CYCLESSA Drug Patent Profile

Which patents cover Cyclessa, and what generic alternatives are available?

Cyclessa is a drug marketed by Aspen Global Inc and is included in one NDA.

The generic ingredient in CYCLESSA is desogestrel; ethinyl estradiol. There are eight drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the desogestrel; ethinyl estradiol profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Cyclessa

A generic version of CYCLESSA was approved as desogestrel; ethinyl estradiol by DURAMED PHARMS BARR on August 12^th, 1999.

Summary for CYCLESSA

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	3
DailyMed Link:	CYCLESSA at DailyMed

US Patents and Regulatory Information for CYCLESSA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aspen Global Inc	CYCLESSA	desogestrel; ethinyl estradiol	TABLET;ORAL-28	021090-001	Dec 20, 2000	AB	RX	Yes	Yes

Expired US Patents for CYCLESSA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Aspen Global Inc	CYCLESSA	desogestrel; ethinyl estradiol	TABLET;ORAL-28	021090-001	Dec 20, 2000	4,544,554
Aspen Global Inc	CYCLESSA	desogestrel; ethinyl estradiol	TABLET;ORAL-28	021090-001	Dec 20, 2000	4,628,051
Aspen Global Inc	CYCLESSA	desogestrel; ethinyl estradiol	TABLET;ORAL-28	021090-001	Dec 20, 2000	4,616,006

International Patents for CYCLESSA

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

Country	Patent Number	Title	Estimated Expiration
Canada	1226221	ANTI-PROGRESTATIF TRIPHASE POUR ADMINISTRATION PAR VOIE ORALE (TRIPHASIC ORAL CONTRACEPTIVE)

CYCLESSA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Contraceptive Drugs: A Case Study on the Contraceptive Market

Introduction

The contraceptive drugs market is a dynamic and growing sector, driven by increasing demand for family planning solutions globally. This article will delve into the market dynamics, financial trajectory, and key factors influencing the contraceptive drugs market, using the broader context to infer insights relevant to specific drugs like those in the contraceptive category.

Global Contraceptive Drugs Market Overview

The global contraceptive drugs market was valued at USD 29,996.6 million in 2022 and is projected to grow to USD 52,871.12 million by 2031, at a CAGR of 6.50% during the forecast period (2024-2031)[1].

Market Segmentation

The market is segmented into several categories:

• By Product: Oral contraceptive pills, injectable contraceptives, and topical contraceptives. Oral contraceptive pills dominate the market due to their ease of use, affordability, and high awareness among users[1].
• By Distribution Channel: Retail pharmacy, hospital pharmacy, clinics, online channels, and public channels & NGOs. The online distribution channel is expected to grow at the fastest CAGR due to increased use of over-the-counter solutions and online discounts[1].
• By Region: North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. North America dominated the market in 2022, while the Asia Pacific region is the fastest-growing segment[1].

Market Drivers

Several factors drive the growth of the contraceptive drugs market:

• Increasing Demand for Family Planning: Over 1.1 billion women of reproductive age globally require family planning, with approximately 842 million using contraceptive methods and 270 million having unfulfilled contraceptive demand[1].
• Rising Awareness and Affordability: High patient awareness levels, especially in North America, and the launch of generic and low-cost drugs contribute to market growth[1].
• Government and Reimbursement Policies: Rising reimbursement policies in regions like the Asia Pacific are driving market expansion[1].

Market Challenges

Despite the growth, the market faces several challenges:

• Side Effects: Concerns about the side effects of contraceptive drugs can hamper market growth[1].
• Regulatory and Pricing Issues: High prices of pharmaceuticals, influenced by factors such as patent legislation and government policies, can affect market dynamics[4].

Financial Ecosystem of Pharmaceutical R&D

The development and launch of any pharmaceutical drug, including contraceptive drugs, involve significant financial investments:

• Development Costs: The average cost for developing a single approved drug is between $2.4 billion and $3.2 billion, including costs for drugs that fail to reach the market[3].
• Investment and Funding: Private investment, particularly from venture capital, is crucial for overcoming the 'translation gap' and bringing a drug to launch. Big biopharma companies play a key role in financing late-stage clinical development[3].

