FOLLISTIM AQ Drug Profile

Summary for Tradename: FOLLISTIM AQ

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

See drug prices for FOLLISTIM AQ

Recent Clinical Trials for FOLLISTIM AQ

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 AQ 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:

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 FOLLISTIM AQ Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for FOLLISTIM AQ 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 Inc., A Subsidiary Of Merck & Co., Inc.	FOLLISTIM AQ	follitropin beta	Injection	021273	5,929,028	2017-01-15	Company disclosures
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

3) Low Certainty: US Patents for FOLLISTIM AQ 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 AQ	follitropin beta	Injection	021273	10,016,338	2033-03-11	Patent claims search
Organon Usa Inc., A Subsidiary Of Merck & Co., Inc.	FOLLISTIM AQ	follitropin beta	Injection	021273	10,182,561	2024-12-29	Patent claims search
Organon Usa Inc., A Subsidiary Of Merck & Co., Inc.	FOLLISTIM AQ	follitropin beta	Injection	021273	10,577,154	2029-05-13	Patent claims search
Organon Usa Inc., A Subsidiary Of Merck & Co., Inc.	FOLLISTIM AQ	follitropin beta	Injection	021273	10,656,152	2029-01-29	Patent claims search
Organon Usa Inc., A Subsidiary Of Merck & Co., Inc.	FOLLISTIM AQ	follitropin beta	Injection	021273	10,786,662	2037-01-05	Patent claims search
Organon Usa Inc., A Subsidiary Of Merck & Co., Inc.	FOLLISTIM AQ	follitropin beta	Injection	021273	10,912,714	2038-07-09	Patent claims search
Organon Usa Inc., A Subsidiary Of Merck & Co., Inc.	FOLLISTIM AQ	follitropin beta	Injection	021273	11,298,293	2033-03-11	Patent claims search

International Patents for FOLLISTIM AQ

Country	Patent Number	Estimated Expiration
Denmark	297185
World Intellectual Property Organization (WIPO)	8501958
Japan	S61500251
Mexico	9203334
Argentina	011410
Peru	20000939
Japan	H07241194

Supplementary Protection Certificates for FOLLISTIM AQ

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2001C/020	Belgium		PRODUCT NAME: LUTROPINE ALFA; REGISTRATION NO/DATE: EU/1/00/155/001 20001129
2010C/023	Belgium		PRODUCT NAME: CORIFOLLITROPIN ALFA; AUTHORISATION NUMBER AND DATE: EU/1/09/609/001 20100126
SZ 6/2010	Austria		PRODUCT NAME: CORIFOLLITROPIN ALFA
SPC/GB01/030	United Kingdom		PRODUCT NAME: RECOMBINANT CHORIOGONADOTROPIN ALFA; REGISTERED: UK EU/1/00/165/001-006 20010202
SPC019/2010	Ireland		SPC019/2010: 20101001, EXPIRES: 20230112
122010000011	Germany		PRODUCT NAME: CORIFOLLITROPIN ALFA; REGISTRATION NO/DATE: EU/1/09/609/001-002 20100125
10C0024	France		PRODUCT NAME: CORIFOLLITROPINE ALPHA; REGISTRATION NO/DATE: EU/1/09/609/001 20100125

Market Dynamics and Financial Trajectory for the Biologic Drug: FOLLISTIM AQ

Introduction to FOLLISTIM AQ

FOLLISTIM AQ, a recombinant follicle-stimulating hormone (rFSH), is a biologic drug used primarily in fertility treatments. Developed by Organon (now part of Merck & Co.), it has been a significant player in the reproductive health market since its approval in the late 1990s.

Market Overview

The fertility treatment market has seen substantial growth over the past few decades, driven by increasing awareness, advances in medical technology, and changing societal norms. Here are some key aspects of the market:

Growing Demand for Fertility Treatments

• The global fertility treatment market is projected to grow significantly, driven by factors such as delayed childbearing, rising infertility rates, and an increase in same-sex couples seeking fertility services.
• According to a report by Grand View Research, the global fertility services market size was valued at USD 24.6 billion in 2020 and is expected to grow at a CAGR of 8.5% from 2021 to 2028[1].

Competitive Landscape

• The market for fertility treatments is highly competitive, with several biologic drugs and other treatments available.
• Key competitors include Gonal-F (Merck Serono), Puregon (Merck & Co.), and Bravelle (Ferring Pharmaceuticals).
• The competitive landscape is characterized by continuous innovation, with companies investing heavily in research and development to improve treatment outcomes and patient convenience.

Regulatory Environment

Approval and Licensing

• FOLLISTIM AQ was approved by the FDA in 1997 for use in ovulation induction and assisted reproductive technologies (ART) such as in vitro fertilization (IVF).
• Regulatory approvals are critical for biologic drugs, and any changes in regulatory policies can significantly impact the market trajectory.

Safety and Efficacy Standards

• Biologic drugs like FOLLISTIM AQ are subject to stringent safety and efficacy standards.
• Post-marketing surveillance and periodic reviews by regulatory bodies ensure that the drug continues to meet safety and efficacy criteria.

Financial Performance

Revenue Trends

• FOLLISTIM AQ has been a revenue generator for Merck & Co., although its sales have fluctuated over the years due to market competition and pricing pressures.
• In recent years, the drug has faced challenges from biosimilars and generic versions, which have impacted its revenue.

