SEASONIQUE Drug Patent Profile

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

Seasonique 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 SEASONIQUE 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 Seasonique

Annual sales in 2021 were $6mm indicating the motivation for generic entry (peak sales were $109mm in 2011).

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 SEASONIQUE

International Patents:	22
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	5
Clinical Trials:	5
Drug Prices:	Drug price information for SEASONIQUE
Drug Sales Revenues:	Drug sales revenues for SEASONIQUE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SEASONIQUE
What excipients (inactive ingredients) are in SEASONIQUE?	SEASONIQUE excipients list
DailyMed Link:	SEASONIQUE at DailyMed

See drug prices for SEASONIQUE

See drug sales revenues for SEASONIQUE

Recent Clinical Trials for SEASONIQUE

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

Sponsor	Phase
Duramed Research	Phase 3
Duramed Research	Phase 2

See all SEASONIQUE clinical trials

Paragraph IV (Patent) Challenges for SEASONIQUE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SEASONIQUE	Tablets	ethinyl estradiol; levonorgestrel	0.15 mg/0.03 mg/0.01 mg	021840	1	2008-01-22

US Patents and Regulatory Information for SEASONIQUE

SEASONIQUE 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	SEASONIQUE	ethinyl estradiol; levonorgestrel	TABLET;ORAL	021840-001	May 25, 2006	AB	RX	Yes	Yes	7,855,190

Expired US Patents for SEASONIQUE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva Branded Pharm	SEASONIQUE	ethinyl estradiol; levonorgestrel	TABLET;ORAL	021840-001	May 25, 2006	7,858,605
Teva Branded Pharm	SEASONIQUE	ethinyl estradiol; levonorgestrel	TABLET;ORAL	021840-001	May 25, 2006	7,320,969
Teva Branded Pharm	SEASONIQUE	ethinyl estradiol; levonorgestrel	TABLET;ORAL	021840-001	May 25, 2006	7,615,545

International Patents for SEASONIQUE

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

Country	Patent Number	Title	Estimated Expiration
South Africa	200404249	ORAL CONTRACEPTIVES TO PREVENT PREGNANCY AND DIMINISH PREMENSTRUAL SYMPTOMATOLOGY
New Zealand	585546	Methods of hormonal treatment utilizing contraceptive regimens with continuous estrogen administration
Israel	162182	KITS CONTAINING ORAL CONTRACEPTIVES AND METHODS UTILIZING THE SAME
Hong Kong	1154485
Russian Federation	2010118424	СПОСОБЫ ГОРМОНАЛЬНОГО ЛЕЧЕНИЕ С ПРИМЕНЕНИЕМ КОНТРАЦЕПТИВНЫХ РЕЖИМОВ С НЕПРЕРЫВНЫМ ВВЕДЕНИЕМ ЭСТРОГЕНА
China	100581550
Brazil	PI0214716	kit, preparos, e uso de estrogênio e progestina na fabricação de um medicamento para uso na prevenção de gravidez

Supplementary Protection Certificates for SEASONIQUE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1214076	SZ 49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON
0771217	07C0001	France		PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
1214076	49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612
0398460	C300221	Netherlands		PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
1453521	132016000025143	Italy		PRODUCT NAME: LEVONORGESTREL ED ETINILESTRADIOLO(SEASONIQUE); AUTHORISATION NUMBER(S) AND DATE(S): 17/0017/15-S, 20150211;042139016, 20150414
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

Market Dynamics and Financial Trajectory for Seasonique

Introduction

Seasonique, an extended-cycle oral contraceptive, has been a significant player in the women's health market since its approval. This article delves into the market dynamics and financial trajectory of Seasonique, highlighting its impact, challenges, and financial performance.

Product Overview

Seasonique is a 91-day extended regimen oral contraceptive consisting of a fixed dose combination of levonorgestrel 150 µg and ethinylestradiol 30 µg for 84 days, followed by ethinylestradiol 10 µg for 7 days. This regimen reduces the number of withdrawal bleeding episodes to four per year, compared to 13 episodes with conventional 28-day regimens[3][4].

Market Positioning

Seasonique extends the contraceptive options available to women, particularly those who desire fewer withdrawal bleeding episodes. It has been approved for the prevention of pregnancy in adult women and has shown efficacy in large clinical trials[3].

Target Market

The primary target market for Seasonique includes women of reproductive age who prefer fewer menstrual cycles. This product is especially appealing to women who have previously used oral contraceptives and are looking for an alternative with reduced bleeding episodes[4].

Clinical Efficacy and Safety

Contraceptive Efficacy

Seasonique has demonstrated effective contraception in clinical trials. The overall Pearl index (pregnancies per 100 woman-years of use) in women aged 18-35 years was 0.76, and the method-failure Pearl index was 0.26[3].

