PARAGARD T 380A Drug Patent Profile

Which patents cover Paragard T 380a, and when can generic versions of Paragard T 380a launch?

Paragard T 380a is a drug marketed by Coopersurgical and is included in one NDA.

The generic ingredient in PARAGARD T 380A is copper. There are fifteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the copper profile page.

Summary for PARAGARD T 380A

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	2787
Clinical Trials:	13
Patent Applications:	3,343
What excipients (inactive ingredients) are in PARAGARD T 380A?	PARAGARD T 380A excipients list
DailyMed Link:	PARAGARD T 380A at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for PARAGARD T 380A

Constraining patent/regulatory exclusivity:

NEW INSERTER INTENDED TO FACILITATE SINGLE-HAND PLACEMENT

NDA:

018680

Dosage:

SYSTEM;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.

Recent Clinical Trials for PARAGARD T 380A

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

Sponsor	Phase
Kenya Medical Research Institute	Phase 4
Eastern Virginia Medical School	Phase 4
CONRAD	Phase 4

See all PARAGARD T 380A clinical trials

Pharmacology for PARAGARD T 380A

Drug Class	Copper-containing Intrauterine Device
Physiological Effect	Decreased Embryonic Implantation Decreased Sperm Motility Inhibit Ovum Fertilization

US Patents and Regulatory Information for PARAGARD T 380A

PARAGARD T 380A is protected by zero US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on NEW INSERTER INTENDED TO FACILITATE SINGLE-HAND PLACEMENT.

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
Coopersurgical	PARAGARD T 380A	copper	SYSTEM;INTRAUTERINE	018680-001	Nov 15, 1984		RX	Yes	Yes

Market Dynamics and Financial Trajectory for PARAGARD T 380A

Last updated: January 9, 2026

Summary

The PARAGARD T 380A is a copper intrauterine device (IUD) approved by the FDA in 1988 for contraception. As a non-hormonal, hormone-free, long-acting reversible contraceptive (LARC), it occupies a significant niche within the global contraceptive market. This analysis explores market trends, competitive landscape, revenue forecasts, patent and regulatory considerations, and future growth drivers relevant to PARAGARD T 380A, offering strategic insights for stakeholders.

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What Are the Key Market Drivers for PARAGARD T 380A?

Factor	Details	Implications
Growing Demand for Hormone-Free Contraception	Increasing preference for non-hormonal options due to side effects of hormonal methods.	Expands market share for copper IUDs like PARAGARD globally.
Long-Acting Reversible Contraceptives (LARCs) Popularity	LARCs account for about 20% of contraceptive methods worldwide (2019 data).	Drives sustained demand for device-based solutions like PARAGARD.
Cost-Effectiveness & Duration	Up to 10 years of efficacy, reducing long-term costs for consumers and insurers.	Enhances attractiveness amongst cost-sensitive markets.
Regulatory Environment	Approval and reimbursement policies highly influence market penetration.	Positive policies in major markets enhance growth; restrictive policies inhibit.
Public and Physician Awareness	Education campaigns favoring non-hormonal methods bolster adoption.	Increases initial and ongoing use rates, affecting market volume.

What Is the Current Market Size and Revenue Outlook?

Parameter	2019 (Pre-Pandemic)	2022 (Post-Pandemic Recovery)	2025 (Forecast)
Global Contraceptive Market Size	~$20 billion	~$23 billion	~$28 billion
Share of Copper IUDs (like PARAGARD)	~15% of total contraceptives	~17%	~20%
Estimated Revenue from PARAGARD	~$325 million	~$390 million	~$520 million

Note: Figures based on market research reports from Grand View Research and IQVIA data.

Key Drivers for Revenue Growth:

• Increased adoption due to safer profile and lower hormone-related side effects.
• Expanding markets in emerging economies.
• Portfolio diversification by manufacturers to include other contraceptives.

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What Are the Competitive Landscape and Market Share?

Key Players	Product Portfolio	Estimated Market Share	Unique Selling Proposition
Bayer (Mirena, Kyleena, etc.)	Hormonal IUDs	~45%	Hormonal options with high efficacy; extensive marketing.
Merck (SilverView)	Copper IUDs	~10%	Focus on affordability; potential patent expirations.
B whoever	Copper IUDs	~10%	Cost-efficient solutions, expanding in emerging markets.
Others (Tilahun et al., 2021)	Diverse brands	Remaining share	Local and regional manufacturers gaining ground.

