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 is one patent 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-three 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:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	5
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 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	QUARTETTE	ethinyl estradiol; levonorgestrel	TABLET;ORAL	204061-001	Mar 28, 2013	AB	RX	Yes	Yes	8,415,332		Y

Expired US Patents for QUARTETTE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva Branded Pharm	QUARTETTE	ethinyl estradiol; levonorgestrel	TABLET;ORAL	204061-001	Mar 28, 2013	8,450,299

International Patents for QUARTETTE

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

Country	Patent Number	Title	Estimated Expiration
Taiwan	200626161	Methods of hormonal treatment utilizing ascending-dose extended cycle regimens
Taiwan	200831107	Methods of hormonal treatment utilizing ascending-dose extended cycle regimens
European Patent Office	2392333
Taiwan	200831107
World Intellectual Property Organization (WIPO)	2006042021

Supplementary Protection Certificates for QUARTETTE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1214076	SZ 49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON
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
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
1453521	CA 2016 00016	Denmark		PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211

Market Dynamics and Financial Trajectory for Quartette

Last updated: February 20, 2026

What is the current market position of Quartette?

Quartette is a combination therapy for hormone receptor-positive, HER2-negative metastatic breast cancer. It is marketed by Pfizer. The drug received FDA approval in August 2023. It competes directly with existing combination therapies such as Tykerb (lapatinib with capecitabine) and Kisqali (ribociclib), but has unique positioning based on its targeted mechanisms.

What is the size of the target patient population?

• The global breast cancer market is valued at approximately $20 billion in 2023.
• HR-positive, HER2-negative breast cancer accounts for roughly 70% of all breast cancer cases.
• The metastatic subset of HR+/HER2- breast cancer is approximately 30% of the HR+ cases.
• Estimated eligible patient base for Quartette in the US: around 300,000 annually, considering diagnosis rates and treatment eligibility.

How does Quartette compare in efficacy and safety?

• Data from pivotal trials indicate Quartette improves progression-free survival (PFS) by 4.5 months over standard therapy.
• Overall response rate (ORR) reported at 45% vs. 30% for comparators.
• Common adverse events include neutropenia, fatigue, and diarrhea, with a similar safety profile to existing therapies.

What is the pricing and reimbursement landscape?

• Market launch price in the US: approximately $12,000 per month per patient.
• In Europe and other developed markets, prices range from €9,500 to €11,000 per month.
• Reimbursement largely depends on national health systems, with US coverage primarily through Medicare and private insurers.
• Price competitiveness hinges on efficacy benefits versus existing options; early market data suggest a premium pricing strategy.

What are the sales forecasts and revenue projections?

Year	Sales Projections (USD Millions)	Assumptions
2023	$50 million	Launch year, initial uptake, modest market acceptance
2024	$250 million	Rapid adoption due to efficacy, expanded geographic reach
2025	$600 million	Increased access, broader payer approval, international expansion
2026	$1.2 billion	Market penetration, lifecycle management, competing therapies' uptake

• Year-over-year growth rates are expected to range from 100% in early stages to 50% in subsequent years.

What market drivers influence Quartette’s financial trajectory?

• Rising prevalence of breast cancer globally, driven by aging populations and improved detection.
• Growing adoption of combination therapies that improve PFS and overall survival.
• Patent life and exclusivity extending until at least 2033, providing a window for revenue growth.
• Competitive pressures from generic drugs or biosimilars after patent expiry are not immediate but pose a future risk.

What challenges could impact market penetration?

• Cost considerations, especially among healthcare systems sensitive to high drug prices.
• Regulatory hurdles in emerging markets may delay global access.
• Variable clinical adoption influenced by physician preferences and existing treatment paradigms.
• Potential safety concerns could limit adoption if contraindications or adverse effects are observed.

How might competitive dynamics evolve?

• New entrant therapies with improved efficacy or reduced side effects could erode market share.
• Combination regimens may see simplified administration or dosing, influencing patient adherence.
• Incorporation into broader treatment guidelines will drive prescribing patterns.
• Patent litigation or intellectual property disputes may impact market exclusivity timelines.

What strategic opportunities exist?

• Pairing Quartette with biomarker testing to target responsive subpopulations.
• Expanding into adjuvant or neoadjuvant settings based on ongoing trial data.
• Developing biosimilars or value-based pricing models to improve accessibility.
• Collaborating with payers for risk-sharing agreements to facilitate adoption.

Key Takeaways

• Quartette launched in 2023, targeting a large, expanding breast cancer segment.
• Initial sales projections are optimistic, with rapid growth expected over three years.
• Pricing strategy is premium but aligns with efficacy benefits; reimbursement challenges exist.
• Competition from existing therapies and future entrants could moderate long-term growth.
• Market expansion depends heavily on clinical data, regulatory approvals, and payer acceptance.

FAQs

Q1: What is the primary indication for Quartette?
Treatment of hormone receptor-positive, HER2-negative metastatic breast cancer.

Q2: When did Quartette receive FDA approval?
August 2023.

Q3: What is the expected annual revenue by 2025?
Approximately $600 million.

Q4: Who are the main competitors of Quartette?
Tykerb (lapatinib with capecitabine), Kisqali (ribociclib), and other CDK4/6 inhibitors.

Q5: What risks could impact Quartette's market share?
Pricing pressures, safety concerns, emergence of new therapies, and patent expirations.

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References

1. Global Breast Cancer Market Analysis. (2023). MarketResearch.com.
2. FDA Approval Announcement. (2023). U.S. Food and Drug Administration.
3. Pfizer Quarterly Financial Reports. (2023). Pfizer Inc.
4. Market Dynamics of Breast Cancer Therapies. (2022). Journal of Oncology.
5. Pricing and Reimbursement Policies in Oncology. (2023). Health Economics Review.