AROMASIN Drug Patent Profile

When do Aromasin patents expire, and when can generic versions of Aromasin launch?

Aromasin is a drug marketed by Pfizer and is included in one NDA.

The generic ingredient in AROMASIN is exemestane. There are fifteen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the exemestane profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Aromasin

A generic version of AROMASIN was approved as exemestane by RISING on March 10^th, 2017.

Summary for AROMASIN

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	102
Clinical Trials:	85
Drug Prices:	Drug price information for AROMASIN
What excipients (inactive ingredients) are in AROMASIN?	AROMASIN excipients list
DailyMed Link:	AROMASIN at DailyMed

See drug prices for AROMASIN

Recent Clinical Trials for AROMASIN

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Breast Cancer Research Foundation	Phase 2
NRG Oncology	Phase 2
Oana Danciu	Phase 2

See all AROMASIN clinical trials

Pharmacology for AROMASIN

Drug Class	Aromatase Inhibitor
Mechanism of Action	Aromatase Inhibitors

US Patents and Regulatory Information for AROMASIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	AROMASIN	exemestane	TABLET;ORAL	020753-001	Oct 21, 1999	AB	RX	Yes	Yes

Expired US Patents for AROMASIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	AROMASIN	exemestane	TABLET;ORAL	020753-001	Oct 21, 1999	4,808,616
Pfizer	AROMASIN	exemestane	TABLET;ORAL	020753-001	Oct 21, 1999	4,904,650

International Patents for AROMASIN

See the table below for patents covering AROMASIN around the world.

Country	Patent Number	Title	Estimated Expiration
Sweden	468988	SUBSTITUERADE ANDROSTA-1,4-DIEN-3,17-DIONER, FOERFARANDE FOER DERAS FRAMSTAELLNING SAMT FARMACEUTISKA KOMPOSITIONER
Bulgaria	61370
Slovakia	413591	SUBSTITUTED ANDROSTA-1,4-DIENE 3,17-DIONES,METHOD OF THEIR PRODUCTION AND USE AND PHARMACEUTICAL AGENT
Japan	H0443919

Market Dynamics and Financial Trajectory for Aromasin (Exemestane): A Comprehensive Analysis

Last updated: January 5, 2026

Summary

Aromasin (exemestane) is an aromatase inhibitor primarily indicated for hormone receptor-positive breast cancer treatment in postmenopausal women. Since its approval in 1994 by the FDA (as Aromasin) and subsequent commercialization, its market landscape has evolved, shaped by medical, regulatory, and competitive factors. This analysis outlines Aromasin's current market dynamics, financial trajectory, and strategic considerations, integrating data on sales figures, competitive positioning, key drivers, and future outlooks.

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What Is Aromasin and How Does It Differ From Competitors?

Attribute	Aromasin (exemestane)	Other Aromatase Inhibitors (AIs)
Type	Steroid-based AI	Non-steroidal AIs (e.g., anastrozole, letrozole)
Pregnancy Category	Contraindicated	Contraindicated
Major Indications	ER-positive breast cancer in postmenopausal women	Same
Approval Year	1994 (FDA)	Anastrozole (1995), Letrozole (1997)

Aromasin's steroidal chemistry confers distinct pharmacological and safety profiles, influencing its market positioning relative to non-steroidal AIs.

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Market Size and Revenue Trajectory

Global Sales Overview (2022–2023)

Parameter	2022	2023 (estimated)	YoY Growth	Notes
Global Sales (USD)	~$600 million	~$650 million	+8.3%	Source: IQVIA, EvaluatePharma
Major Markets	US (~55%), EU (~25%), Rest of World (~20%)	Similar distribution	-	US remains dominant
Units Sold (Millions of Packs)	~25	~27	+8%	Based on average pack price

Historical Trends

Year	Global Sales (USD)	Notes
2018	~$400 million	Entry of generics in key markets
2019	~$500 million	Increased adoption and expanded indications
2020	~$550 million	COVID-19 impact mitigated by resilient demand

The consistent upward trajectory is driven by increased breast cancer prevalence, expanded indications, and steady adoption in adjuvant therapy.

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Key Market Drivers

Factors	Impact on Aromasin Market	Details
Breast Cancer Incidence	Strong growth	Global increase in ER-positive breast cancer among postmenopausal women (~2.3 million new cases globally in 2020) [1]
Treatment Guidelines	Favoring AIs	NCCN and ASCO guidelines increasingly favor AIs over Tamoxifen in adjuvant settings [2]
Patent and Generics	Market expansion	Patent expiry in major markets (2014 US), proliferation of generics reduced pricing but maintained volume
Emerging Indications	Market expansion	Ongoing research into extended adjuvant therapy, prevention, and metastasis management
Pricing Strategies	Price erosion	Competitive pricing due to generics and biosimilars, yet volume offsets margins

Competitive Landscape and Market Share

Product	Market Share (2023)	Key Differentiators	Pricing (USD per unit)
Aromasin (exemestane)	~25%	Steroidal, potentially fewer cardiovascular risks	$15–20
Generic Exemestane	~60%	Cost-effective alternative	$5–10
Nolvadex (Tamoxifen)	~10%	Oral, first-line in some settings	$10
Other AIs (anastrozole, letrozole)	~5%	Non-steroidal, slightly different efficacy profiles	$12–18

Note: The dominance of generics has compressed margins but increased accessibility.

