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QUARTETTE Drug Patent Profile

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

Quartette is a drug marketed by Teva Branded Pharm and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-three patent family members in thirteen countries.

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

DrugPatentWatch^® Generic Entry Outlook for Quartette

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

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 QUARTETTE

International Patents:	23
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	5
Patent Applications:	277
Drug Prices:	Drug price information for QUARTETTE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for QUARTETTE
What excipients (inactive ingredients) are in QUARTETTE?	QUARTETTE excipients list
DailyMed Link:	QUARTETTE at DailyMed

See drug prices for QUARTETTE

See drug sales revenues for QUARTETTE

Paragraph IV (Patent) Challenges for QUARTETTE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
QUARTETTE	Tablets	ethinyl estradiol; levonorgestrel	0.15 mg/0.02 mg, 0.15 mg/0.025 mg, 0.15 mg/0.03 mg and 0.01 mg	204061	1	2013-07-10

US Patents and Regulatory Information for QUARTETTE

QUARTETTE is protected by two 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	QUARTETTE	ethinyl estradiol; levonorgestrel	TABLET;ORAL	204061-001	Mar 28, 2013	AB	RX	Yes	Yes
Teva Branded Pharm	QUARTETTE	ethinyl estradiol; levonorgestrel	TABLET;ORAL	204061-001	Mar 28, 2013	AB	RX	Yes	Yes			Y

International Patents for QUARTETTE

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

Country	Patent Number	Title	Estimated Expiration
Israel	198441	שיטות למניעת הריון בנקבות בשימוש במינונים הורמוניים עולים (Methods of female contraception using ascending hormonal dosages)
European Patent Office	2392333	Procédé de traitement hormonal utilisant des régimes de cycle étendu à dose croissante (Methods of hormonal treatment utilizing ascending-dose extended cycle regimens)
Brazil	PI0516247	métodos de tratamento hormonal, utilizando regimes de ciclo prolongado de dose crescente
Russian Federation	2009120528	СПОСОБЫ ГОРМОНАЛЬНОЙ ТЕРАПИИ ВОЗРАСТАЮЩИМИ ДОЗАМИ В РЕЖИМЕ ПРОЛОНГИРОВАННОГО ЦИКЛА
European Patent Office	2392332	Procédé de traitement hormonal utilisant des régimes de cycle étendu à dose croissante (Methods of hormonal treatment utilizing ascending-dose extended cycle regimens)
South Korea	20090094437	METHODS OF HORMONAL TREATMENT UTILIZING ASCENDING-DOSE EXTENDED CYCLE REGIMENS

Supplementary Protection Certificates for QUARTETTE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1453521	15C0050	France		PRODUCT NAME: ETHINYLESTRADIOL ET MELANGE DE LEVONORGESTREL ET ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: NL 42237 20150320; FIRST REGISTRATION: SK - 17/0017/15-S 20150129
1380301	2009C/007	Belgium		PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
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	49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612
1453521	122015000093	Germany		PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
0136011	2000C/027	Belgium		PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124

QUARTETTE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Quartette

Introduction

Quartette, a unique extended-regimen oral contraceptive, was approved by the U.S. Food and Drug Administration (FDA) on March 29, 2013. Developed by Teva Women's Health, it offers a distinctive dosing regimen that gradually increases the estrogen dose, providing women with four short, light periods per year.

Market Need and Positioning

Quartette addresses a specific market need by offering an alternative to traditional 28-day cycle oral contraceptives. It is designed for women who prefer fewer menstrual periods, with only four scheduled periods per year. This makes it an attractive option for those seeking more period-free days, aligning with individual reproductive and contraceptive health needs[4].

Competitive Landscape

In the oral contraceptive market, Quartette stands out due to its ascending dose of estrogen. It competes with other extended-regimen contraceptives like Seasonique and Seasonale, but its unique dosing regimen sets it apart. This differentiation helps in capturing a specific segment of the market that values fewer menstrual periods[1][4].

Efficacy and Safety

The efficacy of Quartette was evaluated in a Phase III multicenter, open-label, single-arm study involving over 3,000 women. The study showed that Quartette was 97% effective in preventing pregnancy. Common adverse reactions included headaches, heavy/irregular vaginal bleeding, nausea/vomiting, and others. However, breakthrough bleeding and unscheduled spotting decreased over successive 91-day cycles, indicating improved tolerance over time[4].

