FOLLISTIM AQ CARTRIDGE Drug Profile

Summary for Tradename: FOLLISTIM AQ CARTRIDGE

High Confidence Patents:	4
Applicants:	1
BLAs:	1

Pharmacology for FOLLISTIM AQ CARTRIDGE

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 FOLLISTIM AQ CARTRIDGE Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for FOLLISTIM AQ CARTRIDGE 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		2015-06-16	Company disclosures
Organon Usa Llc, A Subsidiary Of Organon & Co.	FOLLISTIM AQ CARTRIDGE	follitropin beta	Injection	021211		2017-01-15	Company disclosures
Organon Usa Llc, A Subsidiary Of Organon & Co.	FOLLISTIM AQ CARTRIDGE	follitropin beta	Injection	021211		2018-07-23	Company disclosures
Organon Usa Llc, A Subsidiary Of Organon & Co.	FOLLISTIM AQ CARTRIDGE	follitropin beta	Injection	021211		2018-07-23	Company disclosures

3) Low Certainty: US Patents for FOLLISTIM AQ CARTRIDGE 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 Llc, A Subsidiary Of Organon & Co.	FOLLISTIM AQ CARTRIDGE	follitropin beta	Injection	021211		2033-03-11	Patent claims search
Organon Usa Llc, A Subsidiary Of Organon & Co.	FOLLISTIM AQ CARTRIDGE	follitropin beta	Injection	021211		2024-12-29	Patent claims search
Organon Usa Llc, A Subsidiary Of Organon & Co.	FOLLISTIM AQ CARTRIDGE	follitropin beta	Injection	021211		2029-05-13	Patent claims search
Organon Usa Llc, A Subsidiary Of Organon & Co.	FOLLISTIM AQ CARTRIDGE	follitropin beta	Injection	021211		2029-01-29	Patent claims search
Organon Usa Llc, A Subsidiary Of Organon & Co.	FOLLISTIM AQ CARTRIDGE	follitropin beta	Injection	021211		2037-01-05	Patent claims search
Organon Usa Llc, A Subsidiary Of Organon & Co.	FOLLISTIM AQ CARTRIDGE	follitropin beta	Injection	021211		2038-07-09	Patent claims search
Organon Usa Llc, A Subsidiary Of Organon & Co.	FOLLISTIM AQ CARTRIDGE	follitropin beta	Injection	021211			Patent claims search

International Patents for FOLLISTIM AQ CARTRIDGE

Country	Patent Number	Estimated Expiration
European Patent Office	0211894
Hong Kong	143295
Spain	2183486
European Patent Office	0160699
European Patent Office	0160091
Colombia	5090905
Germany	69813322

Supplementary Protection Certificates for FOLLISTIM AQ CARTRIDGE

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
10C0024	France		PRODUCT NAME: CORIFOLLITROPINE ALPHA; REGISTRATION NO/DATE: EU/1/09/609/001 20100125
96C0010	Belgium		PRODUCT NAME: HORMONE FOLLICO-STIMULANTE, HUMAINE RECOMBINANTE; NAT. REGISTRATION NO/DATE: D 13156 19951020; FIRST REGISTRATION: FI - 713/845/94 19940815

FOLLISTIM AQ CARTRIDGE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for FOLLISTIM AQ Cartridge

Introduction to FOLLISTIM AQ Cartridge

FOLLISTIM AQ Cartridge, developed by Organon USA, is a recombinant follicle-stimulating hormone (FSH) used in fertility treatments, particularly in assisted reproductive technology (ART) programs and for the induction of ovulation in anovulatory infertile patients. This medication is administered via the FOLLISTIM Pen, a user-friendly, pre-mixed cartridge system that eliminates the need for reconstitution[1][4][5].

Market Position and Competitiveness

Unique Selling Points

• The FOLLISTIM AQ Cartridge stands out due to its pre-mixed formulation, which does not require reconstitution, making it more convenient and accurate compared to traditional lyophilized preparations. This convenience, combined with the precision of the FOLLISTIM Pen, results in an 18% higher delivery of follitropin beta[1][3][5].
• The pen injection device allows for fine-tune dosing in 25 IU increments, enhancing patient compliance and reducing the risk of dosing errors.

Market Share and Growth

• FOLLISTIM AQ Cartridge is a leading recombinant FSH product in the U.S., particularly within the fertility segment of Organon's Women's Health division. The product has contributed significantly to the company's revenue growth in this sector[2].

Financial Performance

Revenue Contribution

• In the second quarter of 2021, Organon reported a 19% increase in revenue from its Women's Health segment, with FOLLISTIM AQ Cartridge being a key contributor to this growth. The total net revenue for Organon was $1,595 million, with Women's Health segment revenue reaching $417 million[2].

