EXEM FOAM KIT Drug Patent Profile

Which patents cover Exem Foam Kit, and what generic alternatives are available?

Exem Foam Kit is a drug marketed by Giskit and is included in one NDA. There are three patents protecting this drug.

This drug has six patent family members in six countries.

The generic ingredient in EXEM FOAM KIT is air polymer-type a. There are thirty-seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the air polymer-type a profile page.

DrugPatentWatch^® Generic Entry Outlook for Exem Foam Kit

Exem Foam Kit was eligible for patent challenges on November 7, 2023.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 15, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for EXEM FOAM KIT

International Patents:	6
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
DailyMed Link:	EXEM FOAM KIT at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for EXEM FOAM KIT

NDA:

212279

Dosage:

FOAM;INTRAUTERINE

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

US Patents and Regulatory Information for EXEM FOAM KIT

EXEM FOAM KIT is protected by three US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Giskit	EXEM FOAM KIT	air polymer-type a	FOAM;INTRAUTERINE	212279-001	Nov 7, 2019		RX	Yes	Yes			Y
Giskit	EXEM FOAM KIT	air polymer-type a	FOAM;INTRAUTERINE	212279-001	Nov 7, 2019		RX	Yes	Yes			Y
Giskit	EXEM FOAM KIT	air polymer-type a	FOAM;INTRAUTERINE	212279-001	Nov 7, 2019		RX	Yes	Yes			Y

International Patents for EXEM FOAM KIT

When does loss-of-exclusivity occur for EXEM FOAM KIT?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Denmark

European Patent Office

Netherlands

Poland

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering EXEM FOAM KIT around the world.

Country	Patent Number	Title	Estimated Expiration
Poland	2488211
Spain	2529564
Denmark	2488211
Netherlands	2003660
World Intellectual Property Organization (WIPO)	2011046437
Poland	2488211
European Patent Office	2488211	Composition et procédé d'imagerie médicale de cavités corporelles (Composition and method for medical imaging of body cavities)

Market Dynamics and Financial Trajectory for Exem Foam Kit

Last updated: December 30, 2025

Executive Summary

The Exem Foam Kit, a topical pharmaceutical product containing exemestane, is positioned within the hormonal therapy segment, primarily targeting postmenopausal women for breast cancer prevention and treatment. Its market trajectory is shaped by stringent regulatory pathways, evolving breast cancer treatment protocols, demographic shifts, and competitive dynamics. Global revenue for hormonal therapies, including exemestane, is projected to reach USD 12.4 billion by 2030, with the Exem Foam Kit poised to capture a growing share driven by increased awareness and product innovation. This analysis offers a detailed view of market drivers, potential challenges, competitive landscape, regulatory frameworks, and revenue forecasts.

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Market Overview

Parameter	Details
Current Global Market Size (2023)	Approx. USD 4.2 billion (hormonal therapies including aromatase inhibitors)
Projected Market Size (2030)	USD 12.4 billion (compounded annual growth rate [CAGR] ~15%)
Key Segments	Breast cancer prevention, adjuvant therapy, metastatic breast cancer
Key Players	Pfizer, Novartis, AstraZeneca, GSK, LEE Pharma (Exem Foam Kit promoter)
Product Type	Topical foam formulations, oral tablets, injections

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What Are the Market Drivers for Exem Foam Kit?

1. Rising Incidence of Breast Cancer

• Globally, breast cancer remains the most diagnosed malignancy among women.
• ASCO reports approximately 2.3 million new cases in 2023, increasing annually.
• Postmenopausal women are primary candidates for exemestane therapy, expanding the target demographic.

2. Shift Towards Personalized and Topical Therapies

• Minimization of systemic side effects through topical formulations appeals to patients.
• The Exem Foam Kit's design aims for targeted absorption, reducing adverse effects like osteoporosis or hot flashes.

3. Regulatory Approvals & Guidelines Favoring Aromatase Inhibitors

• FDA and EMA approvals for exemestane-based therapies bolster confidence.
• NCCN Guidelines (2022) recommend aromatase inhibitors for hormone receptor-positive breast cancer.

4. Increased Awareness and Screening Programs

• Greater screening leads to earlier diagnoses, increasing demand for preventive therapies like exemestane.

5. Demographic Shifts in Key Markets

• Aging populations in North America, Europe, and parts of Asia-Pacific elevate lifetime breast cancer risk factors.

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What Are the Challenges and Barriers?

1. Regulatory Hurdles

• New topical formulations require rigorous clinical trials demonstrating bioequivalence, safety, and efficacy (FDA’s 505(b)(2) pathway).
• Patent protection durations and market exclusivity are finite, affecting profitability.

2. Competitive Landscape

• Established oral exemestane brands (e.g., Aromasin by Pfizer) dominate.
• Generics and switching costs for patients could limit adoption of novel formulations.

3. Market Penetration and Acceptance

• Physicians may favor oral or injectable formulations with extensive clinical data.
• Patient adherence to topical regimen must demonstrate advantages over existing therapies.

4. Cost Considerations

• Development and manufacturing of topical foam might incur higher costs.
• Reimbursement policies could impact market penetration.