Bleeding Pattern

While Seasonique reduces scheduled bleeding episodes, it is associated with increased unscheduled bleeding and spotting, particularly in the initial cycles. However, this does not significantly impact compliance or safety[1][3].

Safety Profile

Seasonique is generally well-tolerated, with a safety profile consistent with other combined oral contraceptives (COCs). It is contraindicated in women over 35 years old who smoke due to increased risk of serious cardiovascular events[4].

Regulatory Challenges

Approval Process

The approval process for Seasonique was not without challenges. During the decentralised procedure, Germany raised concerns about the contraceptive efficacy of Seasonique, which led to a referral to the Committee for Medicinal Products for Human Use (CHMP). Despite these concerns, the CHMP ultimately considered the efficacy of Seasonique adequately demonstrated[1].

Financial Performance

Sales and Revenue

Seasonique has contributed significantly to the revenue of its manufacturers. In the third quarter of 2008, Barr Pharmaceuticals, the original manufacturer, reported increased sales of proprietary products, including Seasonique. The sales of Seasonique, along with other oral contraceptives, were a key factor in the company's revenue growth, with generic oral contraceptive sales increasing to $159 million from $112 million in the prior year period[2].

Market Impact

The launch of Seasonique and similar extended-cycle oral contraceptives has impacted the market by offering women more choices and driving sales in the women's health segment. The product's unique regimen has attracted a significant market share, contributing to the overall growth of the oral contraceptive market[2].

Competitive Landscape

Generic Competition

The oral contraceptive market is highly competitive, with both branded and generic products available. Seasonique faces competition from other extended-cycle oral contraceptives as well as conventional 28-day regimens. However, its unique dosing regimen and reduced bleeding episodes have helped it maintain a distinct market position[2].

Market Expansion

The sales of Seasonique have been strong not only in North America but also in European and Rest of the World (ROW) markets. The product's success has been supported by favorable market conditions, including higher sales in various ROW markets and positive impacts from foreign currency fluctuations[2].

Financial Outlook and Projections

Historical Performance

In 2008, Barr Pharmaceuticals reported strong financial performance, with total revenues of $2.1 billion for the first nine months, up from $1.8 billion in the prior year. The company's adjusted earnings per share were $2.05 for the same period, reflecting the positive impact of Seasonique and other proprietary products on the company's financials[2].

Future Projections

While specific future projections for Seasonique are not available, the overall trend in the women's health market suggests continued demand for innovative contraceptive options. As the market evolves, products like Seasonique are likely to remain competitive, driven by their unique benefits and strong clinical profiles.

Key Takeaways

• Unique Regimen: Seasonique offers a 91-day extended regimen, reducing withdrawal bleeding episodes to four per year.
• Clinical Efficacy: The product has demonstrated effective contraception with a low Pearl index.
• Safety Profile: Generally well-tolerated, but with increased unscheduled bleeding and spotting.
• Regulatory Challenges: Faced concerns over efficacy during the approval process but was ultimately approved.
• Financial Performance: Contributed significantly to the revenue of its manufacturers, particularly in the women's health segment.
• Competitive Landscape: Faces competition from other oral contraceptives but maintains a distinct market position.

FAQs

Q: What is the unique dosing regimen of Seasonique?

A: Seasonique consists of levonorgestrel 150 µg and ethinylestradiol 30 µg for 84 days, followed by ethinylestradiol 10 µg for 7 days, reducing withdrawal bleeding episodes to four per year.

Q: How effective is Seasonique as a contraceptive?

A: Seasonique has a low Pearl index, with an overall Pearl index of 0.76 and a method-failure Pearl index of 0.26 in women aged 18-35 years.

Q: What are the common side effects of Seasonique?

A: Common side effects include increased unscheduled bleeding and spotting, particularly in the initial cycles.

Q: Is Seasonique contraindicated in any specific group of women?

A: Yes, it is contraindicated in women over 35 years old who smoke due to increased risk of serious cardiovascular events.

Q: How has Seasonique impacted the financial performance of its manufacturers?

A: Seasonique has contributed significantly to the revenue of its manufacturers, driving growth in the women's health segment and overall company revenues.

Sources

1. European Medicines Agency. Seasonique Art 29(4) - European Medicines Agency.
2. Biospace. Barr Pharmaceuticals, Inc. Reports Third Quarter 2008 GAAP Earnings of $0.28 Per Share, Adjusted Earnings of $0.83 Per Share.
3. PubMed. A Review of Its Use as an Oral Contraceptive.
4. Drugs.com. Seasonique: Package Insert / Prescribing Information.