List of Excipients in Branded Drug PARAGARD T 380A

Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Teva Women's Health LLC	PARAGARD T 380A	copper	51285-204	BARIUM SULFATE	2027-06-28
Teva Women's Health LLC	PARAGARD T 380A	copper	51285-204	POLYETHYLENE GLYCOL	2027-06-28
CooperSurgical Inc	PARAGARD T 380A	copper	59365-5128	BARIUM SULFATE	2027-06-28
CooperSurgical Inc	PARAGARD T 380A	copper	59365-5128	POLYETHYLENE GLYCOL	2027-06-28
CooperSurgical Inc	PARAGARD T 380A	copper	59365-5129	BARIUM SULFATE	2027-06-28
CooperSurgical Inc	PARAGARD T 380A	copper	59365-5129	POLYETHYLENE GLYCOL	2027-06-28

PARAGARD T 380A Excipient Strategy, Patent Position, and Commercial Opportunities

Last updated: September 8, 2026

PARAGARD T 380A is a copper-bearing intrauterine contraceptive device, not a conventional pharmaceutical. Its commercial protection depends on device regulation, material specifications, manufacturing know-how, clinical evidence, trademarks, and distribution rather than excipient exclusivity or Orange Book listings. The primary opportunity is to improve the device platform around copper geometry, insertion safety, packaging, sterilization, and patient access without compromising the approved product’s biocompatibility or contraceptive performance.

What is PARAGARD T 380A made of?

PARAGARD T 380A contains no pharmacologically inactive excipients in the conventional tablet, capsule, injectable, or biologic sense. It is a polymer-and-metal medical device.

Component	Role	Commercial or IP relevance
Polyethylene frame	Provides the T-shaped structure and supports the copper components	Polymer grade, molding process, dimensional control, and mechanical strength
Copper wire and copper sleeves	Provide the contraceptive copper surface, with a nominal total copper surface area of about 380 mm²	Copper purity, wire diameter, winding, surface area, release profile, and corrosion behavior
Barium sulfate, where specified in the frame material	Radiopaque additive that allows visualization by X-ray	Formulation control, dispersion, imaging performance, and biocompatibility
Polyethylene removal strings	Permit removal of the device	Fiber strength, knot retention, visibility, and tissue compatibility
Inserter assembly	Delivers the device through the cervix and uterine cavity	Ergonomics, sterility, deployment reliability, packaging, and user training

The copper is the active contraceptive material. The device is designed to release copper ions locally in the uterus, producing a sperm-inhibitory and inflammatory environment that prevents fertilization. The product does not rely on a soluble drug payload, hormone reservoir, coating, or controlled-release polymer matrix [1].

Does PARAGARD use pharmaceutical excipients?

No. A conventional excipient strategy is not applicable to PARAGARD in the same way it applies to an oral drug. The relevant materials strategy involves:

• Medical-grade polyethylene selection
• Copper purity and surface-area control
• Copper-polymer bonding or mechanical retention
• Radiopacity
• Removal-string performance
• Sterilization compatibility
• Packaging-barrier integrity
• Particulate and extractables control
• Long-term dimensional stability

This distinction affects competitive analysis. A company seeking to commercialize a similar product would generally pursue a medical-device pathway and a device-materials strategy, not an abbreviated new drug application based on pharmaceutical excipient equivalence.

What is the FDA regulatory status of PARAGARD T 380A?

PARAGARD T 380A is an FDA-approved Class III medical device regulated through the premarket approval pathway. Its approval is associated with PMA P890026 and subsequent supplements and labeling updates [2].

The current commercial product is associated with CooperSurgical. CooperSurgical acquired the Paragard business from Teva Pharmaceutical Industries in 2017 [3]. The product is indicated for prevention of pregnancy for up to 10 years, according to the current U.S. prescribing information [1].

Regulatory issue	PARAGARD status
Product category	Copper intrauterine contraceptive device
U.S. pathway	Premarket approval
FDA product type	Class III medical device
Active mechanism	Local copper ion activity
Hormone content	None
U.S. approval holder and commercial supplier	CooperSurgical-associated Paragard business
Orange Book listing	None
Paragraph IV pathway	Not applicable
Biosimilar pathway	Not applicable
Conventional generic-drug pathway	Not applicable

What is the Orange Book status of PARAGARD?

