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LOSEASONIQUE Drug Patent Profile

When do Loseasonique patents expire, and when can generic versions of Loseasonique launch?

Loseasonique is a drug marketed by Teva Branded Pharm and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has twenty-two patent family members in ten countries.

The generic ingredient in LOSEASONIQUE is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.

DrugPatentWatch^® Generic Entry Outlook for Loseasonique

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

There are two tentative approvals for the generic drug (ethinyl estradiol; levonorgestrel), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for LOSEASONIQUE

International Patents:	22
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	5
Drug Prices:	Drug price information for LOSEASONIQUE
What excipients (inactive ingredients) are in LOSEASONIQUE?	LOSEASONIQUE excipients list
DailyMed Link:	LOSEASONIQUE at DailyMed

See drug prices for LOSEASONIQUE

Paragraph IV (Patent) Challenges for LOSEASONIQUE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LOSEASONIQUE	Tablets	ethinyl estradiol; levonorgestrel	0.1 mg/0.02 mg and 0.01 mg	022262	1	2009-11-16

US Patents and Regulatory Information for LOSEASONIQUE

LOSEASONIQUE is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Branded Pharm	LOSEASONIQUE	ethinyl estradiol; levonorgestrel	TABLET;ORAL	022262-001	Oct 24, 2008	AB	RX	No	No

Expired US Patents for LOSEASONIQUE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva Branded Pharm	LOSEASONIQUE	ethinyl estradiol; levonorgestrel	TABLET;ORAL	022262-001	Oct 24, 2008
Teva Branded Pharm	LOSEASONIQUE	ethinyl estradiol; levonorgestrel	TABLET;ORAL	022262-001	Oct 24, 2008

International Patents for LOSEASONIQUE

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

Country	Patent Number	Title	Estimated Expiration
New Zealand	545130	Methods of hormonal treatment utilizing contraceptive regimens with continuous estrogen administration
Canada	2468748	CONTRACEPTIFS ORAUX POUR EVITER LES GROSSESSES ET DIMINUER LA SYMPTOMATOLOGIE PREMENSTRUELLE (ORAL CONTRACEPTIVES TO PREVENT PREGNANCY AND DIMINISH PREMENSTRUAL SYMPTOMATOLOGY)
New Zealand	574964	Methods of hormonal treatment utilizing contraceptive regimens with continuous estrogen administration
Japan	2006525358
Spain	2561491

Supplementary Protection Certificates for LOSEASONIQUE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1453521	93156	Luxembourg		PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
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
1380301	CA 2009 00017	Denmark		PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
1214076	C01214076/01	Switzerland		PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
1453521	122015000093	Germany		PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129

LOSEASONIQUE Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for LOSEASONIQUE

Introduction

LOSEASONIQUE, a combination oral contraceptive containing levonorgestrel and ethinyl estradiol, is a significant player in the contraceptive market. Understanding its market dynamics and financial trajectory is crucial for investors, healthcare providers, and patients.

Market Overview

The contraceptive market is highly competitive and dynamic, driven by factors such as demographic changes, regulatory environments, and technological advancements. LOSEASONIQUE, approved in 1982, has established itself as a reliable option for women seeking effective contraception.

Market Size and Growth

The global contraceptive market is projected to grow significantly due to increasing awareness about family planning and reproductive health. LOSEASONIQUE, being a well-established brand, benefits from this growth trend. However, the market is also subject to fluctuations based on economic conditions, healthcare policies, and the introduction of new contraceptive methods[3].

Target Market

LOSEASONIQUE is indicated for use by females of reproductive potential to prevent pregnancy. The target market includes women of childbearing age who are seeking a reliable and convenient contraceptive method.

Demographic Analysis

The primary demographic for LOSEASONIQUE includes women aged 18-45 who are sexually active and wish to prevent pregnancy. This demographic is further segmented based on factors such as age, health status, and lifestyle preferences.

Competitive Landscape

The contraceptive market is highly competitive, with various forms of contraception available, including oral contraceptives, patches, rings, and intrauterine devices (IUDs). LOSEASONIQUE competes with other combination oral contraceptives as well as newer forms of contraception like the Twirla patch[3].

Key Competitors

• Other combination oral contraceptives
• Contraceptive patches (e.g., Twirla)
• Contraceptive rings
• Intrauterine devices (IUDs)

Financial Performance

The financial performance of LOSEASONIQUE is influenced by several factors, including sales volume, pricing strategies, and market competition.

