Follitropin beta - Biologic Drug Details

Summary for follitropin beta

Tradenames:	3
High Confidence Patents:	4
Applicants:	2
BLAs:	3
Suppliers: see list	2

Pharmacology for follitropin beta

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. General brand-side disclosures

These patents were identified from searching 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 follitropin beta Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for follitropin beta Derived from Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Organon Usa Llc, A Subsidiary Of Organon & Co.	FOLLISTIM AQ CARTRIDGE	follitropin beta	Injection	021211	5,767,251	2015-06-16	Company disclosures
Organon Usa Llc, A Subsidiary Of Organon & Co.	FOLLISTIM AQ CARTRIDGE	follitropin beta	Injection	021211	5,929,028	2017-01-15	Company disclosures
Organon Usa Llc, A Subsidiary Of Organon & Co.	FOLLISTIM AQ CARTRIDGE	follitropin beta	Injection	021211	7,446,090	2018-07-23	Company disclosures
Organon Usa Llc, A Subsidiary Of Organon & Co.	FOLLISTIM AQ CARTRIDGE	follitropin beta	Injection	021211	7,563,763	2018-07-23	Company disclosures
Organon Usa Inc., A Subsidiary Of Merck & Co., Inc.	FOLLISTIM AQ	follitropin beta	Injection	021273	5,929,028	2017-01-15	Company disclosures

3) Low Certainty: US Patents for follitropin beta 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
Organon Usa Inc., A Subsidiary Of Merck & Co., Inc.	FOLLISTIM	follitropin beta	For Injection	020582	10,016,338	2033-03-11	Patent claims search
Organon Usa Inc., A Subsidiary Of Merck & Co., Inc.	FOLLISTIM	follitropin beta	For Injection	020582	10,182,561	2024-12-29	Patent claims search
Organon Usa Inc., A Subsidiary Of Merck & Co., Inc.	FOLLISTIM	follitropin beta	For Injection	020582	10,577,154	2029-05-13	Patent claims search
Organon Usa Inc., A Subsidiary Of Merck & Co., Inc.	FOLLISTIM	follitropin beta	For Injection	020582	10,656,152	2029-01-29	Patent claims search
Organon Usa Inc., A Subsidiary Of Merck & Co., Inc.	FOLLISTIM	follitropin beta	For Injection	020582	10,786,662	2037-01-05	Patent claims search

International Patents for follitropin beta

Country	Patent Number	Estimated Expiration
European Patent Office	0211894
Hong Kong	143295
Spain	2183486
European Patent Office	0160699
European Patent Office	0160091

Supplementary Protection Certificates for follitropin beta

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2010C/023	Belgium		PRODUCT NAME: CORIFOLLITROPIN ALFA; AUTHORISATION NUMBER AND DATE: EU/1/09/609/001 20100126
122010000011	Germany		PRODUCT NAME: CORIFOLLITROPIN ALFA; REGISTRATION NO/DATE: EU/1/09/609/001-002 20100125
6/2010	Austria		PRODUCT NAME: CORIFOLLITROPIN ALFA; REGISTRATION NO/DATE: EU/1/09/609/001-002 20100125
CA 2010 00022	Denmark		PRODUCT NAME: REKOMBINANT FSH-CTP
SPC/GB96/011	United Kingdom		PRODUCT NAME: RECOMBINANT HUMAN FOLLICLE STIMULATING HORMONE; REGISTERED: FI 11529 19940815; FI 11530 19940815; UK EU/1/95/001 19951020; UK EU/1/95/002 19951020; UK EU/1/95/003 19951020; UK EU/1/95/004 19951020; UK EU/1/95/005 19951020; UK EU/1/95/006 19951020; UK EU/1/95/007 19951020; UK EU/1/95/008 19951020; UK EU/1/95/009 19951020; UK EU/1/95/010 19951020; UK EU/1/95/011 19951020; UK EU/1/95/012 19951020; UK EU/1/95/013 19951020; UK EU/1/95/014 19951020; UK EU/1/95/015 19951020; UK EU/1/95/016 19951020

Follitropin beta Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Follitropin Beta

Overview of Follitropin Beta

Follitropin beta, known by the brand name Follistim, is a recombinant follicle-stimulating hormone (FSH) used primarily in the treatment of female infertility, particularly in assisted reproductive technologies (ART) such as in vitro fertilization (IVF)[2].

