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-three 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:	104
Clinical Trials:	7
Patent Applications:	4,728
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
Oregon Health and Science University	Phase 4
Society of Family Planning	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	3,850,911
Population Council	NORPLANT	levonorgestrel	IMPLANT;IMPLANTATION	019897-001	Dec 10, 1990	3,959,322

International Patents for NORPLANT

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

Country	Patent Number	Title	Estimated Expiration
Belgium	645391
Philippines	9894	13-ALKYL-GONA-1,3,5(10),9(11)-TETRAENES AND PROCESS OF THEIR MANUFACTURE
Germany	1468643	Verfahren zur Herstellung von 2-(1'-Tetralyliden-aethyl)-2-alkyl-cyclopentan-1,3-dionen

Supplementary Protection Certificates for NORPLANT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1453521	132016000025143	Italy		PRODUCT NAME: LEVONORGESTREL ED ETINILESTRADIOLO(SEASONIQUE); AUTHORISATION NUMBER(S) AND DATE(S): 17/0017/15-S, 20150211;042139016, 20150414
1453521	93156	Luxembourg		PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 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

NORPLANT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Norplant

Introduction

Norplant, a revolutionary contraceptive device approved by the FDA in 1990, was hailed as a significant advance in reproductive technology. However, its market dynamics and financial trajectory were marked by several challenges and controversies.

Development and Approval

Norplant was developed in the 1960s and gained FDA approval in December 1990. It consisted of six matchstick-size silicone capsules inserted under the skin of the upper arm, releasing the progestin levonorgestrel over five years[4].

Market Entry and Distribution

Wyeth-Ayerst, the American distributor of Norplant, was a major player in the contraceptive market, already selling several birth control pill formulations. The company anticipated that Norplant would capture an additional 1-2% of the private sector and 3-5% of the public sector in total contraceptive sales[1].

Pricing and Accessibility

One of the significant hurdles for Norplant was its high cost. Each Norplant kit cost around $350, plus an additional $100 for the insertion procedure. This made it unaffordable for many clinics, especially those relying on Medicaid funding. The cost was so prohibitive that a clinic director in Missouri noted that providing Norplant to 100 women would consume the entire annual budget of a small clinic, which could otherwise provide oral contraceptives to 1,500 women[1].

Competitive Landscape

Norplant faced stiff competition from other contraceptive methods, such as oral contraceptives and IUDs, which were offered to clinics at below-market costs. This made Norplant less competitive in terms of pricing, further limiting its adoption[1].

Side Effects and User Satisfaction

Despite its effectiveness, Norplant was associated with several side effects, including irregular and prolonged menstrual bleeding, headaches, weight changes, and acne. While most women were satisfied with Norplant and would recommend it, these side effects were a significant consideration for potential users[3][4].

Impact on Reproductive Freedom

Norplant's introduction was also marred by concerns over reproductive freedom. It was often used as a condition of probation for women who used drugs during pregnancy, disproportionately affecting low-income women and women of color. This raised ethical and legal issues, reminiscent of the eugenics movement, and highlighted the potential for abuse of the contraceptive[3][4].

Legislative and Public Response

The use of Norplant as a condition for public assistance or probation sparked intense debate. Congressional hearings were held to discuss the accessibility and ethical implications of Norplant. The General Accounting Office (GAO) report in 1994 noted that the demand for Norplant had leveled off and in some cases declined, partly due to its high cost and the availability of alternative long-term contraceptives like Depo-Provera[1].

Financial Performance

Wyeth-Ayerst did not anticipate Norplant to be a blockbuster product but hoped it would broaden their presence in the contraceptive market. However, the high cost and limited accessibility of Norplant meant it did not achieve the predicted market share. The financial returns were disappointing, especially when compared to other contraceptive methods that were more affordable and widely adopted[1].

Market Decline

By the mid-1990s, the demand for Norplant had significantly declined. The GAO report and other studies indicated that the high cost, limited availability, and side effects contributed to this decline. Additionally, the introduction of other long-term contraceptives like Depo-Provera further reduced the market share of Norplant[1].

Industry Dynamics

The pharmaceutical industry's dynamics during this period were characterized by a shift towards cost-efficiency and market share retention. Companies were adapting to shrinking profit margins by focusing on specialty areas, vertical expansion, and total disease management. However, Norplant's failure to gain significant market share highlighted the challenges of introducing a new, expensive product into a competitive market[5].

Conclusion

Norplant's market dynamics and financial trajectory were marked by high expectations followed by significant challenges. Despite its effectiveness, the contraceptive faced hurdles related to cost, accessibility, and ethical concerns. The decline in demand and the introduction of alternative contraceptives further diminished its market presence.

Key Takeaways

• Norplant was approved by the FDA in 1990 but faced significant market challenges.
• High costs and limited accessibility were major barriers to its adoption.
• The contraceptive was associated with several side effects, affecting user satisfaction.
• Ethical concerns and legislative debates surrounded its use, particularly as a condition for public assistance or probation.
• The demand for Norplant declined due to these factors and the introduction of alternative contraceptives.

FAQs

Q: What is Norplant and how does it work? A: Norplant is a contraceptive device consisting of six silicone capsules inserted under the skin of the upper arm, releasing the progestin levonorgestrel over five years[4].

Q: Why was Norplant's market performance disappointing? A: Norplant's high cost, limited accessibility, and side effects contributed to its disappointing market performance. Additionally, the availability of alternative long-term contraceptives reduced its market share[1].

Q: How did Norplant impact reproductive freedom? A: Norplant's use as a condition for public assistance or probation raised concerns over reproductive freedom, particularly affecting low-income women and women of color[3][4].

Q: What were the common side effects of Norplant? A: Common side effects included irregular and prolonged menstrual bleeding, headaches, weight changes, and acne[3][4].

Q: How did the pharmaceutical industry respond to Norplant's market challenges? A: The industry focused on cost-efficiency, market share retention, and adapting to changing market dynamics, but Norplant's specific challenges were not adequately addressed[5].

Cited Sources

1. From Breakthrough to Bust The Brief Life of Norplant - Journal of Women’s History
2. The National Cancer Program - National Cancer Institute
3. Norplant and the Control of African-American Motherhood - UCLA Women's Law Journal
4. Norplant: A New Contraceptive with the Potential for Abuse - ACLU
5. The Translators: Sectoral Roles in Contraceptive Research - NCBI