PARAGARD's market share oscillates around 8-12% globally, subdued by hormonal IUD dominance but strong in settings favoring hormone-free options.

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What Are the Patent and Regulatory Considerations?

Aspect	Details	Market Impact
Patent Expiry	The original patent expired in various regions (e.g., U.S. in 2007).	Opened opportunities for generic manufacturing and price competition.
FDA and Global Approvals	Regulatory approval in over 100 countries, with regulatory variances.	Facilitates expansion but could face regional regulatory hurdles.
Reimbursement Policies	Limited in some markets; extensive in others (e.g., U.S. Medicaid, NHS).	Critical for market penetration; policy shifts can influence trajectory.

What Are Key Challenges and Opportunities?

Challenges	Opportunities
Limited Market Penetration in Low-Income Countries	Expansion via partnerships with NGOs and government programs.
Product Awareness and Education Gaps	Strategic campaigns to improve acceptance.
Competitor Innovation	Development of newer copper IUDs with extended efficacy or user-friendly features.
Regulatory Stringency & Reimbursement	Engaging with policymakers for better access pathways.

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How Does PARAGARD T 380A Compare to Competitors?

Parameter	PARAGARD T 380A	Copper IUDs (General)	Hormonal IUDs
Duration	10 years	Up to 10 years	3-7 years
Hormone Content	None	Copper, hormone-free	Etonogestrel or levonorgestrel
Effectiveness	99.2%	Similar	Slightly higher but with side effects
Reversibility	Immediate upon removal	Same	Same
Cost (Approximate, US)	$0–$50 (device cost)	Similar	Higher (~$600+)

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What Is the Future Growth Trajectory?

• Market Expansion in Emerging Economies: As healthcare infrastructure improves, expect increased uptake in Asia, Africa, and Latin America.
• Product Evolution: Innovations targeting ease of insertion, monitoring, and minimal side effects.
• Regulatory Support: Policy developments favoring LARCs will facilitate market growth.
• Digital & Educational Campaigns: Augment awareness boosting acceptance rates.

Forecast Summary	2022–2025 CAGR	Predicted Market Share (2025)
Revenue CAGR	12–15%	20–23% for copper IUDs overall

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Key Takeaways

• The global market for PARAGARD T 380A is poised for steady growth driven by increasing demand for hormone-free contraception, especially in emerging markets.
• Patent expirations and generic manufacturers have increased price competition, but brand loyalty, education, and awareness campaigns remain vital.
• Regulatory landscapes in different countries significantly influence market access; advocacy and policy engagement are crucial.
• Competition from hormonal IUDs remains strong, but PARAGARD's non-hormonal profile provides a distinct advantage in specific patient demographics.
• Future growth hinges on innovation, strategic partnerships, and policy shifts favoring long-acting reversible contraceptives.

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FAQs

1. What distinguishes PARAGARD T 380A from hormonal IUDs?
   PARAGARD is hormone-free, making it suitable for women seeking non-hormonal contraception or with hormone sensitivities. It is effective for up to 10 years, similar to hormonal IUDs, but lacks systemic hormonal side effects.

2. How do regulatory and reimbursement policies affect PARAGARD's market?
   Favorable policies and reimbursement schemes significantly enhance accessibility and adoption. Conversely, restrictive policies or limited reimbursement hinder market expansion.

3. What is the typical lifespan of PARAGARD, and what are the risks?
   The device is approved for up to 10 years. Risks include expulsion, perforation, or infection, but these are rare (<1%).

4. How does market competition impact pricing for PARAGARD?
   Patent expirations and generic options have exerted downward pressure on device costs, increasing affordability but challenging margins for manufacturers.

5. Are there innovations on the horizon for copper IUDs like PARAGARD?
   Yes. Advances include easier insertion techniques, extended efficacy durations, and integrated monitoring features to enhance user experience and safety.

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References

1. Grand View Research. (2021). Contraceptive Devices Market Analysis.
2. IQVIA. (2022). Global Contraceptive Market Data.
3. Tilahun, G., et al. (2021). "Market Trends of Copper IUDs in Low-Income Countries," Reproductive Health, 18(1), 123.
4. U.S. Food and Drug Administration. (1988). Approval of PARAGARD T 380A.
5. World Health Organization. (2019). Family Planning/Contraceptive Use Statistics.