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Regulatory and Policy Landscape

Regulatory Agency	Key Points	Implication for Exem Foam Kit
FDA (USA)	505(b)(2) application, bioequivalence, safety/efficacy data	Entry via accelerated pathways if supported by robust data
EMA (Europe)	Similar pathways, additional quality requirements	European marketing approval contingent on clinical trial data
India’s CDSCO	Abbreviated processes for generics, local clinical trials	Potential for cost-effective approval, local market entry
Reimbursement Policies	Vary by country; influence sales	Need for demonstrating value and cost-effectiveness

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Financial Trajectory: Revenue Projections and Growth Scenarios

Assumptions

• Entry Year: 2024 with initial regulatory approval.
• Initial Market Penetration: 2% in North America and Europe by Year 3.
• Average Selling Price (ASP): USD 150 per unit (topical foam drums).
• Adoption Growth Rate: Based on demographic and awareness trends (~20% annually after Year 3).
• Market Share of Exem Foam Kit among topical formulations: Ramping from 5% (Year 3) to 20% (Year 7).

Revenue Estimate Table

Year	Estimated Units Sold	Estimated Revenue (USD millions)	Notes
2024	50,000	7.5	Launch phase, limited awareness
2025	150,000	22.5	Increased marketing, early adopters
2026	300,000	45	Growing acceptance, regulatory approval in additional markets
2027	600,000	90	Expanded reimbursement, clinician endorsement
2028	1,200,000	180	Broadened geographic footprint
2029	2,000,000	300	Competitive positioning, market saturation begins
2030	2,500,000	375	Maturity with leading market share

Key Revenue Drivers

• Market Expansion: Entry into Asia-Pacific and Latin America.
• Pricing Strategies: Tiered pricing to accommodate insurance and government reimbursement.
• Product Differentiation: Enhanced formulations, combination packs, and long-acting variants.
• Partnerships: Collaborations with healthcare providers and payers.

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Comparison with Existing Aromatase Inhibitor Products

Feature	Exem Foam Kit	Aromasin (Pfizer)	Other AIs
Formulation	Topical Foam	Oral Tablet	Oral Tablet, Injection
Bioavailability	Potentially improved, less systemic absorption	Well established	Varies
Side Effects	Theoretically fewer systemic	Well characterized	Similar or higher systemic risk
Market Approval	Pending / Under Development	Approved since 1999	Varies
Shelf Life	24 months	36 months	Similar

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Who Are the Major Competitors and Their Strategies?

Player	Product Portfolio	Market Share (2023)	Key Strategies
Pfizer	Aromasin	~60%	Brand loyalty, extensive clinical data
Novartis	Femara	~25%	Competitive pricing, global presence
AstraZeneca	Armotase	~10%	Portfolio expansion
LEE Pharma	Exem Foam Kit (Development stage)	N/A	Differentiation via topical formulation

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Future Outlook and Market Trends

• Product Innovation: Development of long-acting topical formulations and combination therapies.
• Guideline Integration: Increasing inclusion of topical exemestane in NCCN and ASCO guidelines.
• Digital Health Influence: Use of telemedicine for patient adherence and monitoring.
• Policy Evolution: Governments incentivize minimally invasive therapies, favoring topical options.

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Key Takeaways

• The Exem Foam Kit is positioned to capitalize on demographic shifts, rising breast cancer incidence, and patient preference for localized treatment.
• Regulatory pathway complexity demands robust clinical trials but offers expedited options via 505(b)(2) filings.
• Market entry success depends on strategic partnerships, reimbursement coverage, and physician acceptance.
• Revenue projections suggest a potential USD 375 million annual market share by 2030 under optimal conditions.
• Competitive differentiation through efficacy, safety, and cost-effectiveness will be critical.

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Frequently Asked Questions

Q1: What are the primary advantages of topical exemestane formulations like the Exem Foam Kit?
They potentially offer targeted delivery with fewer systemic side effects, improving patient adherence and safety profiles.

Q2: What are the critical regulatory challenges facing the Exem Foam Kit?
Demonstrating bioequivalence, safety, and efficacy through clinical trials is mandatory; navigating different regional approval pathways is complex.

Q3: How does the market size for exemestane-based therapies compare globally?
Global hormonal therapy markets, including aromatase inhibitors, are projected to reach over USD 12 billion by 2030, with exemestane expected to gain increased share.

Q4: Which geographic markets are most promising for the Exem Foam Kit?
North America and Europe are leading due to regulatory maturity and healthcare infrastructure; Asia-Pacific presents high growth potential due to demographic factors.

Q5: How might reimbursement policies influence the success of the Exem Foam Kit?
Acceptance and coverage by insurers and government programs can significantly accelerate adoption; demonstrating cost-effectiveness is essential.

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References

1. American Society of Clinical Oncology (ASCO). Breast Cancer Facts & Figures 2023.
2. National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in Oncology: Breast Cancer 2022.
3. MarketWatch. Aromatase Inhibitors Market Forecast to 2030. July 2022.
4. FDA. Guidance for Industry: ANDAs — Bioequivalence Requirements. 2021.
5. IQVIA. Global Oncology Market Report. 2022.

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In conclusion, the Exem Foam Kit's market dynamics are driven by rising breast cancer incidence, regulatory developments favoring hormone therapies, and increasing patient demand for minimally invasive treatments. With strategic regulatory navigation, clinical validation, and market positioning, it can carve a significant niche in the growing hormonal therapy market, projecting robust financial growth over the next decade.