Cost and Gross Margin

• The gross margin for Organon in the second quarter of 2021 was 63.4% as-reported and 65.5% on an adjusted basis. However, this represented a year-over-year decrease due to increased stand-up costs and manufacturing agreements with lower gross margin percentages[2].

Market Trends and Drivers

Increasing Demand for Fertility Treatments

• The demand for fertility treatments, including ART procedures, has been on the rise due to factors such as delayed childbearing and increasing awareness of fertility options. This trend has positively impacted the sales of FOLLISTIM AQ Cartridge[2].

Technological Advancements

• The innovative design of the FOLLISTIM Pen, which includes features like a magnification dose window and audible dosage clicks, has enhanced patient compliance and satisfaction. Such technological advancements continue to drive the market for this product[5].

Challenges and Risks

Side Effects and Safety Concerns

• Like all gonadotropins, FOLLISTIM AQ Cartridge carries risks such as ovarian hyperstimulation syndrome (OHSS) and multiple gestations. These risks necessitate careful patient selection and monitoring by experienced physicians[1][4][5].

Regulatory and Market Competition

• The fertility treatment market is highly competitive, with several other FSH products available. Regulatory changes and market competition can impact the sales and market share of FOLLISTIM AQ Cartridge[2].

Patient Support and Access Programs

Financial Assistance

• Organon collaborates with programs like ReUnite Rx to provide financial assistance to eligible self-paying patients, helping to make FOLLISTIM AQ Cartridge more accessible despite its costs[5].

Pharmacokinetics and Clinical Efficacy

Pharmacokinetic Parameters

• Studies have shown that the FOLLISTIM AQ Cartridge administered via the FOLLISTIM Pen results in higher serum FSH concentrations compared to conventional syringe and needle methods. The elimination half-life of follitropin beta from the cartridge is approximately 33.4 hours[4].

Clinical Indications

• FOLLISTIM AQ Cartridge is indicated for the development of multiple follicles in ovulatory patients undergoing ART and for the induction of ovulation in anovulatory infertile patients. It is also used to stimulate ovarian follicular growth in women without primary ovarian failure[4].

Conclusion

FOLLISTIM AQ Cartridge has established itself as a leading product in the fertility treatment market, driven by its convenience, accuracy, and clinical efficacy. The financial performance of this product reflects its strong market position and the growing demand for fertility treatments.

Key Takeaways

• Convenience and Accuracy: FOLLISTIM AQ Cartridge offers a pre-mixed, ready-to-use formulation that enhances patient compliance and reduces dosing errors.
• Market Growth: The product has contributed significantly to Organon's revenue growth in the Women's Health segment.
• Financial Performance: Despite some year-over-year decreases in gross margin, the product remains a key revenue driver.
• Safety and Efficacy: It is crucial to monitor patients for potential side effects like OHSS and to ensure the product is used under the guidance of experienced physicians.
• Patient Support: Financial assistance programs are available to help make the treatment more accessible.

FAQs

Q: What is the primary advantage of using FOLLISTIM AQ Cartridge over traditional FSH preparations?

A: The primary advantage is its pre-mixed formulation, which eliminates the need for reconstitution and provides more accurate dosing through the FOLLISTIM Pen.

Q: How does the FOLLISTIM Pen enhance patient compliance?

A: The pen features a magnification dose window, audible dosage clicks, and the ability to adjust doses in 25 IU increments, making it easier for patients to administer the correct dose.

Q: What are the potential side effects of FOLLISTIM AQ Cartridge?

A: Potential side effects include ovarian hyperstimulation syndrome (OHSS) and multiple gestations. Patients must be carefully monitored by experienced physicians.

Q: Is FOLLISTIM AQ Cartridge indicated for all types of infertility?

A: No, it is indicated for the development of multiple follicles in ovulatory patients undergoing ART and for the induction of ovulation in anovulatory infertile patients without primary ovarian failure.

Q: Are there any financial assistance programs available for patients using FOLLISTIM AQ Cartridge?

A: Yes, Organon collaborates with programs like ReUnite Rx to provide financial assistance to eligible self-paying patients.

Sources

1. Organon USA Release: Follistim(R) AQ Cartridge, The First Pre-mixed Fertility Treatment FSH in the U.S. Now Available in 900 IU Presentation[1].
2. Organon Reports Results for the Second Quarter Ended June 30, 2021, and Announces Inaugural Dividend[2].
3. Follistim AQ FOLLITROPIN 975 [iU]/1.17mL Merck Sharp & Dohme LLC[3].
4. Follistim® AQ Cartridge - accessdata.fda.gov[4].
5. FOLLISTIM® AQ Cartridge (follitropin beta injection) Official Site[5].