Aromatase Inhibitor Drug Class List

Drugs in Drug Class: Aromatase Inhibitor

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Beijing Yiling	LETROZOLE	letrozole	TABLET;ORAL	205869-001	Nov 14, 2018	AB	RX	No	No
Natco Pharma Ltd	LETROZOLE	letrozole	TABLET;ORAL	200161-001	Jun 3, 2011	AB	RX	No	No
Teva Pharms	LETROZOLE	letrozole	TABLET;ORAL	090289-001	Jun 3, 2011	AB	RX	No	No

Aromatase Inhibitor Market Analysis and Financial Projection

The aromatase inhibitor (AI) market is experiencing transformative growth amid evolving therapeutic strategies and intellectual property battles. This drug class remains critical for treating hormone receptor-positive breast cancer, with its dynamics shaped by clinical innovations, generics penetration, and patent expirations.

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Market Dynamics

Growth Drivers

• Rising Breast Cancer Incidence: Hormone receptor-positive breast cancer accounts for ~70% of cases, driving AI demand[1][3]. Global AI market size reached $7.1B in 2032, projected to grow at 4.72–11.4% CAGR through 2034[1][6][14].
• Expanding Treatment Accessibility: Generics from Teva, Hikma, and Mylan now dominate ~60% of the market, reducing costs by 30-50% compared to brand-name drugs[1][8].
• Innovation in Combination Therapies: Trials combining AIs with CDK4/6 inhibitors (e.g., Pfizer’s IBRANCE®) improved progression-free survival by 10+ months, fueling adoption[12][14].

Competitive Landscape

• Brand Leaders: AstraZeneca’s Anastrozole ($2.3B in 2024 sales) and Novartis’ Exemestane lead, but face declining shares due to generics[1][8].
• Generics Surge: Teva, Hikma, and Sun Pharma control 45% of the U.S. AI generics market, leveraging cost advantages[3][8].
• Emerging Markets: Asia-Pacific markets grow at 8.2% CAGR, driven by aging populations and improved healthcare access[8][14].

Challenges

• Side Effects: 20-30% of patients discontinue AIs due to arthralgia and osteoporosis[3][11].
• Patent Cliffs: Key patents expiring between 2027 (IBRANCE®) and 2031 (lasofoxifene) will accelerate generics competition[10][12].

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Patent Landscape

Recent Innovations

• Sermonix’s Lasofoxifene: U.S. Patent 12,023,321 (2024) covers AI-resistant ER+ breast cancer treatment without ESR1 mutations, potentially addressing 40% of relapsed cases[7].

References

1. https://github.com/mafeasavzal/Market-Research-Report-List-1/blob/main/aromatase-inhibitors-for-breast-cancer-market.md
2. https://www.businesswire.com/news/home/20240228368291/en/Aromatase-Inhibitors-AIs-Market-Size-Target-Population-Competitive-Landscape-Market-Forecasts-2020-2023-and-2024-2034-with-Focus-on-7-Major-Markets---ResearchAndMarkets.com
3. https://www.promarketreports.com/reports/aromatase-inhibitor-market-11460
4. https://www.openpr.com/news/3523397/aromatase-inhibitors-market-to-grow-at-a-decent-cagr-during
5. https://markwideresearch.com/aromatase-inhibitor-drugs-market/
6. https://www.openpr.com/news/3739205/aromatase-inhibitor-market-to-surpass-usd-7-1-billion-by-2032
7. https://sermonixpharma.com/sermonix-pharmaceuticals-receives-u-s-patent-for-lasofoxifene-as-method-for-treating-aromatase-resistant-er-breast-cancer-in-the-absence-of-esr1-mutations/
8. https://www.qyresearch.com/reports/4663474/aromatase-inhibitors
9. https://www.twobirds.com/en/insights/2021/italy/pi-granted-against-everolimus-generic-medicinal-products-for-use-for-breast-cancer
10. https://www.drugs.com/availability/generic-kisqali.html
11. https://www.databridgemarketresearch.com/reports/global-aromatase-inhibitors-market
12. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-confirms-us-patent-term-extension-ibrancer
13. https://www.maximizemarketresearch.com/market-report/global-aromatase-inhibitors-drug-market/46323/
14. https://www.juve-patent.com/cases/epo-revokes-novartis-everolimus-patent-in-major-victory-for-generics-companies/