FOLLISTIM Drug Profile

✉ Email this page to a colleague

Summary for Tradename: FOLLISTIM

High Confidence Patents:	4
Applicants:	2
BLAs:	3
Drug Prices:	Drug price information for FOLLISTIM
Recent Clinical Trials:	See clinical trials for FOLLISTIM

See drug prices for FOLLISTIM

Recent Clinical Trials for FOLLISTIM

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Ferring Pharmaceuticals	Phase 2
Center for Human Reproduction	Phase 1/Phase 2
Michigan Reproductive Medicine	Phase 4

See all FOLLISTIM clinical trials

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:

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.

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.

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 FOLLISTIM Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

These patents were obtained from company disclosures

Glossary

Subscribe to access the full database, or Subscribe
Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Organon Usa Inc., A Subsidiary Of Merck & Co., Inc.	FOLLISTIM AQ	follitropin beta	Injection	021273	⤷ Subscribe	2017-01-15	Company disclosures
Organon Usa Llc, A Subsidiary Of Organon & Co.	FOLLISTIM AQ CARTRIDGE	follitropin beta	Injection	021211	⤷ Subscribe	2015-06-16	Company disclosures
Organon Usa Llc, A Subsidiary Of Organon & Co.	FOLLISTIM AQ CARTRIDGE	follitropin beta	Injection	021211	⤷ Subscribe	2017-01-15	Company disclosures
Organon Usa Llc, A Subsidiary Of Organon & Co.	FOLLISTIM AQ CARTRIDGE	follitropin beta	Injection	021211	⤷ Subscribe	2018-07-23	Company disclosures
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Patent No.	>Estimated Patent Expiration	>Source

3) Low Certainty: US Patents for FOLLISTIM Derived from Patent Text Search

These patents were obtained by searching patent claims

Glossary

Subscribe to access the full database, or Subscribe
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	⤷ Subscribe	2033-03-11	Patent claims search
Organon Usa Inc., A Subsidiary Of Merck & Co., Inc.	FOLLISTIM	follitropin beta	For Injection	020582	⤷ Subscribe	2024-12-29	Patent claims search
Organon Usa Inc., A Subsidiary Of Merck & Co., Inc.	FOLLISTIM	follitropin beta	For Injection	020582	⤷ Subscribe	2029-05-13	Patent claims search
Organon Usa Inc., A Subsidiary Of Merck & Co., Inc.	FOLLISTIM	follitropin beta	For Injection	020582	⤷ Subscribe	2029-01-29	Patent claims search
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Patent No.	>Estimated Patent Expiration	>Source

International Patents for FOLLISTIM

Subscribe to access the full database, or Subscribe
Country	Patent Number	Estimated Expiration
European Patent Office	0211894	⤷ Subscribe
Hong Kong	143295	⤷ Subscribe
Spain	2183486	⤷ Subscribe
European Patent Office	0160699	⤷ Subscribe
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for FOLLISTIM

Subscribe to access the full database, or Subscribe
Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2010C/023	Belgium	⤷ Subscribe	PRODUCT NAME: CORIFOLLITROPIN ALFA; AUTHORISATION NUMBER AND DATE: EU/1/09/609/001 20100126
122010000011	Germany	⤷ Subscribe	PRODUCT NAME: CORIFOLLITROPIN ALFA; REGISTRATION NO/DATE: EU/1/09/609/001-002 20100125
6/2010	Austria	⤷ Subscribe	PRODUCT NAME: CORIFOLLITROPIN ALFA; REGISTRATION NO/DATE: EU/1/09/609/001-002 20100125
CA 2010 00022	Denmark	⤷ Subscribe	PRODUCT NAME: REKOMBINANT FSH-CTP
>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

FOLLISTIM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Follistim (Follitropin Beta)

Overview of Follistim

Follistim, a recombinant follicle-stimulating hormone (FSH) known as follitropin beta, is a crucial drug in the treatment of female infertility. It is manufactured by Merck and is used in assisted reproductive technologies (ART) such as in vitro fertilization (IVF).

Market Growth and Projections

Global Infertility Drug Market

The global female infertility drug market, which includes Follistim, is expected to grow at a significant rate. According to recent research, this market is projected 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[1].

Specific Growth of Follistim

Follistim has been a key player in this market. In the fourth quarter of 2023, Follistim saw a remarkable growth of 63% 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 Drivers

Increasing Demand for ART

The growing number of women postponing pregnancy until later in life, when fertility naturally declines, is a significant driver for the increased use of ART treatments. This trend is expected to continue, driving the demand for fertility drugs like Follistim[1].

Launch of New Treatments

Although the pipeline for female infertility treatments is sparse, the launch of new drugs such as ObsEva’s nolasiban in the EU and US is expected to further boost the market. However, Follistim remains a dominant player due to its established presence and efficacy[1].

Market Share and Competition

Dominant Market Players

In 2018, Follistim, along with EMD Serono’s Gonal-F (follitropin alfa) and Ferring Pharmaceuticals’ Menopur (menotropins), accounted for over 50% of the market share in the female infertility drug market. This dominance underscores the strong market position of Follistim[1].

Competitive Landscape

The market is competitive, with several other fertility drugs available. However, Follistim's strong performance and the lack of significant new entrants in the market have helped it maintain its market share.

Financial Performance

Revenue Growth

In the fourth quarter of 2023, the strong growth of Follistim contributed significantly to the revenue of its manufacturer. 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[4].

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[3].

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[4].

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[4].

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[3].

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[4].

Key Takeaways

Market Growth: The global female infertility drug market, including Follistim, 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[1].

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[1].

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[1].

Q: What is the significance of North America in the market for Follistim?

A: North America is a significant market for Follistim, driven by high demand for fertility treatments and research activities in the region[4].

Sources

European Pharmaceutical Review: "Female infertility drug market to exhibit CAGR of 3.4 percent"[1].
Organon Q4 2023 Press Release: "OGN Q4 2023 Press Release"[2].
Biospace: "Organon Reports Results for the Third Quarter Ended September 30, 2024"[3].
Market.us: "Infertility Drugs Market Size, Outlook | CAGR 6.2%"[4].

More… ↓

⤷ Subscribe