PARAGARD is not listed in the FDA Orange Book because the Orange Book covers approved drug products, not PMA-approved intrauterine devices. Its absence from the Orange Book does not indicate that the product lacks legal protection. Protection may arise from patents, regulatory records, trademarks, trade secrets, manufacturing controls, clinical data, and supplier relationships.

Does PARAGARD have new-drug exclusivity?

PARAGARD does not receive the standard five-year new chemical entity exclusivity associated with a new pharmaceutical active ingredient. Its commercial position is based primarily on PMA approval, device-specific evidence, market access, brand recognition, manufacturing capability, and any surviving patent or regulatory rights.

What patents protect PARAGARD T 380A?

The public regulatory record identifies PARAGARD as a copper IUD approved decades ago, but a complete and current patent determination requires a claim-by-claim review of U.S. and foreign patent registers, assignments, terminal disclaimers, maintenance-fee records, and litigation filings.

The core product’s practical protection is likely to be more dependent on manufacturing know-how and regulatory barriers than on a single active patent. Relevant patent categories include:

1. Copper-bearing intrauterine device architectures
2. T-shaped polymer frames
3. Copper wire winding and retention methods
4. Copper sleeves or collars on device arms
5. Inserter mechanisms
6. Sterile packaging and deployment systems
7. Manufacturing methods controlling copper surface area
8. Imaging or radiopacity features
9. Device positioning and removal features
10. Improvements designed to reduce expulsion, perforation, pain, or bleeding

Because PARAGARD entered the U.S. market in the 1980s, foundational composition and architecture patents would generally face substantial age-related expiration risk. Later patents could still cover manufacturing steps, inserter designs, packaging, or incremental structural improvements. A competitor would need to avoid active claims, not merely copy the general T-shaped copper-IUD concept.

How strong is the PARAGARD patent estate?

The product’s likely patent strength is mixed:

Protection layer	Relative strength	Reason
Foundational copper-IUD architecture	Low to moderate	Product has been marketed for decades; early patents may have expired
Brand and trademark protection	High	PARAGARD has substantial U.S. market recognition
Regulatory record and clinical evidence	High	A competing PMA product would need its own safety and effectiveness package
Manufacturing know-how	Moderate to high	Copper winding, dimensional tolerances, sterilization, and quality systems can be difficult to replicate
Inserter and packaging improvements	Variable	Depends on active claims and product-specific design
Supplier and quality-control systems	Moderate	Qualification and validation create operational barriers
International patent coverage	Variable	Depends on country, filing history, and local patent expiry

The strongest barrier for a new entrant is unlikely to be a single composition-of-matter claim. It is the combined cost and risk of producing a reliable device, generating clinical evidence, obtaining PMA approval, establishing sterile manufacturing, and building clinician adoption.

When does PARAGARD lose exclusivity?

PARAGARD has no single publicly applicable exclusivity date comparable to a small-molecule drug’s compound-patent expiry. The device can lose commercial exclusivity through several routes:

• Expiration of relevant patents
• Approval of a competing copper IUD
• A competitor’s PMA approval
• Loss of physician preference
• Product recalls or quality events
• Reimbursement changes
• Lower-cost international products entering regulated markets
• New long-acting contraceptive products taking share

The 10-year contraceptive indication is a product-use duration, not a market-exclusivity period. It means the device is labeled for pregnancy prevention for up to 10 years; it does not prevent another manufacturer from developing a competing copper IUD.

Are there Paragraph IV challenges or generic-entry risks?

There is no conventional Paragraph IV pathway for PARAGARD because the product is not an Orange Book-listed drug. A competitor would not ordinarily file an abbreviated new drug application alleging invalidity or noninfringement of listed patents.

The likely entry routes are:

Entry route	Applicability
ANDA generic	Not applicable
505(b)(2) application	Generally not the primary route for a copper IUD
PMA	Likely route for a substantially different or new Class III device
PMA supplement	Available to the existing approval holder for certain changes
Humanitarian device exemption	Potentially relevant only for a narrow disease or population indication
Foreign regulatory approval	Possible outside the U.S., subject to local device rules
Infringement litigation	Possible if a new device practices active patent claims

A competing manufacturer could face patent litigation, but its more immediate risk would be FDA review of design controls, biocompatibility, sterilization, packaging, insertion, removal, migration, breakage, expulsion, perforation, pregnancy prevention, and adverse-event monitoring.

