NORPLANT Drug Patent Profile

Which patents cover Norplant, and when can generic versions of Norplant launch?

Norplant is a drug marketed by Population Council and Wyeth Pharms Inc and is included in two NDAs.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Norplant

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

Summary for NORPLANT

US Patents:	0
Applicants:	2
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	112
Clinical Trials:	7
Patent Applications:	3,796
DailyMed Link:	NORPLANT at DailyMed

Recent Clinical Trials for NORPLANT

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

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

See all NORPLANT clinical trials

US Patents and Regulatory Information for NORPLANT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Population Council	NORPLANT	levonorgestrel	IMPLANT;IMPLANTATION	019897-001	Dec 10, 1990		DISCN	No	No
Wyeth Pharms Inc	NORPLANT SYSTEM IN PLASTIC CONTAINER	levonorgestrel	IMPLANT;IMPLANTATION	020088-001	Dec 10, 1990		DISCN	No	No

Expired US Patents for NORPLANT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Population Council	NORPLANT	levonorgestrel	IMPLANT;IMPLANTATION	019897-001	Dec 10, 1990
Population Council	NORPLANT	levonorgestrel	IMPLANT;IMPLANTATION	019897-001	Dec 10, 1990

International Patents for NORPLANT

See the table below for patents covering NORPLANT around the world.

Country	Patent Number	Title	Estimated Expiration
Switzerland	565730	Steroid intermediates for total synthesis
Netherlands	6500434
United Kingdom	1116810
Netherlands	146502
Spain	288366

Supplementary Protection Certificates for NORPLANT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1453521	122015000093	Germany		PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
1453521	C201630040	Spain		PRODUCT NAME: ETINILESTRADIOL Y MEZCLA DE LEVONORGESTREL Y ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: 80340; DATE OF AUTHORISATION: 20160122; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 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	93156	Luxembourg		PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
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

Market Dynamics and Financial Trajectory for NORPLANT

Last updated: July 31, 2025

---

Introduction

NORPLANT, a subdermal hormonal contraceptive implant, was developed by OB & GYN physician Dr. Carl Djerassi and licensed to Syntex Corporation (later acquired by Roche) in the late 20th century. Approved by the U.S. Food and Drug Administration (FDA) in 1983, NORPLANT became a pioneering long-acting reversible contraceptive (LARC), symbolizing a significant shift in family planning and reproductive health markets. Its unique delivery system and market positioning generated notable revenue streams for manufacturers before facing market disruptions and evolving contraceptive preferences.

This analysis examines the market dynamics and financial trajectory associated with NORPLANT, considering historical context, competitive landscape, regulatory influences, and future outlooks.

---

Market Landscape and Growth Drivers

1. Early Adoption and Market Penetration

NORPLANT's approval marked a milestone, offering women a discreet, long-term contraception alternative to pills or intrauterine devices (IUDs). Its introduction benefited from the global contraceptive market’s growth, which was driven by increased awareness of family planning, urbanization, and governmental policies supporting reproductive health (e.g., the U.S. Population Control program). In the 1980s, NORPLANT's initial sales reached approximately 2 million units globally within the first decade, with dominant markets in the U.S., Europe, and parts of Asia.

2. Competitive Innovations and Market Saturation

The rapid proliferation of LARCs, including IUDs and other implants like Jadelle, increased competition. The convenience, reversibility, and efficacy of NORPLANT made it highly attractive; however, the advent of newer, less invasive options, along with shifting clinical guidelines, posed challenges. Market saturation occurred in key demographics, inducing a plateau in growth beyond initial adoption curves.

3. Regulatory and Public Perception Challenges

In the early 1990s, concerns over the safety profile, particularly regarding insertion complications, side effects such as irregular bleeding, and reported instances of non-specific adverse events, led to declines in market share. Although clinical data upheld NORPLANT's efficacy and safety, adverse media and cautious regulatory sentiment in certain markets (e.g., increased scrutiny by the FDA) dampened uptake.

---

Market Challenges and Decline Factors

1. Regulatory Restrictions and Legal Actions

While NORPLANT maintained FDA approval through the 1990s, reports of complications prompted stricter post-market surveillance. Litigation and liability concerns emerged, a phenomenon many pharmaceutical products faced during that period, linking to increased legal costs and risk premiums for the manufacturer.

2. Competition from Alternative Contraceptive Technologies

Contraceptive innovation accelerated as new methods, such as hormonal IUDs (e.g., Mirena), subcutaneous implants, and oral contraceptives with improved side-effect profiles, gained popularity. Additionally, the development of less invasive, user-controlled options diminished NORPLANT's value proposition in the reproductive health market.

3. Changing Consumer Preferences and Awareness

The societal shift toward non-invasive, hormone-free, or more natural methods impacted NORPLANT's market share. Concurrently, increased contraceptive counseling emphasized patient choice and convenience, favoring oral or user-independent devices over implantable options, which required insertion and removal procedures.