Revenue Streams

The revenue generated from LOSEASONIQUE comes primarily from prescription sales. The drug is widely prescribed and covered by many health insurance plans, contributing to its steady revenue stream.

Cost Structure

The cost structure includes manufacturing costs, research and development expenses, marketing and sales expenditures, and regulatory compliance costs. Given the established nature of LOSEASONIQUE, the research and development costs are relatively lower compared to newer products.

Regulatory Environment

The regulatory environment plays a critical role in the financial trajectory of LOSEASONIQUE.

FDA Approval and Compliance

LOSEASONIQUE has been approved by the FDA since 1982, and it must comply with ongoing regulatory requirements. Any changes in FDA guidelines or safety warnings can impact its market position and financial performance[1][4].

Safety and Efficacy

The drug is subject to continuous monitoring for safety and efficacy. Adverse events such as thrombotic or thromboembolic events, liver disease, and hypertension require careful management and may affect its market reputation and sales[1][4].

Marketing and Sales Strategies

Effective marketing and sales strategies are essential for maintaining and growing the market share of LOSEASONIQUE.

Distribution Channels

LOSEASONIQUE is distributed through various channels, including pharmacies, healthcare providers, and online platforms. Strong relationships with these channels are crucial for ensuring widespread availability.

Promotional Activities

Promotional activities include educational campaigns for healthcare providers, patient education programs, and advertising. These efforts help in maintaining brand awareness and driving prescriptions.

Challenges and Opportunities

Despite its established presence, LOSEASONIQUE faces several challenges and opportunities.

Challenges

• Competition from Newer Products: Newer contraceptive methods like the Twirla patch pose a competitive threat.
• Regulatory Risks: Changes in regulatory requirements or safety warnings can impact sales.
• Side Effects and Health Risks: Associated health risks such as cardiovascular events and liver disease can affect market perception[1][4].

Opportunities

• Expanding Market: Growing awareness about reproductive health in emerging markets presents opportunities for expansion.
• Brand Loyalty: Established brand reputation can lead to continued customer loyalty.
• Innovative Marketing: Leveraging digital marketing and patient education programs can enhance brand visibility and drive sales.

Financial Projections

Financial projections for LOSEASONIQUE are influenced by market trends, competitive dynamics, and regulatory factors.

Revenue Projections

Given the stable demand for oral contraceptives and the established market position of LOSEASONIQUE, revenue is expected to remain steady or grow modestly over the next few years.

Profit Margins

Profit margins are expected to be maintained or slightly increased due to efficient cost management and effective marketing strategies.

Key Takeaways

• LOSEASONIQUE operates in a competitive but growing contraceptive market.
• The drug's financial performance is influenced by sales volume, pricing, and regulatory compliance.
• Effective marketing and distribution strategies are crucial for maintaining market share.
• The drug faces challenges from newer products and regulatory risks but also has opportunities for expansion in emerging markets.

FAQs

Q: What is LOSEASONIQUE used for?

LOSEASONIQUE is used by females of reproductive potential to prevent pregnancy. It is a combination oral contraceptive containing levonorgestrel and ethinyl estradiol[1].

Q: What are the potential health risks associated with LOSEASONIQUE?

Potential health risks include increased risk of cardiovascular and cerebrovascular events, liver disease, hypertension, and adverse carbohydrate and lipid metabolic effects[1][4].

Q: How does LOSEASONIQUE compare to other contraceptive methods?

LOSEASONIQUE competes with other oral contraceptives, contraceptive patches like Twirla, rings, and IUDs. It offers a convenient and reliable method of contraception but may have different side effect profiles compared to other methods[3].

Q: What are the regulatory requirements for LOSEASONIQUE?

LOSEASONIQUE must comply with FDA regulations and ongoing safety monitoring. Any changes in FDA guidelines or safety warnings can impact its market position and financial performance[1][4].

Q: What are the financial projections for LOSEASONIQUE?

Financial projections indicate steady or modest growth in revenue due to stable demand and efficient cost management. Profit margins are expected to be maintained or slightly increased[3].

Sources

1. Drugs.com: LOSEASONIQUE: Package Insert / Prescribing Information.
2. e-ZAAIN: (Irrelevant to the topic)
3. Agile Therapeutics, Inc.: FORM S-1 AGILE THERAPEUTICS, INC.
4. EMPR: LOSEASONIQUE Prescription & Dosage Information.