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

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

International Patents for FACTREL

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

Country	Patent Number	Title	Estimated Expiration
South Africa	7801361
Switzerland	589608
Australia	476785
Israel	41313

FACTREL (gonadorelin hydrochloride) - Investment and Fundamentals Analysis

Last updated: February 10, 2026

Summary:
FACTREL, marketed by Ferring Pharmaceuticals, is a gonadotropin-releasing hormone (GnRH) analog used primarily in fertility treatment and androgen deprivation therapy. Its market position is supported by its generics presence and specific medical applications. Investment considerations hinge on patent status, market penetration, regulatory landscape, and pipeline development.

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What Is the Market Position of FACTREL?

FACTREL's primary use is in adult male and female fertility treatments, including diagnosis of hypogonadism and controlled ovarian stimulation, and in prostate cancer therapy. The drug is available in multiple markets globally, often as a generic, which limits pricing power but ensures widespread accessibility.

Market size estimates for GnRH analogs used in fertility are valued at approximately $2.5 billion globally in 2022, with growth driven by increasing infertility rates and aging populations. The segment is fragmented, dominated by a few key players such as Ferring, Ipsen, and TEVA, and characterized by low to moderate pricing pressures due to generic competition.

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What Are the Key Patent and Regulatory Factors?

FACTREL is a generic formulation, with original patents expiring around 2001-2003 in principal markets. As a result, patent exclusivity does not limit its competition. The drug's regulatory status varies:

• United States: Approved via FDA’s Abbreviated New Drug Application (ANDA) pathway as a generic. No current patent protections are active.
• Europe: Approved through the European Medicines Agency (EMA), with patent expiry prior to 2004.
• Other Markets: Similar timelines for patent expirations; generic entry has been present for decades.

Lack of patent protection means the upside is limited to volume growth, market share, and potential new formulations or delivery devices.

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What Are the Underlying Revenue and Cost Dynamics?

• Pricing: The global price per dose ranges from $10 to $50, depending on the country, insurance coverage, and manufacturer.
• Market Penetration: Due to its generic status, margins are thin. Primary revenue drivers include volume sales and regional expansion.
• Manufacturing Cost: Low, due to high biopharmaceutical production efficiency; gross margins historically exceed 60% for manufacturers of generic GnRH drugs.

Actual sales data are scarce publicly; however, estimates indicate that top producers sell hundreds of millions annually across all forms of GnRH used for fertility or prostate cancer.

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What Are Future Market Drivers and Challenges?

Drivers:

• Rising infertility rates in developed countries.
• Aging male populations requiring androgen deprivation therapy.
• Increased adoption of fertility treatments owing to societal shifts toward delayed childbearing.
• Regulatory approval of new delivery formats, such as nasal sprays or auto-injectors, could enhance compliance and sales.

Challenges:

• Entry of biosimilars and generics abroad could pressure prices.
• Healthcare cost containment measures could limit reimbursement.
• Competitive disadvantage due to lack of patent protection, disadvantaging R&D-driven differentiation.

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What Are Investment Risks and Opportunities?

Risks:

• Price erosion caused by biosimilars and generic competition.
• Regulatory changes or reimbursement policy shifts.
• Limited pipeline; the drug’s fundamental patent expiring decades ago.

Opportunities:

• Market expansion into emerging markets where fertility treatment is gaining acceptance.
• New formulations or delivery systems that improve patient adherence might revive sales.
• Strategic partnerships or licensing agreements for regional market expansion.

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Key Takeaways:

• FACTREL is a mature, off-patent generic drug with established worldwide markets.
• Revenue growth relies on volume increases rather than price escalation.
• Market expansion in fertility and prostate cancer segments remains possible.
• Competitive pressures from biosimilars and generics challenge margins.
• Innovation focus is necessary to sustain long-term value in a commoditized environment.

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FAQs

1. What is the primary revenue driver for FACTREL?
   Volume sales in established markets due to its status as a generic.

2. Are there patent protections for FACTREL?
   No; patent protections expired 2001-2003 in key markets.

3. What markets offer the best growth potential for FACTREL?
   Emerging markets with increasing fertility treatments and aging populations.

4. How does biosimilar competition impact FACTREL?
   Biosimilars and generics can lead to significant price reductions, pressuring margins.

5. Is there any pipeline innovation for FACTREL?
   Currently limited; potential exists in delivery methods to improve compliance and patient experience.

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References

[1] Market reports on GnRH analogs.
[2] Ferring Pharmaceuticals product and patent information.
[3] FDA and EMA regulatory approval databases.