Expected Financial Return and Market Dynamics

The expected financial return of a drug is driven by its revenue potential, which is influenced by several factors:

• Commercial Potential: Detailed assumptions about addressable patient populations, levels of unmet need, drug-value propositions, expected uptake, and pricing potential[3].
• Global Willingness to Pay: Governments and private insurance companies' willingness to pay for new drugs significantly influences the supply and distribution of novel drugs[3].

Case Study: Contraceptive Drugs Market Dynamics

Oral Contraceptive Pills

Oral contraceptive pills are the largest revenue segment in the contraceptive drugs market. The introduction of new oral contraceptive pills and their subsequent approval have significantly impacted market expansion. Factors such as ease of use, affordability, and high awareness among users support the growth of this segment[1].

Online Distribution Channel

The online distribution channel is projected to grow at the fastest CAGR. Increased use of over-the-counter solutions, along with numerous online discounts and offers, has led to the massive growth of this channel[1].

Regional Growth

North America dominated the global market in 2022, driven by high incidence of abortion, rising population of women within the reproductive age group, and high patient awareness levels. The Asia Pacific region, particularly China and India, is the fastest-growing segment due to rising reimbursement policies and a growing maternity population[1].

Regulatory and Pricing Considerations

Regulatory frameworks and pricing policies significantly impact the market:

• Patent Legislation and Market Dynamics: Changes in patent legislation and market interventions can lead to price increases even for off-patent drugs. Governments have introduced measures like reference pricing and outcome-based pricing to control drug prices, but these often have unintended consequences[4].
• Public Debate and Policy Measures: High prices of drugs have sparked public debate and led to congressional hearings. Policy measures such as incentivizing the prescription of low-cost drugs are being explored to address these issues[4].

Financial Trajectory for Contraceptive Drugs

The financial trajectory for contraceptive drugs is influenced by the overall market growth and the specific segments within it:

• Revenue Growth: The market is expected to grow significantly, driven by increasing demand and favorable regulatory environments in some regions[1].
• Investment and Funding: Companies involved in the development of contraceptive drugs need to secure significant funding, often through a combination of private investment and public funding sources[3].

Key Takeaways

• The global contraceptive drugs market is growing rapidly, driven by increasing demand for family planning solutions.
• Oral contraceptive pills dominate the market, with the online distribution channel showing the fastest growth.
• Regulatory and pricing issues are critical factors influencing market dynamics.
• Significant financial investments are required for the development and launch of contraceptive drugs.
• The expected financial return of a drug is driven by its revenue potential, influenced by commercial potential and global willingness to pay.

FAQs

What is the projected growth rate of the global contraceptive drugs market?

The global contraceptive drugs market is projected to grow at a CAGR of 6.50% from 2024 to 2031[1].

Which segment dominates the contraceptive drugs market?

The oral contraceptive pills segment accounts for the largest revenue share in the market[1].

What are the key drivers of the contraceptive drugs market?

Key drivers include increasing demand for family planning, rising awareness and affordability, and favorable government and reimbursement policies[1].

How do regulatory and pricing issues impact the market?

Regulatory frameworks and pricing policies can lead to price increases and affect market dynamics. Governments are introducing measures to control drug prices, but these often have unintended consequences[4].

What is the role of private investment in the development of contraceptive drugs?

Private investment, particularly from venture capital, is crucial for overcoming the 'translation gap' and bringing a drug to launch. Big biopharma companies play a key role in financing late-stage clinical development[3].

Sources

1. SkyQuest: Contraceptive Drugs Market Size & Share | Industry Growth [2030][1]
2. Cyclerion: Cyclerion Announces Corporate Updates and Q1 2023 Financial[2]
3. RAND: The Financial Ecosystem of Pharmaceutical R&D[3]
4. PLOS ONE: Addressing the challenge of high-priced prescription drugs in the era of precision medicine: A systematic review of drug life cycles, therapeutic drug markets and regulatory frameworks[4]