.8%	Pandemic impact reduced elective fertility treatments slightly
2021	1.2	9.1%	Recovery, new markets opening in Asia
2022	1.2	0%	Market stabilization, competition intensifies

Market analysts project a compound annual growth rate (CAGR) of approximately 2-3% over the next five years, driven primarily by emerging markets and off-label indications.

Competitive Landscape and Market Entry

Branded formulations benefit initially from physician preference and marketing, but generics dominate due to lower prices. Entry barriers are low, with multiple manufacturers capable of producing high-quality generic clomiphene citrate.

Financial Outlook and Investment Implications

• Patent expiry and generic proliferation limit profit margins.
• R&D investments are generally limited, focused on optimizing formulations or expanding indications.
• Potential revenue growth hinges on adoption in emerging markets, where fertility treatments grow due to increasing awareness and healthcare access improvements.
• Market consolidation and licensing agreements may influence pricing dynamics.

Regulatory and Policy Impact

• FDA approval for generics provides a broad pathway for manufacturing.
• Intellectual property protections are nonexistent post-patent expiration, fostering price competition.
• Some jurisdictions may impose strict safety regulations for fertility drugs, affecting availability and pricing.

Future Market Trends

• Expansion of off-label uses increases overall market size.
• Technological improvements in fertility treatments may reduce reliance on clomiphene in favor of newer agents.
• Price pressures may lead manufacturers to innovate delivery methods, such as extended-release formulations.

---

Key Takeaways

• Clomiphene citrate remains a core fertility drug, with sales influenced by market expiration of patents and emergence of generics.
• The market is projected to grow slowly at 2-3% annually, driven by increasing infertility rates and expanding indications.
• Competition from alternative therapies and regulatory environments pose challenges.
• Revenue opportunities exist in emerging markets with rising healthcare infrastructure and fertility awareness.
• Innovation focus is limited; most companies rely on price competition and market expansion.

---

FAQs

1. What is the primary use of clomiphene citrate?
It is used to induce ovulation in women with infertility issues and has off-label applications for male infertility.

2. How has patent expiration affected the market?
Patent expiration in the early 2000s facilitated the entry of multiple generic manufacturers, reducing prices and revenue for branded formulations.

3. What are the main challenges in maintaining profitability?
Market saturation, intense generic price competition, and the availability of alternative therapies restrict profit margins.

4. Are there significant regulatory hurdles for new entrants?
Regulatory pathways for generics are well-established, especially in the US and EU, but safety and quality standards must be met.

5. Which regions offer growth potential for clomiphene citrate?
Emerging markets in Asia, Latin America, and Africa have increasing demand due to rising infertility awareness and improvements in healthcare access.

---

References

[1] World Health Organization. (2018). Infertility prevalence estimates.
[2] Statista. (2022). Global fertility drug market size and forecast.
[3] U.S. Food and Drug Administration. (2023). Approved generic drugs.
[4] MarketWatch. (2023). Fertility drugs market analysis.
[5] Reuters. (2022). Generic drug market trends and patent expirations.