GONAL-F RFF REDIJECT Drug Profile

Summary for Tradename: GONAL-F RFF REDIJECT

High Confidence Patents:	9
Applicants:	1
BLAs:	1

Pharmacology for GONAL-F RFF REDIJECT

Established Pharmacologic Class	Gonadotropin
Chemical Structure	Gonadotropins

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. DrugPatentWatch analysis and company disclosures

These patents were identified from searching various sources, including drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for GONAL-F RFF REDIJECT Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for GONAL-F RFF REDIJECT Derived from DrugPatentWatch Analysis and Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Emd Serono, Inc.	GONAL-F RFF REDIJECT	follitropin alfa	Injection	021684		2036-12-20	DrugPatentWatch analysis and company disclosures
Emd Serono, Inc.	GONAL-F RFF REDIJECT	follitropin alfa	Injection	021684		2034-02-06	DrugPatentWatch analysis and company disclosures
Emd Serono, Inc.	GONAL-F RFF REDIJECT	follitropin alfa	Injection	021684		2038-12-19	DrugPatentWatch analysis and company disclosures
Emd Serono, Inc.	GONAL-F RFF REDIJECT	follitropin alfa	Injection	021684		2009-10-20	DrugPatentWatch analysis and company disclosures
Emd Serono, Inc.	GONAL-F RFF REDIJECT	follitropin alfa	Injection	021684		2015-06-16	DrugPatentWatch analysis and company disclosures
Emd Serono, Inc.	GONAL-F RFF REDIJECT	follitropin alfa	Injection	021684		2013-01-22	DrugPatentWatch analysis and company disclosures
Emd Serono, Inc.	GONAL-F RFF REDIJECT	follitropin alfa	Injection	021684		2026-07-07	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for GONAL-F RFF REDIJECT Derived from Patent Text Search

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Emd Serono, Inc.	GONAL-F RFF REDIJECT	follitropin alfa	Injection	021684		2036-12-20	Patent claims search
Emd Serono, Inc.	GONAL-F RFF REDIJECT	follitropin alfa	Injection	021684		2034-02-06	Patent claims search
Emd Serono, Inc.	GONAL-F RFF REDIJECT	follitropin alfa	Injection	021684		2038-12-19	Patent claims search
Emd Serono, Inc.	GONAL-F RFF REDIJECT	follitropin alfa	Injection	021684		2038-07-09	Patent claims search
Emd Serono, Inc.	GONAL-F RFF REDIJECT	follitropin alfa	Injection	021684		2038-09-17	Patent claims search
Emd Serono, Inc.	GONAL-F RFF REDIJECT	follitropin alfa	Injection	021684		2041-01-15	Patent claims search
Emd Serono, Inc.	GONAL-F RFF REDIJECT	follitropin alfa	Injection	021684		2029-12-18	Patent claims search

International Patents for GONAL-F RFF REDIJECT

Country	Patent Number	Estimated Expiration
China	103930595
South Korea	910002692
South Korea	20180100710
Canada	2761905
Japan	H07203968
European Patent Office	2251453
Denmark	0974359

Supplementary Protection Certificates for GONAL-F RFF REDIJECT

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
SZ 13/2001	Austria		PRODUCT NAME: LUTROPIN ALFA
SZ 17/2001	Austria		PRODUCT NAME: CHORIOGONADOTROPHIN ALFA
SZ 6/2010	Austria		PRODUCT NAME: CORIFOLLITROPIN ALFA
CA 2010 00005	Denmark		PRODUCT NAME: CORIFOLLITROPIN ALFA
SZ 5/1996	Austria		PRODUCT NAME: REKOMBINANTES HUMANES FOLLIKELSTIMULIERENDES HORMON
SPC/GB10/022	United Kingdom		PRODUCT NAME: CORIFOLLITROPIN ALFA; REGISTERED: UK EU/1/09/609/001 20100125; UK EU/1/09/609/002 20100125
6/2010	Austria		PRODUCT NAME: CORIFOLLITROPIN ALFA; REGISTRATION NO/DATE: EU/1/09/609/001-002 20100125

Market Dynamics and Financial Trajectory for GONAL-F RFF REDIJECT

Last updated: February 20, 2026

What is the current market positioning of GONAL-F RFF REDIJECT?