What formulation and device-material opportunities exist?

The most attractive “excipient” opportunities are actually materials-engineering opportunities.

Polymer-frame improvements

A supplier could develop a frame material with:

• Better flexural recovery after insertion
• Lower fracture risk
• Improved radiopacity
• Reduced particulate generation
• Better compatibility with sterilization
• Controlled surface finish
• Consistent dimensional performance over long-term storage

Any material change would require compatibility testing and could require a PMA supplement or a new PMA, depending on its effect on safety and effectiveness.

Copper-surface optimization

Copper remains the core active material. Commercial opportunities include:

• More uniform copper surface area
• Better control of wire winding tension
• Improved retention of copper wire on the stem
• Reduced sharp-edge risk
• Controlled copper release over the intended use period
• Surface treatments that preserve contraceptive activity while reducing adverse reactions
• Manufacturing methods that limit copper debris or particulate release

A change that reduces copper release could weaken contraceptive performance. A change that increases release could affect tolerability, corrosion, or safety. The target is controlled local activity, not simply maximum copper loading.

Inserter redesign

The inserter is a separate commercial opportunity. Potential improvements include:

• Smaller insertion diameter
• Better depth control
• Improved deployment feedback
• Reduced risk of partial deployment
• Compatibility with varied uterine anatomy
• Easier loading and removal
• Lower plastic content
• More intuitive clinician handling

Inserter improvements can create protectable product differentiation even when the implanted copper device remains similar.

Packaging and sterilization

Sterile-barrier and logistics improvements can reduce cost and improve supply reliability. Opportunities include:

• Lower-cost validated packaging materials
• Better moisture and oxygen barriers
• Reduced package volume
• Improved shelf-life stability
• More efficient terminal sterilization
• Automated visual inspection
• Serialization and anti-counterfeiting features

These changes may have a more practical effect on gross margin than incremental changes to the copper assembly.

What commercial opportunities exist around PARAGARD?

The commercial opportunity is broader than manufacturing a competing IUD.

Contract manufacturing

A qualified manufacturer could supply:

• Copper wire
• Copper sleeves
• Molded polymer frames
• Removal strings
• Sterile inserters
• Device packaging
• Automated inspection systems

The barriers are high because medical-device customers require validated processes, traceability, lot release, and long-term supplier performance.

Platform licensing

A company with a validated copper-IUD architecture could license:

• Frame designs
• Inserter systems
• Copper-retention methods
• Manufacturing processes
• Foreign-market rights
• Combination products for specific populations

Licensing value would depend on freedom to operate, clinical evidence, regulatory status, and country-specific reimbursement.

International market expansion

Copper IUD demand is strongest where nonhormonal, long-acting contraception is accepted and healthcare systems support insertion services. A lower-cost device could compete in markets where PARAGARD is unavailable or priced above local alternatives. Local regulatory requirements, public procurement, clinician training, and adverse-event reporting would determine uptake.

Adjacent patient-access products

Commercial opportunities include:

• Clinician insertion kits
• Cervical measurement tools
• Ultrasound-assisted placement services
• Patient education programs
• Removal and replacement scheduling systems
• Insurance and reimbursement support
• Training platforms for difficult insertions

These products do not replace the IUD but can improve procedure efficiency and reduce abandonment.

How does PARAGARD compare with hormonal IUDs?

PARAGARD’s principal commercial distinction is that it contains no hormone. Hormonal IUDs release levonorgestrel and compete on bleeding reduction, duration, patient experience, and pricing.

Attribute	PARAGARD T 380A	Hormonal IUDs
Active material	Copper	Levonorgestrel
Hormone-free	Yes	No
Main contraceptive mechanism	Copper-mediated local effect	Progestin-mediated cervical mucus and endometrial effects
Typical commercial positioning	Long-acting, hormone-free contraception	Long-acting contraception with potential bleeding reduction
Key tolerability issue	Heavier or longer menstrual bleeding and cramping	Irregular bleeding, hormonal effects, and insertion-related events
Patent strategy	Device architecture, materials, manufacturing, inserter	Drug substance, reservoir, release system, device combination, and methods of use
Regulatory category	PMA medical device	Drug-device combination products

PARAGARD has a differentiated position for users seeking hormone-free contraception. Its main commercial weakness is the possibility of increased menstrual bleeding and cramping, which can drive discontinuation and substitution by hormonal products.

