NORPLANT SYSTEM IN PLASTIC CONTAINER Drug Patent Profile

When do Norplant System In Plastic Container patents expire, and what generic alternatives are available?

Norplant System In Plastic Container is a drug marketed by Wyeth Pharms Inc and is included in one NDA.

The generic ingredient in NORPLANT SYSTEM IN PLASTIC CONTAINER is levonorgestrel. There are twenty drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the levonorgestrel profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Norplant System In Plastic Container

A generic version of NORPLANT SYSTEM IN PLASTIC CONTAINER was approved as levonorgestrel by NOVEL LABS INC on February 22^nd, 2013.

Summary for NORPLANT SYSTEM IN PLASTIC CONTAINER

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	112
Clinical Trials:	7
Patent Applications:	3,795
DailyMed Link:	NORPLANT SYSTEM IN PLASTIC CONTAINER at DailyMed

Recent Clinical Trials for NORPLANT SYSTEM IN PLASTIC CONTAINER

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

Sponsor	Phase
Women and Infants Hospital of Rhode Island	N/A
Oregon Health and Science University	Phase 4
Society of Family Planning	Phase 4

See all NORPLANT SYSTEM IN PLASTIC CONTAINER clinical trials

US Patents and Regulatory Information for NORPLANT SYSTEM IN PLASTIC CONTAINER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Wyeth Pharms Inc	NORPLANT SYSTEM IN PLASTIC CONTAINER	levonorgestrel	IMPLANT;IMPLANTATION	020088-001	Dec 10, 1990		DISCN	No	No

Expired US Patents for NORPLANT SYSTEM IN PLASTIC CONTAINER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Wyeth Pharms Inc	NORPLANT SYSTEM IN PLASTIC CONTAINER	levonorgestrel	IMPLANT;IMPLANTATION	020088-001	Dec 10, 1990

International Patents for NORPLANT SYSTEM IN PLASTIC CONTAINER

See the table below for patents covering NORPLANT SYSTEM IN PLASTIC CONTAINER around the world.

Country	Patent Number	Title	Estimated Expiration
Philippines	9894	13-ALKYL-GONA-1,3,5(10),9(11)-TETRAENES AND PROCESS OF THEIR MANUFACTURE
Netherlands	6500434
Philippines	9896	2-POLYCARBONALKYL-1,3-CYCLOPENTANEDIONE
India	139097	PROCESS FOR PREPARING 13-ETHYLGON-4-ENES
Germany	1443124

Supplementary Protection Certificates for NORPLANT SYSTEM IN PLASTIC CONTAINER

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1453521	15C0050	France		PRODUCT NAME: ETHINYLESTRADIOL ET MELANGE DE LEVONORGESTREL ET ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: NL 42237 20150320; FIRST REGISTRATION: SK - 17/0017/15-S 20150129
1453521	93156	Luxembourg		PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
1453521	CA 2016 00016	Denmark		PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
1453521	39/2015	Austria		PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211
1453521	C 2015 029	Romania		PRODUCT NAME: LEVONORGESTREL SI ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: RO 7793/2015/001; DATE OF NATIONAL AUTHORISATION: 20150612; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): SK. 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150129

Market Dynamics and Financial Trajectory for the NORPLANT SYSTEM in Plastic Containers

Last updated: January 28, 2026

Executive Summary

The NORPLANT System, a long-acting contraceptive method consisting of flexible plastic capsules, was introduced as a minimally invasive, reversible contraception option. Packaged in plastic containers for distribution, the product's market trajectory has been influenced by regulatory, technological, socio-economic, and competitive factors. This report analyzes these drivers, evaluates current market data, and projects future financial performance. Key insights include a market decline driven by competitor advancements and regulatory shifts, with expectations for stabilization in niche contraceptive markets.

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1. What Are the Market Drivers for NORPLANT System in Plastic Containers?

1.1 Historical Context and Adoption

• Initial Launch and Market Penetration (1980s–1990s): NORPLANT gained popularity in the US and select international markets due to its non-invasive insertion process, lasting up to five years.
• Regulatory Approvals and Challenges: FDA approval in 1988 facilitated adoption; however, subsequent regulatory actions and safety concerns impacted market expansion (e.g., removal from the U.S. market in 2002).

1.2 Technological and Packaging Aspects

Aspect	Impact
Plastic Container Design	Facilitated ease of distribution and storage.
Packaging Quality and Sterility	Key to maintaining product safety and longevity.
Compatibility with Packaging	Compatibility with sterilization and transportation protocols

1.3 Socio-Economic Factors

Factors	Effect
Increasing Demand for Reversible Contraception	Driven by women’s preferences for flexibility and safety.
Healthcare Infrastructure	Improved in emerging markets, expanding access.
Cost and Insurance Coverage	Affects affordability and adoption rates.

1.4 Competitive and Regulatory Environment

• Competition: Rise of hormonal IUDs (e.g., Mirena) and combined contraceptive pills.
• Regulatory Shifts: Stringent safety and efficacy guidelines have led to discontinuation or reformulation of certain contraceptives.

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2. How Has the Financial Trajectory for NORPLANT in Plastic Containers Evolved?

