FACTREL Drug Patent Profile

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

Factrel is a drug marketed by Hikma and is included in one NDA.

The generic ingredient in FACTREL is gonadorelin hydrochloride. There are seven drug master file entries for this compound. Additional details are available on the gonadorelin hydrochloride profile page.

Summary for FACTREL

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	21
DailyMed Link:	FACTREL at DailyMed

US Patents and Regulatory Information for FACTREL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hikma	FACTREL	gonadorelin hydrochloride	INJECTABLE;INJECTION	018123-001	Sep 30, 1982		DISCN	No	No
Hikma	FACTREL	gonadorelin hydrochloride	INJECTABLE;INJECTION	018123-002	Sep 30, 1982		DISCN	No	No
Hikma	FACTREL	gonadorelin hydrochloride	INJECTABLE;INJECTION	018123-003	Sep 30, 1982		DISCN	No	No

Expired US Patents for FACTREL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Hikma	FACTREL	gonadorelin hydrochloride	INJECTABLE;INJECTION	018123-001	Sep 30, 1982
Hikma	FACTREL	gonadorelin hydrochloride	INJECTABLE;INJECTION	018123-003	Sep 30, 1982
Hikma	FACTREL	gonadorelin hydrochloride	INJECTABLE;INJECTION	018123-002	Sep 30, 1982
Hikma	FACTREL	gonadorelin hydrochloride	INJECTABLE;INJECTION	018123-003	Sep 30, 1982

International Patents for FACTREL

See the table below for patents covering FACTREL around the world.

Country	Patent Number	Title	Estimated Expiration
Germany	2307010
Japan	S6047246
Australia	5150573
Canada	1025441	PROCESS FOR PREPARING THE RELEASING HORMONE OF LUTEINIZING HORMONE (LH) AND OF FOLLICLE STIMULATING HORMONE ), SALTS AND COMPOSITIONS THEREOF, AND INTERMEDIATES THEREFOR

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: FACTREL

Last updated: July 29, 2025

Introduction

FACTREL (gonadorelin injection) is a peptide-based pharmaceutical primarily indicated for diagnostic purposes related to the reproductive system, such as confirming the functional status of the hypothalamic-pituitary-gonadal axis. It has also been used in certain off-label applications, including hormone regulation and fertility treatments. As a drug with a niche but strategically significant market, understanding its current market dynamics and financial trajectory offers valuable insights into its potential growth and competitive positioning.

---

Market Overview

Therapeutic and Diagnostic Domain

FACTREL operates primarily within reproductive health and endocrine diagnostics. The global market for reproductive health drugs is projected to grow at a compound annual growth rate (CAGR) of roughly 7% over the next five years, driven by rising infertility rates, increasing awareness, and expanding access to fertility treatments [1]. While FACTREL’s use is predominantly diagnostic, hormonal therapies and diagnostic agents constitute a segment with steady demand, especially in developed regions like North America and Europe.

Market Segmentation and Key Drivers

• Diagnostic Use: Factrel is critical in assessing pituitary function, particularly in cases of amenorrhea, infertility, or hormonal imbalance. Its role as a diagnostic agent sustains consistent demand within specialized clinics and hospitals.

• Therapeutic Off-label Indications: Although primarily diagnostic, FACTREL has been utilized off-label for stimulating ovulation and hormonal regulation, especially in resource-constrained settings where cost-effective alternatives are sought.

• Market Drivers:

  • Increased diagnosis and treatment of reproductive disorders.
  • Growing prevalence of conditions like polycystic ovary syndrome (PCOS), impacting hormone testing.
  • Aging population with fertility concerns.
  • Technological advances in hormonal testing methodologies.

Competitive Landscape

The competitive environment features several analogs and recombinant gonadotropin products, although FACTREL’s unique peptide structure offers advantages such as biosimilarity and lower manufacturing costs. Major players include licensed generic manufacturers, regional biotech firms, and hospitals, with incumbents often competing on price, manufacturing scale, and clinical efficacy.

Regulatory Environment

Regulatory oversight varies globally; in United States, FACTREL is approved by the FDA for specific diagnostic indications. Regulatory agencies in emerging markets tend to have less stringent pathways, potentially facilitating faster market penetration for generic or biosimilar versions. However, patent protection, if any, must be accounted for, especially as patents near expiry, opening opportunities for biosimilar entrants.