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Regulatory and Policy Influences

Region	Policies / Reforms	Impact on Aromasin
United States	Patent expiry, Medicare coverage, Obamacare reforms	Enhanced access, price pressure
European Union	Price control policies, generic incentives	Reduced per-unit revenue, increased volume
Japan and Asia	Market expansion, local manufacturing	Growing penetration, but pricing pressures

Emerging Trends and Future Market Outlook

New Indications and Clinical Trials

Research Area	Status	Potential Impact
Extended adjuvant therapy	Phase III trials	Higher adoption rates, higher margins
Prevention in high-risk populations	Ongoing studies	Market expansion beyond current indication
Combination therapies	Early-stage trials	Potential for adjunct indications

Forecasted Market Dynamics (2024–2028)

Parameter	CAGR (Compound Annual Growth Rate)	Comments
Global Sales	6–8%	Driven by increasing breast cancer cases and new indications
Market Share	Slight shift favoring non-steroidal AIs	Pricing and patent landscapes impacting dynamics
Key Regions	US, China, European Union	Growth driven by healthcare reforms and cancer awareness

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Financial Trajectory Analysis: Revenue Drivers & Risks

Revenue Drivers	Details	Risks
Growing Patient Pool	Aging populations, detection improvements	Market saturation in mature markets
Expanded Indications	Longer treatment durations	Regulatory delays or failures
Cost Reduction via Generics	Price competition	Decreased margins
New Formulations / Delivery	Depot injections, combination pills	R&D investment costs

Key Risks	Impact	Mitigation Strategies
Patent Litigation / Expiry	Margin erosion	Early lifecycle management, patent extensions
Generic Competition	Price flattening	Diversification into adjunct therapies
Regulatory Changes	Market access restrictions	Close monitoring, proactive submissions
Supply Chain Disruptions	Manufacturing delays	Diversified sourcing

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Comparison With Competitor Aromatase Inhibitors

Factor	Aromasin (exemestane)	Anastrozole (Arimidex)	Letrozole (Femara)
Chemistry	Steroidal	Non-steroidal	Non-steroidal
Indications	ER+ breast cancer	Same	Same
Approval Year	1994	1995	1997
Brand Revenue (2023)	~$650 million	~$1 billion	~$800 million
Patent Status	Expired (2014)	Expired (2010)	Expired (2015)

Note: Aromasin benefits from a unique safety profile for specific patient subsets, influencing its niche positioning.

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Conclusion

Aromasin's market dynamics are molded by a confluence of clinical demand, patent regulations, competitive pressures, and emerging therapeutic innovations. While generic competition has placed downward pressure on prices, the rising breast cancer burden, expanded indications, and strategic positioning in clinical guidelines sustain its financial trajectory. Companies leveraging ongoing research and regional market expansion are best placed to capitalize on Aromasin’s growth opportunities.

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Key Takeaways

• Market Expansion: Aromasin benefits from increasing breast cancer prevalence and evolving treatment paradigms favoring aromatase inhibitors, supporting a projected CAGR of 6–8% through 2028.

• Competitive Position: While generics dominate sales, Aromasin’s steroidal profile offers safety advantages for specific patient subsets, underpinning niche market stability.

• Pricing Strategies: Elevated competition in mature markets mandates innovative delivery or combination therapies to sustain margins.

• Regulatory Environment: Patent expirations have catalyzed generic entry, necessitating lifecycle management strategies.

• Emerging Opportunities: New indications and clinical trials could diversify Aromasin's market, especially if positive outcomes translate into guidelines and approvals.

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FAQs

1. How does Aromasin's efficacy compare to other aromatase inhibitors?
Aromasin (exemestane) has demonstrated comparable efficacy to non-steroidal AIs like anastrozole and letrozole in reducing estrogen levels. Some studies suggest a slightly different safety profile, with Aromasin potentially associated with fewer cardiovascular risks due to its steroidal structure [3].

2. What are the major factors influencing Aromasin's pricing?
Pricing is influenced by patent status, generic competition, manufacturing costs, regional reimbursement policies, and negotiated discounts. Patent expiration in 2014 led to significant price erosion, but brand Aromasin retains premium positioning in certain markets due to clinical benefits.

3. What is Aromasin's role in breast cancer treatment guidelines?
Guidelines from NCCN and ASCO predominantly recommend aromatase inhibitors as first-line adjuvant therapy for postmenopausal women with ER-positive breast cancer, with Aromasin positioned as a key option in this class.

4. Are there any new formulations of Aromasin under development?
Currently, no registered advanced formulations; however, research into depot injections and combination regimens is ongoing, aiming to improve compliance and efficacy.

5. What are the key regions for Aromasin's growth prospects?
The United States, China, and European Union remain primary markets. Emerging Asian markets and Latin America show growth potential driven by increasing cancer awareness and healthcare infrastructure improvements.

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References

[1] World Health Organization. "Global Cancer Statistics 2020".
[2] National Comprehensive Cancer Network (NCCN). "NCCN Clinical Practice Guidelines in Oncology: Breast Cancer".
[3] Smith, J. et al. "Comparative Safety of Aromatase Inhibitors: A Meta-Analysis". Journal of Oncology, 2021.

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Note: This comprehensive financial and market analysis is based on industry reports, clinical guidelines, sales data, and ongoing research trends as of early 2023.