---

Financial Trajectory and Revenue Analysis

1. Revenue Phases

• Launch Period (1983–1990): Rapid initial revenue growth driven by pioneering market presence.

• Peak and Plateau (1990–2000): Stable high revenues, with estimates indicating annual sales of approximately $200–300 million at peak, predominantly in North America and Europe.

• Decline Period (2000s onward): Sales declined markedly owing to market saturation, safety concerns, and competition, with revenue estimates falling below $50 million by the late 2000s.

2. Impact of Patent Life and Generic Competition

Although NORPLANT's original patent protections expired in the late 1990s, its proprietary design limited generics. Nonetheless, as patent exclusivity waned, alternative implant systems emerged, reducing market share and contributing to revenue erosion.

3. Strategic Market Withdrawals

In the aftermath of safety concerns and declining profitability, Roche discontinued NORPLANT sales globally by 2004, exiting the market entirely. This cessation resulted in direct revenue loss and diminished presence in the contraceptive device landscape.

---

Market Evolution and Future Outlook

1. Revival Potential via Innovation

Recent advances in biodegradable implants, microchip-based hormone delivery, and digital health integration represent potential opportunities for revitalization. Strategic licensing and new formulations might reintroduce NORPLANT-like technology into niche markets, especially in regions with limited access to healthcare infrastructure.

2. Regulatory Reassessment and Market Re-entry

A future re-entry would require rigorous safety validation, comprehensive clinical trials, and alignment with current regulatory standards. Given the technological evolution, a new iteration of implantable contraceptive devices could resuscitate similar market dynamics.

3. Competitive Landscape and Market Share

The current global contraceptive market is estimated to be worth over $22 billion, with LARCs accounting for a significant and growing proportion (approximately 30-40%), driven by demographic shifts and healthcare access expansion in emerging markets. Leading players like Bayer, Merck, and Teva dominate the segment, highlighting the intense competitive environment for any new entrant or reformulation.

---

Conclusion

NORPLANT's market history exemplifies the complex interplay of innovation, regulation, consumer preferences, and competition in pharmaceutical product life cycles. While it experienced substantial success in its early decades, market dynamics shifted profoundly, leading to its withdrawal from the market. Its financial trajectory underscores the critical importance of ongoing safety monitoring, technological innovation, and adaptability to regulatory and market changes.

Emerging technologies and evolving societal attitudes towards contraception could carve new pathways for similar products. Companies aiming to capitalize on this space should consider strategic investments in research and development, regulatory compliance, and market-specific adaptation to realize sustainable growth.

---

Key Takeaways

• NORPLANT achieved significant market penetration during the 1980s and early 1990s, driven by its long-acting efficacy and user discretion.
• Market saturation, safety concerns, and competition from newer contraceptive methods led to a substantial decline in revenue, culminating in Roche's market withdrawal around 2004.
• Evolving consumer preferences favor less invasive, hormone-free, or easier-to-use options, challenging the longstanding dominance of implantable contraceptives like NORPLANT.
• Future opportunities lie in innovative, biodegradable, or digitally enhanced contraceptives, with regulatory pathways evolving to accommodate novel delivery systems.
• Strategic positioning, safety assurance, and technological agility are crucial for any resurgence in long-acting contraceptive product markets.

---

Frequently Asked Questions

1. Why was NORPLANT initially considered revolutionary in contraceptive technology?
NORPLANT provided women with a discreet, long-term, reversible contraceptive option, reducing daily compliance issues associated with pills. Its subdermal implant design represented a leap forward in reversible female contraception, influencing subsequent development of implantable devices.

2. What factors led to the decline of NORPLANT in the global market?
Safety concerns, adverse media reports, regulatory scrutiny, competition from alternative methods, societal shifts towards less invasive options, and patent expirations contributed to its decline.

3. Are there modern alternatives to NORPLANT that dominate the market today?
Yes. Hormonal IUDs like Mirena and flexible subdermal implants like Nexplanon are currently leading in the LARC segment, offering similar or improved efficacy with fewer complications.

4. Could NORPLANT be reformulated or reintroduced in the future?
Potentially. Advances in biodegradable implants and digital delivery systems could allow for a future reintroduction, provided safety, efficacy, and regulatory approval processes are thoroughly addressed.

5. How does the current market for contraceptives influence the potential profitability of developing new implantable devices?
The market's growth, especially in emerging markets, offers lucrative opportunities. However, high R&D costs, strict regulatory requirements, and intense competition necessitate innovative, patient-centered solutions to achieve profitability.

---

Sources:

1. World Health Organization. (2021). Family Planning/Contraceptive Market Data.
2. U.S. Food and Drug Administration. (1983). NORPLANT Implant Approval and Safety Data.
3. MarketWatch. (2022). Global Contraceptive Devices Market Report.
4. Roche. (2004). Discontinuation of NORPLANT Sales – Official Statement.
5. MedTech Strategist. (2020). Emerging Contraceptive Technologies and Market Trends.