Market Growth and Projections

Global Infertility Drug Market

The global female infertility drug market, which includes follitropin beta, is projected to grow at a significant rate. This market is expected to increase at a Compound Annual Growth Rate (CAGR) of 3.4% from 2018 to 2028, reaching a market value of $2.5 billion by the end of the forecast period, up from $1.8 billion in 2018[2].

Specific Growth of Follitropin Beta

Follistim, the brand name for follitropin beta, has seen remarkable growth. In the fourth quarter of 2023, Follistim experienced a 63% growth on an ex-foreign exchange (ex-FX) basis, driven by a one-time buy-in related to the exit of the Interim Operating Model (IOM)[2].

Market Segmentation

Type of Follitropin

The market for follitropin is segmented based on type, with follitropin beta being a key segment. In 2023, the urine-derived follicle stimulating hormone segment accounted for a noticeable share of the global follitropin market, but follitropin beta is expected to experience significant growth in the near future[1].

Application

The infertility treatment segment, where follitropin beta is predominantly used, is expected to expand at a significant CAGR throughout the forecast period. This segment is driven by the increasing demand for ART treatments and the launch of new fertility treatments[1][2].

Financial Performance

Revenue Growth

The strong growth of Follistim has significantly contributed to the revenue of its manufacturer. In the fourth quarter of 2023, the total revenue for the company increased by 8% on an as-reported basis and 8% ex-FX, with Women’s Health revenue, which includes fertility products, growing by 7% as-reported and 8% ex-FX[2].

Profitability

The financial performance of Follistim is reflected in the overall profitability of its manufacturer. For the fourth quarter of 2023, the company reported a net income of $546 million, or $2.13 per diluted share, with an adjusted EBITDA margin of 28.1%[2].

Regional Performance

North America

North America is a significant market for Follistim, driven by the high demand for fertility treatments in the region. The launch and rapid increase of various fertility medicines in this region are expected to continue driving growth[2].

Global Expansion

While North America is a key market, Follistim also sees growth in other regions. The drug's performance is bolstered by launches and increased demand in various international markets, contributing to its global financial trajectory[2].

Distribution and Sales Channels

Hospital Pharmacies

Hospital pharmacies hold a significant market share for infertility drugs, including Follistim. This segment is expected to grow at an 8.9% CAGR, indicating strong demand through this distribution channel[2].

Online and Retail Pharmacies

In addition to hospital pharmacies, online and retail pharmacies are also growing segments. These channels provide convenient access to fertility medications, further driving the sales of Follistim[2].

Challenges and Opportunities

Generic Competition

While Follistim has seen strong growth, the market is not without challenges. Generic competition, particularly for other fertility and women’s health products, can impact the overall market dynamics. However, Follistim's brand strength and clinical efficacy have helped it maintain its market position[2].

Research and Development

Continuous research and development in the field of infertility treatments present opportunities for growth. Collaborations such as the one between Ferring B.V. and Igenomix for developing novel healing products can lead to new market opportunities and further solidify Follistim's position[2].

Technological Advancements

Glycosylation and Pharmacokinetics

Recent studies have highlighted the importance of glycosylation in follitropin preparations. Follitropin beta has been shown to induce a greater estradiol response in patients compared to follitropin alpha, which is associated with a higher pregnancy rate. Genetic engineering to increase glycosylation and prolong the half-life of follitropin has led to new forms of the drug, such as long-acting follitropin preparations available in Europe[4].

Biosimilars

The introduction of biosimilar follitropin preparations, such as Bemfola, presents both challenges and opportunities. While biosimilars can increase competition, they also expand access to affordable biopharmaceuticals, maintaining an environment that supports innovation and competition in the biotechnology market[4].

