You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 22, 2024

LUNELLE Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


AI Research Assistant
Questions you can ask:
  • What is the 5 year forecast for LUNELLE?
  • What are the global sales for LUNELLE?
  • What is Average Wholesale Price for LUNELLE?
Summary for LUNELLE
Drug patent expirations by year for LUNELLE
Recent Clinical Trials for LUNELLE

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

SponsorPhase
Sun Pharmaceutical Industries LimitedPhase 1/Phase 2

See all LUNELLE clinical trials

US Patents and Regulatory Information for LUNELLE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pharmacia And Upjohn LUNELLE estradiol cypionate; medroxyprogesterone acetate INJECTABLE;INTRAMUSCULAR 020874-001 Oct 5, 2000 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

LUNELLE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Lunelle

Introduction

Lunelle, an injectable estrogen/progestin contraceptive, was introduced to the market with promising potential but faced significant challenges that ultimately led to its withdrawal. Here, we delve into the market dynamics and financial trajectory of Lunelle to understand its rise and fall.

Product Overview

Lunelle was the first monthly injectable contraceptive available in the United States. It was administered on a monthly basis and was known for its safety and contraceptive efficacy, as established through international and US clinical trials[4].

Market Entry and Initial Reception

Lunelle was marketed in the USA between 2000 and 2002. During its initial phase, it showed high patient satisfaction and was considered a potential first-line contraceptive option. The product's monthly administration schedule was seen as a convenient alternative to other contraceptive methods[4].

Clinical Efficacy and Safety

Clinical trials confirmed Lunelle's safety and efficacy. The product was well-received by patients, with studies noting a high level of satisfaction. Additionally, fertility returned rapidly after discontinuation of the injections, which was a significant advantage[4].

Production Issues and Market Withdrawal

Despite its clinical success, Lunelle faced significant production issues. These problems led to the drug's withdrawal from the US market in 2002. The manufacturer, Pharmacia, was forced to recall the drug due to these production challenges[2][5].

Financial Impact

The financial trajectory of Lunelle was heavily impacted by its short market lifespan and production issues. The investment in developing and marketing Lunelle did not yield long-term returns due to its early withdrawal. This situation highlights the risks associated with pharmaceutical product development, where significant investments can be lost if a product fails to maintain market presence[3].

Market Dynamics

The contraceptive market is highly competitive and subject to stringent regulatory standards. For Lunelle, the inability to resolve production issues quickly enough led to a loss of market share and eventual withdrawal. This case underscores the importance of robust manufacturing processes and quality control in pharmaceuticals[3].

Consumer and Market Response

The initial positive response from consumers and healthcare providers was promising, but the production issues overshadowed these gains. The lack of availability and reliability of the product led to a decline in consumer trust and a shift towards other contraceptive options[4].

Comparison with Other Injectable Contraceptives

In contrast to Lunelle, other injectable contraceptives like Depo-Provera (depot medroxyprogesterone acetate) have maintained a strong market presence despite some controversies. These products have longer administration intervals (typically every three months) and have been more successful in terms of market sustainability[2].

Lessons Learned

The story of Lunelle serves as a cautionary tale for pharmaceutical companies. It highlights the critical importance of ensuring robust production processes and maintaining high-quality standards to avoid market withdrawal. Additionally, it emphasizes the need for continuous monitoring and improvement of manufacturing practices to sustain market presence[3].

Impact on Future Developments

The experience with Lunelle has influenced the development of subsequent contraceptive products. For instance, the focus on self-injection technologies, such as the Sayana Press, has been driven in part by the need to improve accessibility and reliability of injectable contraceptives. These innovations aim to address the gaps left by products like Lunelle[2].

Key Takeaways

  • Product Efficacy: Lunelle was clinically proven to be safe and effective.
  • Production Issues: The drug was withdrawn due to production problems.
  • Market Impact: The withdrawal led to a significant financial loss and a decline in consumer trust.
  • Market Dynamics: The competitive nature of the contraceptive market and the importance of robust manufacturing processes.
  • Lessons Learned: Ensuring high-quality production is crucial for market sustainability.

FAQs

Q: What was Lunelle, and how was it administered? A: Lunelle was a monthly injectable estrogen/progestin contraceptive administered on a monthly basis.

Q: Why was Lunelle withdrawn from the market? A: Lunelle was withdrawn due to production issues that the manufacturer, Pharmacia, could not resolve.

Q: How did the withdrawal of Lunelle impact the contraceptive market? A: The withdrawal led to a shift towards other contraceptive options and highlighted the importance of reliable production processes in pharmaceuticals.

Q: What were the clinical outcomes of Lunelle? A: Clinical trials established Lunelle's safety and contraceptive efficacy, with high patient satisfaction and rapid return of fertility after discontinuation.

Q: What lessons can be learned from the Lunelle experience? A: The importance of robust production processes and high-quality standards to avoid market withdrawal and maintain consumer trust.

Sources

  1. Stellar Market Research - Injectable Contraceptives Market - Industry Analysis and Forecast
  2. Population Research Institute - USAID Needs to Warn Women of the Dangers of Depo-Provera
  3. National Bureau of Economic Research - The Economics of Drug Development: Pricing and Innovation in a Changing Market
  4. PubMed - Lunelle monthly injectable contraceptive. An effective, safe, and convenient option.
  5. Sage Journals - Addressing Gaps in the Contraceptive Method Mix

More… ↓

⤷  Subscribe

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.