What patent litigation affects PARAGARD?

PARAGARD has faced product-liability litigation relating to alleged device breakage and difficult removal. Those proceedings are distinct from patent litigation. Product-liability claims can affect sales, insurance cost, physician confidence, reserve requirements, and regulatory scrutiny even when they do not challenge patent validity.

Publicly available information should not be treated as evidence that a particular competitor has successfully invalidated or licensed PARAGARD patents. The key diligence issue is to separate:

• Patent infringement claims
• Product-liability claims
• Regulatory enforcement
• Recalls
• Manufacturing disputes
• Trademark disputes
• Commercial settlements

A settlement in one category does not establish freedom to operate in another.

What generic launch scenarios exist?

Three entry scenarios are commercially realistic.

Scenario 1: No direct U.S. competitor

PARAGARD retains substantial U.S. market protection through brand recognition, PMA history, clinician familiarity, and the absence of a competing FDA-approved copper IUD.

Scenario 2: Premium competing copper IUD

A new entrant obtains PMA approval for a device with a smaller inserter, improved tolerability, longer labeled duration, or better placement control. It competes through clinical differentiation rather than price alone.

Scenario 3: Lower-cost copper IUD

A manufacturer enters through international markets or U.S. public-sector channels with a lower-cost device. Price competition pressures procurement contracts and may reduce PARAGARD’s share even without broad private-market substitution.

The highest-value differentiation areas are likely insertion experience, bleeding tolerability, device retention, clinical evidence, and cost of production.

Key Takeaways

• PARAGARD T 380A is a PMA-approved medical device, not a conventional pharmaceutical.
• It has no conventional excipient strategy; polyethylene, copper, radiopaque additives, strings, and inserter materials are the relevant components.
• The product is not listed in the Orange Book and is not subject to Paragraph IV challenges or biosimilar competition.
• Its strongest commercial barriers are regulatory evidence, manufacturing validation, clinical data, brand recognition, and supply-chain capability.
• Core architecture patents may face age-related expiration risk, while later manufacturing, inserter, packaging, or process claims require specific freedom-to-operate analysis.
• The best commercial opportunities are copper assembly, polymer-frame technology, inserter redesign, sterile packaging, contract manufacturing, international licensing, and clinician-support products.
• Hormonal IUDs are the primary commercial substitutes, while a future U.S. copper-IUD entrant would need to obtain its own FDA authorization.

FAQs

Can a company develop a generic version of PARAGARD?

Not through the ordinary ANDA pathway. A competing copper IUD would generally require its own medical-device regulatory strategy, potentially including PMA-level evidence.

Does PARAGARD contain barium sulfate?

The device frame is described as containing radiopaque material, including barium sulfate in the product description. The exact formulation and grade are controlled specifications of the approved device [1].

Is copper in PARAGARD an active pharmaceutical ingredient?

No. Copper is the active contraceptive material in a medical device. It is not an API in the conventional drug-approval sense.

Can a new copper IUD use the same 380 mm² copper surface area?

Potentially, but matching surface area alone would not establish regulatory equivalence or freedom to operate. Frame geometry, copper retention, release behavior, insertion, sterility, and clinical performance would also matter.

What is the most defensible commercial moat around PARAGARD?

The combined moat is strongest: FDA-approved clinical evidence, validated manufacturing, copper-device know-how, physician familiarity, brand recognition, distribution, and quality-system performance. No single layer should be assumed to provide perpetual exclusivity.

References

1. CooperSurgical, Inc. (n.d.). Paragard T 380A intrauterine copper contraceptive: Prescribing information. U.S. Food and Drug Administration labeling repository. https://www.accessdata.fda.gov/

2. U.S. Food and Drug Administration. (n.d.). PMDA database: Paragard T 380A, PMA P890026. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm

3. Teva Pharmaceutical Industries Ltd. (2017, September 27). Teva announces completion of sale of Paragard business to CooperSurgical. https://www.teva.com/news-and-media/press-releases/