---

Financial Trajectory of FACTREL

Revenue Streams and Market Penetration

The global revenue for hormone diagnostics, including FACTREL, is estimated in the hundreds of millions USD, with a slow but steady growth trajectory. Currently, North America accounts for approximately 45% of this market, propelled by advanced diagnostic infrastructure, followed by Europe and Asia-Pacific regions.

Pricing and Cost Structure

FACTREL’s pricing strategies reflect its niche status. The average wholesale price (AWP) varies but generally remains stable due to limited direct competition. Manufacturing costs for peptide-based injections are relatively low, especially when produced via recombinant methods, supporting healthy margins. Increased competition from biosimilars could exert downward pressure, however.

Emerging Markets and Growth Opportunities

Emerging markets, notably across Asia, Latin America, and Africa, are experiencing increased demand driven by expanding healthcare infrastructure and fertility awareness initiatives. Entry into these markets involves navigating regulatory hurdles but offers significant growth potential, possibly doubling revenues over the next decade if strategic investments are made.

Impact of Patent Expiry and Biosimilar Competition

Patent expiration timelines for FACTREL vary across jurisdictions. Approximately within 5–8 years, the expiration of proprietary rights could foster biosimilar development, leading to price erosion and market share redistribution. Companies investing early in biosimilar development could capture substantial portions of the existing market.

R&D and Lifecycle Management

Ongoing research explores expanded indications, improved formulations, and alternative delivery methods such as sustained-release injections. These innovations could enhance the product lifecycle and broaden application scope, positively influencing future revenues.

---

Market Challenges and Risks

• Regulatory Hurdles: Variability and complexity in gaining approval for biosimilars or new indications may delay growth.
• Pricing Pressures: Increasing competition and government-rationing in healthcare systems could suppress prices.
• Physician and Clinician Acceptance: Adoption depends on clinical efficacy, familiarity, and trust within the medical community.
• Supply Chain Disruptions: Peptide manufacturing is sensitive to raw material scarcity, geopolitical issues, and manufacturing setbacks.

Future Outlook and Investment Considerations

The outlook for FACTREL remains cautiously optimistic, assuming strategic positioning in clinical diagnostics and emerging markets. Investments focusing on biosimilar development, technological innovations (e.g., stable formulations), and targeted marketing could significantly influence its financial trajectory.

---

Key Market Drivers Summary

• Rising global reproductive health needs.
• Expanding diagnostic applications.
• Cost advantages of biosimilars.
• Increasing infrastructure in emerging markets.
• Ongoing R&D initiatives.

---

Conclusion

FACTREL’s market dynamics will likely be shaped by biosimilar competition, regulatory landscapes, and global healthcare access expansion. Financial trajectories hinge upon strategic positioning in emerging markets, technological advancements, and potential off-label indications. The company’s ability to adapt to these factors will determine its market share and revenue growth in the coming years.

---

Key Takeaways

• Growth opportunities exist predominantly in emerging markets and diagnostic applications.
• Patent expiries within 5–8 years could catalyze biosimilar entry, intensifying price competition.
• Strategic investments in R&D and market expansion are vital for maintaining profitability.
• Regulatory environments significantly influence product accessibility and market size.
• Manufacturing efficiencies and cost management will be critical under increasing biosimilar competition.

---

FAQs

1. What are the primary therapeutic applications of FACTREL?

FACTREL is mostly used as a diagnostic agent to assess pituitary function, specifically in evaluating gonadotropin-releasing hormone (GnRH) activity related to reproductive health conditions.

2. How does the competitive landscape affect FACTREL’s market share?

The emergence of biosimilars and generic competitors may reduce pricing power and market share, especially post-patent expiry, unless differentiation through formulation or indications occurs.

3. What regions offer the most significant growth potential for FACTREL?

Emerging markets in Asia, Latin America, and Africa hold substantial growth potential due to expanding healthcare infrastructure and increased fertility diagnoses.

4. What is the outlook for biosimilar competition concerning FACTREL?

Biosimilar development is likely within 5–8 years, potentially leading to price reductions but also offering opportunities for cost-effective alternatives within healthcare systems.

5. How can companies extend the life cycle of FACTREL?

By investing in R&D for new indications, improved formulations, and alternative delivery methods, firms can enhance product differentiation and prolong its market relevance.

---

References

[1] MarketsandMarkets. Reproductive Health Drugs Market Forecast, 2022-2027.