Financial Performance

Since its approval, Quartette has contributed to Teva's revenue stream, although specific financial figures for Quartette alone are not publicly disclosed. However, the overall performance of Teva Women's Health can provide insights into the market acceptance and financial trajectory of the drug.

Revenue Impact

Teva's financial reports do not break down revenue by specific products like Quartette, but the company's focus on women's health products indicates that such offerings are significant contributors to their revenue. The introduction of Quartette and similar products has helped Teva maintain a strong presence in the women's health market[4].

Market Penetration

The success of Quartette can be gauged by its market penetration and the number of prescriptions written. While exact numbers are not available, the drug's unique selling proposition and the backing of a major pharmaceutical company like Teva have likely contributed to its adoption among healthcare providers and patients.

Pricing and Accessibility

Teva has implemented measures to make Quartette more accessible, such as offering a Quartette Savings Card. This initiative is part of the company's commitment to providing affordable birth control options, which can influence the drug's financial trajectory by increasing its market reach and patient adherence[4].

Regulatory Environment

The approval and continued use of Quartette are subject to regulatory oversight. The FDA's approval process and subsequent monitoring ensure that the drug meets safety and efficacy standards. Any changes in regulatory requirements or safety concerns could impact the financial performance of Quartette[1].

Consumer Preferences and Trends

Consumer preferences for fewer menstrual periods and more flexible contraceptive options have driven the demand for extended-regimen contraceptives like Quartette. As more women seek personalized reproductive health solutions, the market for such products is likely to grow, positively impacting the financial trajectory of Quartette[4].

Challenges and Risks

Despite its unique benefits, Quartette faces challenges such as increased bleeding or spotting between scheduled periods, especially in the initial cycles. Additionally, it carries the same serious risks as other hormonal contraceptives, including blood clots, cardiovascular events, and liver disease. These factors can affect patient adherence and, consequently, the drug's financial performance[4].

Future Outlook

The future outlook for Quartette is tied to the broader trends in the women's health market and the evolving preferences of consumers. As more women seek convenient and flexible contraceptive options, the demand for extended-regimen contraceptives is expected to grow. Teva's continued investment in women's health and its commitment to affordability and accessibility are likely to support the long-term financial trajectory of Quartette.

Key Takeaways

• Unique Selling Proposition: Quartette's ascending dose of estrogen and extended regimen set it apart in the market.
• Efficacy and Safety: High efficacy in preventing pregnancy, with common adverse reactions and decreasing breakthrough bleeding over time.
• Market Positioning: Addresses a specific need for fewer menstrual periods, capturing a niche market segment.
• Financial Performance: Contributes to Teva's revenue, with initiatives like savings cards enhancing accessibility.
• Regulatory and Consumer Trends: Subject to FDA oversight and driven by consumer preferences for flexible contraceptive options.

FAQs

1. What is the unique feature of Quartette compared to other oral contraceptives?

   • Quartette features an ascending dose of estrogen, gradually increasing at three distinct points over a 91-day cycle, allowing for only four scheduled periods per year[4].

2. How effective is Quartette in preventing pregnancy?

   • Quartette is 97% effective in preventing pregnancy, as demonstrated in a Phase III clinical trial[4].

3. What are the common side effects of Quartette?

   • Common side effects include headaches, heavy/irregular vaginal bleeding, nausea/vomiting, acne, dysmenorrhea, and others[4].

4. Does Quartette increase the risk of serious health issues?

   • Yes, like other hormonal contraceptives, Quartette increases the risk of serious blood clots, cardiovascular events, and liver disease, especially in women with other risk factors[4].

5. How does Teva make Quartette more accessible to patients?

   • Teva offers a Quartette Savings Card to make the drug more affordable and accessible to patients[4].

Cited Sources

1. FDA Clinical Review-Draft: "NDA 204061 Quartette (levonorgestrel/ethinyl estradiol)"[1].
2. Teva Press Release: "Teva Announces Quartette™ (levonorgestrel/ethinyl estradiol and ethinyl estradiol) Tablets Now Available in the U.S."[4].