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. One supplier is 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:	2869
Clinical Trials:	13
Patent Applications:	1,976
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
CONRAD	Phase 4
United States Agency for International Development (USAID)	Phase 4
Kenya Medical Research Institute	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

PARAGARD T 380A Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of PARAGARD T 380A

Introduction

The PARAGARD T 380A, a copper-bearing intrauterine device (IUD), has been a significant player in the long-term contraceptive market since its initial U.S. approval in 1984. Here, we will delve into the market dynamics and financial trajectory of this product.

Market Position and Demand

PARAGARD T 380A is one of the most popular non-hormonal, long-term contraceptive options available. It is designed to provide up to 10 years of contraception, making it an attractive choice for women seeking effective and low-maintenance birth control[3][4].

Competitive Landscape

The contraceptive market is diverse, with various types of birth control methods available, including hormonal IUDs, oral contraceptives, and barrier methods. However, PARAGARD T 380A holds a unique position as a non-hormonal IUD, appealing to women who prefer or require hormone-free contraception. Its effectiveness, with a pregnancy rate of less than 1 per 100 women per year, further solidifies its market standing[1][3].

Regulatory Environment

The regulatory environment for PARAGARD T 380A has been relatively stable, with the device being approved for use in the U.S. since 1984. However, recent legal challenges and lawsuits have introduced some volatility. The device is subject to strict guidelines for insertion and removal, which must be performed by healthcare professionals experienced with these procedures[1][4].

Legal Challenges and Lawsuits

In recent years, PARAGARD T 380A has been embroiled in numerous lawsuits alleging defective design and failure to warn users about the risks associated with the device, particularly during removal. These lawsuits claim that the device can break or fracture, leading to serious injuries such as uterine perforation, chronic pain, and the need for invasive surgeries. As of December 2024, the number of active cases in the multidistrict litigation (MDL) has grown to 2,862[2][5].

Financial Impact of Lawsuits

The ongoing lawsuits have significant financial implications for the manufacturers, Teva Pharmaceuticals and CooperSurgical. The costs associated with defending these lawsuits, potential settlements, and damages could impact the financial trajectory of the product. Additionally, the negative publicity from these lawsuits may affect consumer confidence and demand for the device[2][5].

Ownership and Manufacturing Changes

In 2017, CooperSurgical acquired PARAGARD from Teva Pharmaceuticals in a deal worth approximately $1.1 billion. This change in ownership could influence the product's market strategy and financial performance. However, the transition has not been without challenges, as indicated by the ongoing legal issues[5].

Revenue and Market Share

Despite the legal challenges, PARAGARD T 380A remains a profitable product due to its long-term effectiveness and the demand for non-hormonal contraceptive options. The exact revenue figures are not publicly disclosed, but the device's market share in the IUD segment is substantial. The acquisition by CooperSurgical was likely driven by the product's financial potential and its established market presence[5].

Consumer and Healthcare Provider Perception

Consumer perception of PARAGARD T 380A is mixed. While many women appreciate its effectiveness and convenience, others have reported adverse reactions and complications, particularly during removal. Healthcare providers must carefully weigh the benefits and risks when recommending this device to patients. The need for thorough counseling and follow-up care is emphasized in the prescribing information to mitigate potential issues[1][3].

Future Outlook

The future outlook for PARAGARD T 380A is complex. On one hand, the device's effectiveness and demand for non-hormonal contraception are likely to sustain its market presence. On the other hand, the ongoing legal challenges and potential financial liabilities could impact its profitability and market share. The manufacturers will need to address these issues proactively to maintain consumer and healthcare provider trust.

Key Takeaways

• Market Position: PARAGARD T 380A is a leading non-hormonal IUD with a strong market presence.
• Legal Challenges: Ongoing lawsuits related to device removal complications pose significant financial and reputational risks.
• Financial Trajectory: The product remains profitable but faces potential financial impacts from lawsuits and settlements.
• Consumer Perception: Mixed, with both positive and negative experiences reported.
• Future Outlook: The device's future is influenced by its effectiveness, legal issues, and the manufacturers' ability to address these challenges.

Frequently Asked Questions (FAQs)

Q: What is the mechanism of action of PARAGARD T 380A? A: The copper in PARAGARD T 380A interferes with sperm transport and fertilization of an egg and possibly prevents implantation[1][3].

Q: How long does PARAGARD T 380A provide contraception? A: PARAGARD T 380A provides contraception for up to 10 years[1][3].

Q: What are the common adverse reactions associated with PARAGARD T 380A? A: Common adverse reactions include bleeding, cramps, anemia, and vasovagal reactions. Serious complications can occur during removal, such as device breakage and uterine perforation[1][3].

Q: Who are the current manufacturers of PARAGARD T 380A? A: CooperSurgical acquired PARAGARD from Teva Pharmaceuticals in 2017[5].

Q: What is the current status of the lawsuits against PARAGARD T 380A? A: As of December 2024, there are 2,862 active cases in the multidistrict litigation (MDL) related to complications during device removal[5].

Sources:

1. FDA Label: ParaGard T380A Intrauterine Copper Contraceptive - [PDF]
2. TorHoerman Law: Paragard Lawsuit - [Website]
3. eMPR: PARAGARD T380A Prescription & Dosage Information - [Website]
4. DailyMed: PARAGARD T 380A- copper intrauterine device - [Website]
5. Motley Rice: Paragard Lawsuit - [Website]