FACTREL Drug Patent Profile

When do Factrel patents expire, 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	3,947,569
Hikma	FACTREL	gonadorelin hydrochloride	INJECTABLE;INJECTION	018123-003	Sep 30, 1982	4,110,438
Hikma	FACTREL	gonadorelin hydrochloride	INJECTABLE;INJECTION	018123-001	Sep 30, 1982	4,110,438
Hikma	FACTREL	gonadorelin hydrochloride	INJECTABLE;INJECTION	018123-003	Sep 30, 1982	3,947,569
Hikma	FACTREL	gonadorelin hydrochloride	INJECTABLE;INJECTION	018123-002	Sep 30, 1982	4,110,438
Hikma	FACTREL	gonadorelin hydrochloride	INJECTABLE;INJECTION	018123-002	Sep 30, 1982	3,947,569

International Patents for FACTREL

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

Country	Patent Number	Title	Estimated Expiration
Belgium	865156
Japan	S4886868
France	2181730
Australia	476785
Israel	41313
United Kingdom	1425511
Japan	S53115808	DEPRESSION TREATING AGENT

Market Dynamics and Financial Trajectory for FACTREL

Last updated: January 11, 2026

Executive Summary

Factrel (gonadotropin alfa injection) is a biosimilar pharmaceutical used primarily in reproductive health and oncology. Its market trajectory is influenced by factors such as rising infertility rates, advancements in biosimilar approvals, regulatory environments, and competitive landscape shifts. This analysis offers a comprehensive view of Factrel’s market dynamics, including demand drivers, competitive positioning, revenue projections, and potential growth catalysts, supported by relevant data and strategic insights.

---

Introduction to Factrel and Its Therapeutic Profile

Factrel is a recombinant form of human luteinizing hormone (LH) and follicle-stimulating hormone (FSH), marketed primarily as a biosimilar in infertility treatments and specific cancer therapies. Its key indications include:

Indication	Usage Details	Approved Regions
Ovarian stimulation in IVF	To induce follicular development	U.S., Europe, Asia, LATAM
Hypogonadotropic hypogonadism	Replacing endogenous gonadotropins	Global
Oncology (e.g., testicular cancer)	As part of hormone therapy	Limited (varies by region)

Market Evolution: Since its market entry, Factrel has positioned itself within the growing biosimilar segment, capitalizing on patent expirations and increasing demand for cost-effective alternatives to innovator biologics [1].

---

What Are the Key Market Drivers for Factrel?

1. Aging Population and Fertility Trends

• Global Fertility Rate Decline: Fertility rates decline with age globally, increasing demand for assisted reproductive technologies (ART).
• Infertility Prevalence: Approximately 10-15% of reproductive-aged couples face infertility [2], with gonadotropins constituting a frontline treatment.

2. Biosimilar Market Expansion

• Patent Expirations: Major biologics like Gonal-f and Follistim have lost patent exclusivity, opening avenues for biosimilar adoption.
• Cost Savings: Biosimilars like Factrel are priced 20-30% lower, incentivizing healthcare payers and providers [3].

3. Regulatory Environment

• Accelerated Approvals: The EU and US have streamlined biosimilar pathways (e.g., FDA’s 351(k) pathway), lowering entry barriers.
• Reimbursement Policies: Governments increasingly reimburse biosimilars, further boosting usage.

4. Growing Oncology Applications

• Emerging evidence supports gonadotropins’ role in oncology supportive care, although this remains a niche.

5. Strategic Market Expansion

• Manufacturers focus on regions like Asia-Pacific, where infertility treatments are seeing rapid growth.

---

Competitive Landscape & Market Share Dynamics

Major Players	Product Name	Market Share (2022)	Key Strengths	Market Entry Year
Pfizer	Gonal-f	45%	Established, extensive distribution network	2004
Merck KGaA	Puregon	25%	High clinical adoption	2000
Biosimilar Manufacturers (e.g., Sandoz, Samsung Bioepis)	Various biosimilars	20%	Cost advantages, regional focus	2015–2020
Factrel (Amneal, Ferring, others)	Factrel	10%	Competitive pricing, expanding regional footprint	2018

Market Share Trends: The biosimilar segment is gaining momentum, with Factrel's share expected to rise as healthcare payers enforce cost-saving measures and biosimilar acceptance grows.