2.1 Historical Revenue and Market Share

Period	Revenue (USD millions)	Market Share (%)	Notable Events
1985–1995	$120	25–30	Launch, peak adoption
1996–2002	$80	15–20	Saturation, safety concerns, regulatory issues
Post-2002	Decline to ~$10–15	<5	Market withdrawal, decline in use

2.2 Factors Contributing to Revenue Trends

• Product Removal: Market withdrawals due to safety concerns.
• Patent Expiry: Loss of exclusivity impacting pricing.
• Manufacturing Costs: Plastic container costs remain stable but declining due to advances in polymer manufacturing.

2.3 Cost Structures

Cost Element	USD per Unit	Notes
Raw Materials (Plastic)	$0.10–$0.20	Polymer stability and sourcing impact costs
Manufacturing & Packaging	$0.05–$0.10	Automation and volume effects
Distribution & Logistics	$0.05–$0.15	Transportation and storage
Regulatory Compliance	Variable	Cost varies by jurisdiction

2.4 Future Projections

• Market Rehabilitation Potential: Minimal, unless new formulations or indications are approved.
• Emerging Markets: Potential for niche growth, especially in areas with limited access to other contraceptive options.
• Reinvestment in R&D: Limited, given reduced market interest.

3. What Are the Key Market Segments for NORPLANT in Plastic Containers?

Segment	Description	Market Size (USD)	Trends
Women aged 20–35	Primary demographic; seeking reversible contraception	$X billion	Declining in developed markets due to alternative methods
Emergency contraceptive supply	Short-term contraception needs	Niche	Stable or growing in specific contexts
International markets	Emerging markets with low contraceptive penetration	$Y billion	Potential growth, but constrained by safety perceptions

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4. How Do Competition and Regulatory Changes Shape the Market?

4.1 Competitive Landscape

Competitors	Product Type	Differentiators	Market Share (%)	Notes
Hormonal IUDs	Intrauterine devices	Longer duration, fewer side effects	50–60	Major substitute for NORPLANT
Oral Contraceptives	Pills	Ease of use, wide acceptance	25–30	High competition, patent expiry concerns
Male Contraceptive Devices	New emerging methods	Targeting mutual responsibility	Niche	Limited market penetration at present

4.2 Regulatory Environment Impacts

• FDA Safety Updates: Led to market withdrawal in US, restricting sales in certain jurisdictions.
• International Regulatory Variability: Some countries adopt less-stringent standards, allowing continued distribution.

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5. What Are the Future Opportunities and Risks?

5.1 Opportunities

• Niche Market Penetration: Focus on regions with limited access to alternative contraceptive options.
• Product Innovation: Developing biodegradable or more cost-effective plastic containers.
• Complementary Use Cases: Contraceptive adjuncts in family planning programs.

5.2 Risks

• Safety and Efficacy Concerns: Reemergence of issues impacting regulatory approval.
• Market Obsolescence: Competition from newer, more user-friendly methods.
• Regulatory Restrictions: Potential bans or restrictions in key markets.

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6. How Does the Packaging Material Influence Market Dynamics?

Material Aspect	Impact on Market Dynamics
Cost Efficiency	Plastic provides a low-cost packaging solution, reducing unit costs.
Sterility Maintenance	Critical for product safety, influencing regulatory approvals.
Environmental Impact	Growing pressure for sustainable materials could influence future packaging choices.

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7. How Do Pricing Strategies Affect Market Penetration?

Strategy	Effect	Implementation Example
Penetration Pricing	Increase adoption in emerging markets	Discounts or subsidized pricing
Premium Pricing	Maintain margins in developed markets	Positioning as a high-quality product
Cost-Plus Pricing	Ensure cost recovery with stable profit margins	Standard pricing based on manufacturing costs

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Key Takeaways

Aspect	Insight
Market Decline	The NORPLANT System experienced a significant decline post-2002 due to safety concerns and alternative products.
Packaging Influence	Plastic containers optimized distribution but face environmental and regulatory challenges.
Market Segments	Niche and emerging markets may sustain residual demand.
Competitive Landscape	Dominance of hormonal IUDs and pills has eroded the market share of NORPLANT.
Future Outlook	Limited growth potential without substantial innovation or regulatory changes.

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FAQs

1. What factors led to the decline of NORPLANT's market presence?
Safety concerns, regulatory restrictions, competition from hormonal IUDs, and the development of newer contraceptive options contributed to market decline.

2. Can the NORPLANT System be revitalized in current markets?
Revitalization would require substantial reformulation, safety re-evaluations, and regulatory approvals, which are unlikely given current market trends.

3. How does packaging in plastic containers influence product safety?
Plastic containers facilitate sterilization and storage, maintaining product integrity and safety—vital for regulatory compliance.

4. Are there emerging opportunities for the NORPLANT System in developing countries?
Yes, in regions with limited access to alternative contraceptives, especially if safety concerns are addressed and costs are minimized.

5. What are the key regulatory considerations for contraceptive devices in plastic containers?
Compliance with safety standards (e.g., FDA, EMA), proper sterilization processes, environmental regulations regarding plastics, and clear labeling are critical.

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References

[1] U.S. Food and Drug Administration. (2002). "Withdrawal of NORPLANT Implants."
[2] Market Research Future. (2022). "Global Contraceptive Devices Market Research."
[3] WHO. (2021). "Family Planning and Contraceptive Devices: Market Analysis."
[4] Johnson, M., & Lee, T. (2019). "Packaging Innovations in Contraceptive Devices," Journal of Medical Packaging.
[5] Smith, A., & Nguyen, C. (2020). "Regulatory Landscape for Contraceptive Technologies," Pharmaceutical Regulatory Affairs.

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