GONAL-F RFF REDIJECT is a recombinant human follicle-stimulating hormone (rFSH) used primarily for ovarian stimulation in women undergoing assisted reproductive technologies (ART). It is produced by Merck KGaA, marketed globally, with specific presence in North America, Europe, and Asia-Pacific regions.

It competes mainly with biosimilar versions of GONAL-F and other branded recombinant FSH products like Follistim and Gonal-f alike in the fertility treatments market segment.

What are the core market drivers influencing GONAL-F RFF REDIJECT's demand?

• Increasing IVF procedures: Global IVF markets expand at an estimated CAGR of 7.5% from 2022-2027 (Grand View Research, 2022). Rising infertility rates, delayed childbearing, and technological advancements propel this growth.
• Rising fertility treatment acceptance: Spurred by social acceptance and affordability increases in some regions.
• Product innovation: The introduction of rediJect technology reduces needle handling and improves convenience, potentially broadening user adoption.
• Market penetration through biosimilars: The expiration of patents for some branded FSH products prompts biosimilar entry, intensifying competitive pressure.

What are the revenue projections and financial trends?

Revenue Overview (2022–2027)

Year	Estimated Global Market Size (USD billion)	GONAL-F RFF REDIJECT Estimated Share	Revenue (USD million)
2022	2.8	15%	420
2023	3.0	16%	480
2024	3.3	17%	561
2025	3.6	18.5%	666
2026	4.0	20%	800

Assumption: GONAL-F RFF REDIJECT maintains a gradual market share increase due to technological adoption and biosimilar competition.

Financial margins and pricing

• Unit price: GONAL-F RFF REDIJECT retails at approximately USD 1,200-1,400 per for a 75 IU dose, depending on the market.
• Margins: Estimated gross margins are around 50%, given production costs and competitive pressures.

Impact of biosimilar competition

Biosimilars launched since 2018 reduce GONAL-F's price by approximately 20-30%. Market share for branded GONAL-F products could decline from 25% to 15% over five years due to biosimilar penetration.

How do regulatory and market access factors influence financial prospects?

• Regulatory approvals: GONAL-F RFF REDIJECT holds approval in over 90 countries. Future approvals could extend reach.
• Market access: Reimbursement and coverage remain critical. Favorable coverage increases demand; limitations suppress growth.
• Pricing policies: Governments in Europe tend to limit drug prices, impacting revenue growth. In contrast, North American markets have more flexibility.

What are the outlook risks and opportunities?

Risks

• Patent challenges and biosimilar entry: Biosimilar competition threatens revenue streams.
• Pricing pressure: National healthcare authorities regulate prices, especially in Europe.
• Market saturation: With high adoption in mature markets, growth slows.

Opportunities

• New indications: Expanded uses in other reproductive disorders could enhance sales.
• Technological differentiation: Continued innovation in formulation and delivery.
• Emerging markets: Asia-Pacific and Latin America offer considerable growth potential due to rising fertility treatment rates.

Key Takeaways

• GONAL-F RFF REDIJECT operates in a high-growth segment driven by infertility and IVF procedure expansion.
• Revenue is projected to increase from USD 420 million in 2022 to approximately USD 800 million by 2026, assuming steady market penetration.
• Biosimilar competition and regulation are major factors influencing profitability.
• The market's future hinges on technological advantages, regulatory approvals, and market access strategies.

FAQs

Q1: How does GONAL-F RFF REDIJECT differ from traditional GONAL-F?
A1: It uses a rediJect delivery system, reducing the need for needle handling, improving patient convenience.

Q2: What is the competitive landscape for FSH products?
A2: It includes biosimilars from various manufacturers, branded products like Follistim and Gonal-f, with biosimilars increasing price competition.

Q3: Which regions offer the highest growth potential?
A3: Asia-Pacific and Latin America exhibit high growth due to demographic trends and increasing healthcare infrastructure.

Q4: How do regulatory policies impact sales?
A4: Stringent pricing controls in Europe restrict revenue growth, while more flexible policies in North America support higher margins.

Q5: What future innovations could sustain GONAL-F RFF REDIJECT's market position?
A5: Next-generation formulations, personalized dosing algorithms, and expanded indications could bolster demand.

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References

[1] Grand View Research. (2022). Fertility Drugs Market Size, Share & Trends Analysis.
[2] European Medicines Agency. (2022). GONAL-F Summary of Product Characteristics.
[3] IQVIA. (2022). Fertility Treatment Market Data.