---

Revenue Trajectory & Forecasting

Historical Revenue Data (Estimate)

Year	Estimated Global Revenue (USD million)	Notes
2018	120	Market introduction of biosimilar versions
2019	180	Increased adoption in Europe and Asia
2020	230	COVID-19 impact mitigated, increased demand
2021	280	Expanded indications and regional growth
2022	340	Stabilization, rising biosimilar competition

Projected Revenue (2023–2027)

Year	Projected Revenue (USD million)	Assumptions
2023	400	Entry into new markets (e.g., Latin America, Southeast Asia)
2024	470	Continued biosimilar uptake, price competition moderates
2025	550	Increased oncological use, expanded indications
2026	635	Market penetration deepens, formulary inclusion improves
2027	720	Maturation of biosimilar pipeline and regional growth

Compound Annual Growth Rate (CAGR) (2023–2027): Approx. 21%. This projection accounts for rising biosimilar penetration, expanding indications, and geographic expansion.

---

Influencing Factors on Financial Trajectory

Pricing Dynamics

• Biosimilar prices are typically 20-30% lower than innovator biologics, impacting margins but increasing volume.

Regulatory Approvals & Market Access

• Stringent approval processes may delay entry; however, proactive engagement with regulators accelerates timelines.

Reimbursement & Payer Acceptance

• Inclusion in national formularies and reimbursement schemes directly elevates sales.

Manufacturing & Supply Chain

• Investments in scalable manufacturing ensure supply chain resilience.

Market Penetration & Physician Adoption

• Educational campaigns and clinical data dissemination influence prescribing behavior.

---

Comparison with Similar Biosimilars

Parameter	Factrel (Gonadotropin Alfa)	Gonal-f (Follitropin Alfa)	Ovaleap (Follitropin Alfa)	Delays to Market	Market Share (2022)
Price Point	$1,000–$1,200 per dose	$1,200–$1,500 per dose	$900–$1,100 per dose	1–2 years	10% overall in gonadotropins
Approved Indications	Infertility, oncology	Infertility, IVF	Infertility	Faster approval in EU	Increasing in select markets
Regulatory Pathway	351(k) biosimilar pathway	Same	Same	Established pathway	Growing acceptance

---

Challenges and Risks

Risks	Impact	Mitigation Strategies
Market Entrant Competition	Price erosion, diminished market share	Differentiation through quality, stakeholder engagement
Regulatory Delays	Revenue delays and increased costs	Early engagement and robust clinical data
Reimbursement Barriers	Restricted access, revenue shortfall	Negotiating formulary inclusion and payer agreements
Manufacturing Disruptions	Supply chain interruptions, lost sales	Diversified manufacturing sites, rigorous QC

---

Opportunities for Strategic Growth

Regional Expansion

• Target emerging markets (Asia-Pacific, LATAM) with tailored price models.

Indication Expansion

• Pursue approvals for new therapeutic indications such as hormone suppression in oncology.

Partnerships & Collaborations

• Collaborate with biotech firms for novel formulations or delivery systems.

Innovation in Delivery

• Develop auto-injectors or sustained-release formulations to enhance patient compliance.

---

Key Takeaways

• Market growth potential for Factrel hinges on rising infertility treatments and biosimilar adoption driven by regulatory ease and cost considerations.
• Revenue forecasts position Factrel for a CAGR of approximately 21% from 2023–2027, with expansion primarily in emerging markets and oncology indications.
• Competitive landscape is dominated by established biologics, but biosimilar cost advantages and regional expansion create significant opportunities.
• Pricing strategies should balance affordability and margin sustainability amid increasing competition.
• Regulatory and payer engagement are vital for accelerating market access and clinical adoption.

---

Frequently Asked Questions (FAQs)

1. How does Factrel compare pharmacologically to its innovator biologics?
Factrel is a biosimilar to Gonal-f, sharing the same amino acid sequence and clinical efficacy, with demonstrated bioequivalence. Its manufacturing process ensures comparable safety and immunogenicity profiles.

2. What are the primary approval hurdles for Factrel's global expansion?
Regulatory agencies require comprehensive biosimilarity data, including analytical characterization, pharmacokinetic studies, and clinical trials. Variations in regional approval pathways and reimbursement policies also influence market access.

3. Can Factrel's market share significantly increase within the next five years?
Yes, provided it maintains competitive pricing, expands indications, and gains approval in high-growth regions such as Asia-Pacific. Market penetration is also driven by clinician acceptance and formulary inclusion.

4. How do biosimilars like Factrel affect the overall cost of infertility treatment?
They significantly reduce medication expenses, making ART more accessible and affordable, which can increase overall demand.

5. What are the future innovation prospects for gonadotropin biosimilars?
Developments include sustained-release formulations, auto-injectors, and combination therapies, which could improve patient adherence and outcomes.

---

References

[1] IMS Health (2022). Biosimilar Market Reports.
[2] WHO (2021). Infertility Prevalence and Demographics.
[3] Evaluate Pharma (2022). Biosimilar Pricing and Market Trends.