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-three 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:	104
Clinical Trials:	7
Patent Applications:	3,705
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
Society of Family Planning	Phase 4
Oregon Health and Science University	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
Switzerland	427785	Verfahren zur Herstellung von Steroiden
Sweden	341183
Philippines	11432	SYNTHESIS OF 13-POLYCARBONALKYLGONA-2,5(10)-DIENE-17-OLS

Supplementary Protection Certificates for NORPLANT SYSTEM IN PLASTIC CONTAINER

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1453521	300814	Netherlands		PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: 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	122015000093	Germany		PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129

NORPLANT SYSTEM IN PLASTIC CONTAINER Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of the Norplant System

Introduction

The Norplant System, a subdermal contraceptive implant, has had a complex and evolving market presence since its introduction in the 1990s. Here, we will delve into the market dynamics and financial trajectory of this product.

Historical Context

Norplant, developed in the 1960s and approved by the FDA in 1990, was initially seen as a breakthrough in long-acting contraceptive methods. Wyeth-Ayerst, the American distributor, aimed to expand its presence in the contraceptive market with Norplant[4].

Initial Market Reception

When Norplant was first introduced, it faced significant challenges due to its high up-front costs. The implant's price, which included the cost of insertion and removal, made it difficult for many clinics, especially Title X clinics, to offer it to all clients requesting it. This high cost led to a substantial financial burden on clinics, with some clinics having to choose between providing Norplant to a few women or oral contraceptives to many more[2][4].

Financial Impact on Clinics

The financial strain on clinics was considerable. For example, providing Norplant to 100 clients could cost a clinic around $45,000 annually, which was a significant portion of the budget for a small clinic. This led to a decline in demand as clinics opted for more cost-effective contraceptive methods like oral contraceptives and IUDs[2][4].

Government and Private Sector Initiatives

To mitigate the financial burden, various initiatives were undertaken. States and private organizations provided funds to help clinics purchase Norplant. For instance, Wisconsin used privately donated funds to purchase Norplant for low-income women, and California allocated $5 million for Norplant in state fiscal years 1992-1994. The Norplant Foundation, established by Wyeth-Ayerst, also provided free kits to low-income women without medical insurance[2].

Market Growth and Decline

Despite initial enthusiasm, the demand for Norplant declined over time. Several factors contributed to this decline, including the high up-front costs, the long-term nature of the implant, and the surgical insertion and removal procedures. By the mid-1990s, the demand for Norplant had leveled off and in some cases declined, making it less of a budgetary issue for Title X clinics but also reducing its market presence[2].

Comparative Cost Analysis

When comparing the cost of Norplant to other contraceptives, it is important to consider the duration of use. While Norplant's 5-year life made its daily cost comparable to other contraceptives, most women did not use the implant for the full 5 years. Amortizing the cost over a 3-year period increased the daily cost significantly, making it less competitive with other methods[2].

Regional and Global Market

The global market for subdermal contraceptive implants, which includes Norplant, has seen growth driven by factors such as rising demand for reliable contraceptives and increasing awareness of sexual health and family planning. However, Norplant itself is no longer the dominant player in this market. The levonorgestrel implant, such as Jadelle, has become more prominent due to its efficacy and lower failure rate[1].

Current Market Landscape

The current market for subdermal contraceptive implants is dominated by the hospital segment, which accounted for 54.4% of the market share in 2023. North America, particularly the U.S. and Canada, leads in market growth due to government initiatives and the rising number of unintended pregnancies[1].

Financial Trajectory

The financial trajectory of Norplant has been marked by initial high costs and subsequent decline in demand. While the global subdermal contraceptive implants market is projected to grow at a CAGR of 7.5% from 2024 to 2030, Norplant's specific financial performance has been overshadowed by newer and more cost-effective alternatives[1].

Key Takeaways

• High Up-Front Costs: Norplant's initial high costs were a significant barrier to its adoption.
• Decline in Demand: The demand for Norplant declined due to its long-term nature and surgical procedures.
• Government Initiatives: Various government and private sector initiatives helped mitigate the financial burden but did not sustain long-term demand.
• Market Dominance: The market is now dominated by other subdermal contraceptive implants like the levonorgestrel implant.
• Global Market Growth: The global market for subdermal contraceptive implants continues to grow, driven by increasing awareness and demand for reliable contraceptives.

FAQs

Q: What were the main challenges faced by Norplant when it was first introduced? A: The main challenges included high up-front costs, long-term nature, and the need for surgical insertion and removal procedures.

Q: How did government and private sector initiatives impact the availability of Norplant? A: These initiatives provided financial support to clinics, helping them purchase Norplant for low-income women, but did not sustain long-term demand.

Q: Which segment dominates the current market for subdermal contraceptive implants? A: The hospital segment dominates the current market, accounting for 54.4% of the market share in 2023.

Q: What is the projected growth rate for the global subdermal contraceptive implants market? A: The global subdermal contraceptive implants market is projected to grow at a CAGR of 7.5% from 2024 to 2030.

Q: Why has the levonorgestrel implant become more prominent in the market? A: The levonorgestrel implant, such as Jadelle, has become more prominent due to its efficacy and lower failure rate, making it a more suitable choice for women.

Sources

1. Grand View Research - Subdermal Contraceptive Implants Market Size Report, 2030
2. GAO - CLINICS Strain of Norplant's High Up-Front Costs Has Subsided
3. Towards Healthcare - Pharmaceutical Packaging Market Size, Trends and Statistics
4. Journal of Women’s History - From Breakthrough to Bust The Brief Life of Norplant[1][2][4]