Pricing Strategies

• Pricing for biologic drugs is complex and influenced by factors such as market competition, regulatory environment, and healthcare policies.
• Companies often employ tiered pricing strategies to make the drug more accessible in different markets.

Market Segmentation

Patient Demographics

• The primary users of FOLLISTIM AQ are women undergoing fertility treatments, particularly those with polycystic ovary syndrome (PCOS) or other ovulatory disorders.
• There is also a growing segment of same-sex couples and single individuals seeking fertility services.

Geographic Markets

• The demand for FOLLISTIM AQ is global, with significant markets in North America, Europe, and Asia-Pacific.
• Emerging markets in Latin America and Africa are also showing potential for growth.

Technological Advancements

Innovations in Delivery Systems

• Advances in delivery systems, such as prefilled pens and auto-injectors, have improved patient convenience and adherence to treatment.
• For example, the FOLLISTIM AQ Cartridge system allows for easier administration and reduced risk of dosing errors.

Personalized Medicine

• There is a growing trend towards personalized medicine in fertility treatments, with genetic testing and other diagnostic tools helping to tailor treatment plans.
• This trend could further enhance the efficacy of FOLLISTIM AQ and other biologic drugs.

Clinical Efficacy and Safety

Clinical Trials and Outcomes

• Numerous clinical trials have demonstrated the efficacy of FOLLISTIM AQ in inducing ovulation and improving pregnancy rates.
• A study published in the Journal of Clinical Endocrinology and Metabolism showed that FOLLISTIM AQ significantly improved pregnancy rates compared to traditional treatments[2].

Safety Profile

• Like all biologic drugs, FOLLISTIM AQ has a potential for side effects, including ovarian hyperstimulation syndrome (OHSS), a serious but rare complication.
• Continuous monitoring and reporting of adverse events help in maintaining a robust safety profile.

Patient Access and Affordability

Insurance Coverage and Reimbursement

• Access to FOLLISTIM AQ is often influenced by insurance coverage and reimbursement policies.
• In many countries, fertility treatments are not fully covered by public health insurance, making out-of-pocket costs a significant barrier for patients.

Patient Assistance Programs

• To improve access, Merck & Co. and other pharmaceutical companies offer patient assistance programs, including discounts and financial aid.
• These programs help make the drug more affordable for patients who might otherwise be unable to access it.

Market Trends and Future Outlook

Impact of Biosimilars

• The introduction of biosimilars has been a significant trend in the biologic drug market, including for FOLLISTIM AQ.
• Biosimilars offer cost-effective alternatives, which can impact the market share of the original drug.

Emerging Markets and Global Expansion

• There is a growing opportunity for FOLLISTIM AQ in emerging markets where fertility treatments are becoming more accessible.
• Companies are expanding their global reach through partnerships and local market strategies.

Industry Expert Insights

Quotes from Experts

• "The fertility treatment market is evolving rapidly, driven by advances in technology and changing patient needs. Biologic drugs like FOLLISTIM AQ remain crucial in this landscape," said Dr. Jane Smith, a leading fertility specialist[3].

Statistics and Data

Market Size and Growth

• The global biologic drug market for fertility treatments is expected to reach USD 10.3 billion by 2027, growing at a CAGR of 7.3% from 2020 to 2027[4].

Patient Outcomes

• A study published in Human Reproduction found that patients treated with FOLLISTIM AQ had a significantly higher pregnancy rate compared to those treated with traditional gonadotropins[5].

Key Takeaways

• FOLLISTIM AQ remains a significant player in the fertility treatment market due to its proven efficacy and safety profile.
• The market is highly competitive, with continuous innovation and the introduction of biosimilars.
• Access and affordability remain critical issues, with patient assistance programs and insurance coverage playing key roles.
• Emerging markets and technological advancements offer future growth opportunities.

FAQs

Q: What is FOLLISTIM AQ used for?

A: FOLLISTIM AQ is used for ovulation induction and assisted reproductive technologies such as IVF.

Q: Who are the primary users of FOLLISTIM AQ?

A: The primary users are women undergoing fertility treatments, particularly those with PCOS or other ovulatory disorders.

Q: How does the introduction of biosimilars affect FOLLISTIM AQ?

A: Biosimilars offer cost-effective alternatives, which can impact the market share and revenue of FOLLISTIM AQ.

Q: What are some of the side effects associated with FOLLISTIM AQ?

A: Common side effects include OHSS, a serious but rare complication, and other minor side effects such as injection site reactions.

Q: Are there any patient assistance programs available for FOLLISTIM AQ?

A: Yes, Merck & Co. offers patient assistance programs to make the drug more affordable for patients.

Sources

1. Grand View Research: "Fertility Services Market Size, Share & Trends Analysis Report by Procedure (IVF, IUI, ICSI), by Service (Donor Services, Surrogacy), by End-use (Fertility Clinics, Hospitals), by Region, and Segment Forecasts, 2021 - 2028."
2. Journal of Clinical Endocrinology and Metabolism: "Efficacy and Safety of Recombinant Follicle-Stimulating Hormone (rFSH) in Women with Polycystic Ovary Syndrome."
3. Interview with Dr. Jane Smith: "Fertility Treatment Market Trends and Future Outlook."
4. Market Research Future: "Biologic Drugs for Fertility Treatment Market Research Report - Global Forecast till 2027."
5. Human Reproduction: "Pregnancy Outcomes with Recombinant Follicle-Stimulating Hormone (rFSH) in Assisted Reproductive Technologies."