MENOPUR Drug Profile

Summary for Tradename: MENOPUR

High Confidence Patents:	2
Applicants:	1
BLAs:	1
Drug Prices:	Drug price information for MENOPUR
Recent Clinical Trials:	See clinical trials for MENOPUR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for MENOPUR

See drug prices for MENOPUR

Recent Clinical Trials for MENOPUR

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Ferring Pharmaceuticals	Phase 1
Peter Kovacs MD	N/A
Centre Hospitalier Intercommunal Creteil	Phase 3

See all MENOPUR clinical trials

Recent Litigation for MENOPUR

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
JAZZ PHARMACEUTICALS IRELAND LIMITED v. LUPIN LTD.	2023-01-19
Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC	2021-11-10
JAZZ PHARMACEUTICALS IRELAND LIMITED v. LUPIN INC.	2021-07-28

See all MENOPUR litigation

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 MENOPUR Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Ferring Pharmaceuticals Inc.	MENOPUR	menotropins	For Injection	021663	5,618,913	2014-04-08	Company disclosures
Ferring Pharmaceuticals Inc.	MENOPUR	menotropins	For Injection	021663	5,866,538	2016-06-20	Company disclosures

3) Low Certainty: US Patents for MENOPUR 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
Ferring Pharmaceuticals Inc.	MENOPUR	menotropins	For Injection	021663	10,016,338	2033-03-11	Patent claims search
Ferring Pharmaceuticals Inc.	MENOPUR	menotropins	For Injection	021663	10,577,154	2029-05-13	Patent claims search
Ferring Pharmaceuticals Inc.	MENOPUR	menotropins	For Injection	021663	10,656,152	2029-01-29	Patent claims search
Ferring Pharmaceuticals Inc.	MENOPUR	menotropins	For Injection	021663	10,695,289	2035-10-09	Patent claims search

International Patents for MENOPUR

Country	Patent Number	Estimated Expiration
Brazil	9709845
Denmark	0921812
Philippines	25772
Yugoslavia	4188

Supplementary Protection Certificates for MENOPUR

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
SPC/GB99/045	United Kingdom		SPC/GB99/045: 20060829, EXPIRES: 20110828
C990042	Netherlands		PRODUCT NAME: INSULIN ASPART; REGISTRATION NO/DATE: EU/1/99/119/001 - EU/1/99/119/005 19990907
SZ 50/1999	Austria		PRODUCT NAME: INSULIN ASPART
99C0044	Belgium		PRODUCT NAME: INSULIN-ASPART; NAT. REGISTRATION NO/DATE: EU/1/99/119/001 19990907; FIRST REGISTRATION: CH 55045 01 19990615

MENOPUR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Biologic Drug: MENOPUR

Introduction to MENOPUR

MENOPUR, also known as menotropins, is a human-derived gonadotropin used in fertility treatments. It contains both follicle-stimulating hormone (FSH) and luteinizing hormone (LH) activity, making it a crucial component in assisted reproduction technology (ART) such as in vitro fertilization (IVF)[2].

Market Growth and Projections

The global infertility drugs market, which includes MENOPUR, is expected to grow at a significant rate. Here are some key projections:

• The global infertility drugs market is projected to reach USD 6,453.7 million by 2032, growing at a CAGR of 6.2% from 2022 to 2032[1].
• Within this market, gonadotropins like MENOPUR are expected to dominate, with an 8.2% projected CAGR, highlighting their high effectiveness in fertility treatments[1].

Competitive Landscape

MENOPUR operates in a competitive market dominated by a few key players:

• Ferring Pharmaceuticals’ MENOPUR, EMD Serono’s Gonal-F, and Merck’s Follistim collectively account for over 50% of the market share in the female infertility drug market[3].
• The competitive landscape is characterized by strong brand performance and limited new entrants, which has helped MENOPUR maintain its market position[3].

Financial Performance

MENOPUR has contributed significantly to Ferring Pharmaceuticals' financial performance:

• In 2022, MENOPUR generated sales of around 753 million euros, contributing to Ferring's total 2021 revenues of 2.16 billion euros, which rose by 14% over the previous year at constant exchange rates[4].
• The reproductive medicine segment, led by MENOPUR, saw a 27% growth in sales over the last two years, indicating strong market demand[4].

Cost and Efficacy

MENOPUR has demonstrated both cost and efficacy benefits compared to other treatments:

• Studies presented at the European Society of Human Reproduction and Embryology (ESHRE) have shown that MENOPUR offers considerable cost savings and higher clinical pregnancy and live birth rates compared to recombinant FSH (rFSH) treatments like Gonal-F[2].
• The average IVF costs per person using MENOPUR were lower than those using rFSH, with MENOPUR remaining cost-saving even when all cost input variables were varied[2].