Market Drivers

Increasing Demand for ART

The increasing demand for assisted reproductive technologies (ART) is a key driver for the growth of Follistim. As more individuals seek fertility treatments, the demand for effective and reliable drugs like follitropin beta continues to rise[2].

Launch of New Treatments

The launch of new fertility treatments and the expansion of existing product lines also drive market growth. These new treatments often offer improved efficacy and convenience, attracting more patients and healthcare providers to the market[2].

Key Companies

Market Dominance

Companies such as Merck (manufacturer of Follistim), Ferring Pharmaceuticals, and EMD Serono dominate the female infertility drug market. These companies are focusing on strategy building models to strengthen their product portfolios and expand their business in the global market[1][2].

Regulatory Environment

Abbreviated Approval Pathway

The Patient Protection and Affordable Care Act (PPAC Act) has created an abbreviated approval pathway for biological products that are demonstrated to be “highly similar” or “interchangeable” with an FDA-approved biological product. This pathway can impact the market dynamics by allowing for the introduction of biosimilars, which can increase competition and reduce costs[4].

Consumer Behavior

Increasing Awareness

Consumer awareness about fertility treatments and the availability of effective drugs like Follistim is increasing. This awareness, coupled with the growing desire for family planning and reproductive health, drives the demand for these medications[1].

Market Attractiveness

Regional Analysis

The global follitropin market is segmented into five major regions: North America, Europe, Asia Pacific, Middle East & Africa, and Latin America. Each region provides unique opportunities and challenges, with North America being a particularly significant market due to high demand for fertility treatments[1].

SWOT Analysis

Strengths

• Strong brand presence and clinical efficacy of Follistim.
• Continuous research and development in infertility treatments.
• Significant market share in North America and other regions.

Weaknesses

• Potential generic competition from biosimilars.
• Dependence on a few key markets for revenue.

Opportunities

• Growing demand for ART and fertility treatments.
• Expansion into new international markets.
• Technological advancements in glycosylation and pharmacokinetics.

Threats

• Regulatory changes affecting the approval pathway for biologics.
• Increasing competition from new market entrants.

Key Takeaways

• Market Growth: The global female infertility drug market is expected to grow at a CAGR of 3.4% from 2018 to 2028.
• Strong Performance: Follistim saw a 63% growth in the fourth quarter of 2023 on an ex-FX basis.
• Market Drivers: Increasing demand for ART and the launch of new treatments are key drivers.
• Market Share: Follistim, along with other dominant players, accounts for over 50% of the market share.
• Financial Performance: Strong revenue and profitability are reflected in the company's financial reports.
• Regional Performance: North America is a significant market, with growth also seen in international markets.
• Distribution Channels: Hospital pharmacies and online/retail pharmacies are key distribution channels.

FAQs

Q: What is the projected CAGR for the global female infertility drug market?

A: The global female infertility drug market is projected to grow at a CAGR of 3.4% from 2018 to 2028[2].

Q: How did Follistim perform in the fourth quarter of 2023?

A: Follistim grew 63% on an ex-FX basis in the fourth quarter of 2023 due to a one-time buy-in related to the exit of the Interim Operating Model (IOM)[2].

Q: What are the main drivers for the growth of Follistim?

A: The main drivers include the increasing demand for ART treatments and the launch of new fertility treatments[2].

Q: Which companies dominate the female infertility drug market?

A: EMD Serono’s Gonal-F, Merck’s Follistim, and Ferring Pharmaceuticals’ Menopur dominate the market[2].

Q: How does glycosylation impact the pharmacokinetics of follitropin beta?

A: Glycosylation differences between follitropin alpha and beta can affect their relative pharmacokinetics and bioactivities, with follitropin beta inducing a greater estradiol response in patients[4].

Sources

1. Global Follitropin Market Report 2024 Edition - Cognitivemarketresearch.com
2. Follistim - Drugpatentwatch.com
3. Follow-On Biologic Competition in the Biopharmaceutical Industry - DTIC
4. New Human Follitropin Preparations: How Glycan Structural Variations Affect Their Action - Frontiersin.org
5. Historical perspectives in gonadotrophin therapy - Oxford Academic