Copper-containing Intrauterine Device Drug Class List

Drugs in Drug Class: Copper-containing Intrauterine Device

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Coopersurgical	PARAGARD T 380A	copper	SYSTEM;INTRAUTERINE	018680-001	Nov 15, 1984		RX	Yes	Yes

Copper-containing Intrauterine Device Market Analysis and Financial Projection

The copper-containing intrauterine device (IUD) market is experiencing dynamic growth, driven by technological advancements, shifting consumer preferences, and strategic patent innovations. Here's an in-depth analysis of the market dynamics and intellectual property landscape:

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Market Overview

The global copper IUD market is projected to grow from $3.0 billion in 2021 to $4.4 billion by 2031, with a 3.8% CAGR [3]. Alternative estimates suggest a rise from $1.5 billion (2019) to $2.2 billion by 2025 (5.4% CAGR) [6], reflecting regional variations and expanded access in developing economies. Key market segments include:

• Age groups: 25–34-year-olds dominate usage (30% market share) [6], driven by demand for long-term contraception.
• Geography: North America leads (35–40% share) [3], while Asia-Pacific shows rapid growth due to government family-planning initiatives [6][9].

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Growth Drivers

1. Non-Hormonal Preference: 44% of women prioritize hormone-free options, avoiding side effects like weight gain or mood swings [9].
2. Cost-Effectiveness: Copper IUDs cost 60–70% less than hormonal alternatives over a 10-year period [7][11].
3. Emergency Contraception: 99% efficacy when inserted within 5 days of unprotected sex [7].
4. Policy Support: WHO and UNFPA programs aim to reduce unintended pregnancies, which affect 47 million women annually [1].

Factor	Impact
LARC adoption	100% increase in U.S. IUD usage since 2015 [11]
STI prevention	30% of users cite reduced STI anxiety [6]
Postpartum use	22% uptake within 6 weeks of delivery [7]

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Challenges

• Side Effects: 40% of users report heavier menstrual bleeding [7], though newer designs aim to reduce this.
• Access Barriers: Only 15% of rural clinics in low-income countries stock IUDs [13].
• Misconceptions: 28% of women incorrectly associate IUDs with infertility [13].

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Patent Landscape

Recent innovations focus on bleeding control and targeted copper release:

Key Patents:

Patent (Year)	Innovation	Impact
WO2014090976A1 (2014)	Combines copper with selective progesterone receptor modulators (SPRMs) like ulipristal acetate	Reduces bleeding by 50% while maintaining contraceptive efficacy [2]
WO2012063262A2 (2012)	Biodegradable polymer coating for controlled copper ion elution	Lowers expulsion risk by 30% [5]
US10188546 (2019)	Galvanic frame material (nitinol) paired with copper sleeves	Enables 99% efficacy with 175 mm² copper vs. traditional 380 mm² [12]

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Recent Innovations

1. Miudella® (2025 FDA Approval):

   • First new copper IUD in the U.S. in 40 years [4][10].
   • Uses nitinol frame for flexible placement and <50% copper of legacy devices [8].
   • 3-year efficacy: 1.05 Pearl Index (27,115 exposure cycles) [8].

2. Polymer-Coated Models:

   • Slow-release copper IUDs (e.g., TCu 380A) reduce cramping by 40% [12].

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Competitive Landscape

• Leaders: Teva (Paragard®), Bayer, Merck [6].
• Emerging Players: Sebela Pharmaceuticals (Miudella®) [10], EurimPharm [6].
• R&D Focus:
  • Shape-memory alloys to prevent uterine perforation [11].
  • Frameless designs (e.g., GyneFix®) for nulliparous women [7].

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Future Outlook

1. Emerging Markets: Asia-Pacific to account for 50% of growth through 2030 [6], fueled by India’s National Family Health Mission.
2. Personalized IUDs: Phase II trials for hormone-copper hybrids targeting endometriosis patients [2].
3. Sustainability: Recyclable copper components projected to reduce device costs by 20% by 2028 [5].

“Miudella’s approval marks a paradigm shift in non-hormonal contraception, addressing both efficacy and tolerability concerns.” – David K. Turok, MD [8][10].

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This evolving landscape underscores copper IUDs' critical role in global reproductive health, balancing innovation with accessibility to meet diverse patient needs.

References

1. https://www.mordorintelligence.com/industry-reports/intrauterine-contraceptive-devices-iud-market
2. https://patents.google.com/patent/WO2014090976A1/en
3. https://www.alliedmarketresearch.com/intrauterine-devices-market-A10999
4. https://www.drugtopics.com/view/fda-approves-first-non-hormonal-copper-iud-in-over-40-years
5. https://patents.google.com/patent/WO2012063262A2/en
6. https://www.datainsightsmarket.com/reports/intrauterine-device-with-copper-1011963
7. https://en.wikipedia.org/wiki/Copper_IUD
8. https://www.empr.com/news/new-copper-iud-miudella-approved-for-pregnancy-prevention/
9. https://sites.google.com/view/surveycraft/market-dynamics/intrauterine-device-with-copper-market-by-application
10. https://www.biospace.com/press-releases/fda-approves-miudella-the-first-hormone-free-copper-intrauterine-system-ius-in-the-u-s-in-over-40-years-from-sebela-womens-health-inc
11. https://www.grandviewresearch.com/industry-analysis/intrauterine-devices-market-report
12. https://patents.justia.com/patent/10188546
13. https://www.verifiedmarketreports.com/product/copper-iuds-market/
14. https://larcprogram.ucsf.edu/obtaining-supplies