Distribution Channels

MENOPUR is distributed through various channels, each contributing to its market presence:

• Hospital Pharmacies: Hospital pharmacies hold a significant market share, with an expected CAGR of 8.9%. This segment is crucial for MENOPUR's distribution[1][3].
• Online and Retail Pharmacies: These channels are also growing, providing convenient access to fertility medications and further driving the sales of MENOPUR[3].

Challenges and Opportunities

Despite its strong market position, MENOPUR faces some challenges and opportunities:

• Supply Chain Disruptions: In 2022, Ferring Pharmaceuticals halted global shipments of MENOPUR due to changes in the manufacturing process by a third-party supplier. This pause, although temporary, highlights the potential risks associated with supply chain disruptions[4].
• Generic Competition: While MENOPUR's brand strength and clinical efficacy have helped it maintain its market position, the market is not immune to generic competition, which could impact overall market dynamics[3].
• Research and Development: Continuous research and development in infertility treatments present opportunities for growth. Collaborations and innovations can lead to new market opportunities and further solidify MENOPUR's position[3].

Financial Assistance Programs

To make MENOPUR more accessible, Ferring Pharmaceuticals offers several financial assistance programs:

• HeartTomorrow: For elective egg freezing.
• Heart for Heroes: For veterans and their spouses.
• HeartBeat: For fertility preservation prior to cancer treatment.
• These programs help alleviate medication expenses, making MENOPUR more affordable for those in need[5].

Regional Performance

MENOPUR's performance is not limited to one region but is part of a global strategy:

• North America: This region is significant for MENOPUR, driven by high demand for fertility treatments. The launch and growth of various fertility medicines in this region continue to drive growth[3].
• Global Expansion: MENOPUR also sees growth in other international markets, contributing to its global financial trajectory[3].

Key Takeaways

• Market Growth: The global infertility drugs market, including MENOPUR, is expected to grow at a CAGR of 6.2% from 2022 to 2032.
• Financial Performance: MENOPUR has contributed significantly to Ferring Pharmaceuticals' revenue, with sales of around 753 million euros in 2022.
• Cost and Efficacy: MENOPUR offers both cost savings and higher clinical pregnancy and live birth rates compared to rFSH treatments.
• Distribution Channels: Hospital pharmacies and online/retail pharmacies are key distribution channels for MENOPUR.
• Challenges and Opportunities: Supply chain disruptions and generic competition are challenges, while continuous research and development present opportunities.

FAQs

Q: What is the projected CAGR for the global infertility drugs market? A: The global infertility drugs market is projected to grow at a CAGR of 6.2% from 2022 to 2032[1].

Q: How does MENOPUR compare to recombinant FSH treatments in terms of cost and efficacy? A: MENOPUR offers considerable cost savings and higher clinical pregnancy and live birth rates compared to recombinant FSH treatments like Gonal-F[2].

Q: What are the main distribution channels for MENOPUR? A: Hospital pharmacies and online/retail pharmacies are the main distribution channels for MENOPUR[1][3].

Q: What financial assistance programs are available for MENOPUR? A: Ferring Pharmaceuticals offers several financial assistance programs, including HeartTomorrow, Heart for Heroes, and HeartBeat, to make MENOPUR more affordable[5].

Q: How has MENOPUR contributed to Ferring Pharmaceuticals' financial performance? A: MENOPUR generated sales of around 753 million euros in 2022 and contributed to Ferring's total 2021 revenues of 2.16 billion euros, which rose by 14% over the previous year[4].

Sources

1. Market.us: Infertility Drugs Market Size, Outlook | CAGR 6.2% [https://market.us/report/infertility-drugs-market/]
2. Ferring.com: New data demonstrates both cost and efficacy benefit of MENOPUR® compared to recombinant FSH treatment [https://www.ferring.com/new-data-demonstrates-both-cost-and-efficacy-benefit-of-menopur-compared-to-recombinant-fsh-treatment/]
3. DrugPatentWatch.com: When do the patents on FOLLISTIM expire, and when will biosimilar versions be available? [https://www.drugpatentwatch.com/p/biologics/tradename/FOLLISTIM]
4. FiercePharma: Ferring halts all shipments of flagship fertility drug Menopur after third-party supplier changes manufacturing process [https://www.fiercepharma.com/manufacturing/ferring-halts-all-shipments-its-flagship-fertility-drug-menopur-after-third-party]
5. Alto.com: Fertility Affordability | Alto Pharmacy [https://www.alto.com/fertility-affordability]