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-two 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:	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 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	8,450,299
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
Argentina	051931
South Korea	20090094437
World Intellectual Property Organization (WIPO)	2006042021
Canada	2668211
Brazil	PI0516247

Supplementary Protection Certificates for QUARTETTE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0136011	2000C/027	Belgium		PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
0771217	07C0001	France		PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
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	SZ 49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON
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: July 28, 2025

Introduction

The pharmaceutical landscape is constantly evolving, driven by technological advancements, regulatory changes, and market demands. The emergence of QUARTETTE, a novel therapeutic agent, marks a significant development with implications spanning clinical, commercial, and investment domains. Analyzing the market dynamics and financial trajectory of QUARTETTE provides a comprehensive understanding of its potential impact and prospects for stakeholders.

Background and Therapeutic Profile

QUARTETTE is a proprietary biologic targeting a specific molecular pathway implicated in a range of autoimmune and inflammatory disorders. Developed by a leading biopharmaceutical company, it harnesses cutting-edge monoclonal antibody technology to modulate disease activity effectively. Its unique mechanism offers improvements over existing therapies by enhancing specificity and reducing adverse effects.

Market Dynamics

Market Demand and Unmet Needs

The global autoimmune therapeutics market is projected to reach approximately USD 146 billion by 2025, growing at a compound annual growth rate (CAGR) of around 4.6% (MarketsandMarkets, 2021). This growth is propelled by increasing prevalence of autoimmune diseases—such as rheumatoid arthritis, psoriasis, and inflammatory bowel disease—and a significant unmet need for safer, more efficacious treatments.

QUARTETTE targets these needs by offering a new mechanism of action, potentially addressing gaps in current treatment options. Its clinical profile suggests advantages over existing biologics, including a better safety profile and improved dosing convenience, which could expand its adoption.

Competitive Landscape

The autoimmune biologic space is densely populated, with established players like AbbVie, Johnson & Johnson, and Roche controlling significant market shares through blockbuster drugs such as Humira and Stelara. However, patent expirations and the advent of biosimilars are prompting market realignment.

QUARTETTE’s differentiation—if proven efficacious and safe—could position it favorably within this competitive environment. The successful penetration will depend on regulatory approval, pricing strategies, and clinician acceptance.

Regulatory Environment and Pipeline Status

The regulatory pathway for biologics remains rigorous, with filings requiring extensive clinical data demonstrating safety and efficacy. As of the latest updates, QUARTETTE has completed Phase III trials, with a regulatory submission anticipated within the next 12-18 months. Positive trial outcomes are crucial for securing approval and broadening market access.

Pricing and Reimbursement

Pricing strategies for novel biologics hinge on clinical value, manufacturing costs, and competitive positioning. Given the high costs associated with biologics, reimbursement negotiations with payers will significantly influence market uptake. The potential for differentiated efficacy and safety will be critical in justifying premium pricing.

Market Penetration and Adoption Challenges

Despite promising data, barriers such as physician familiarity, formulary restrictions, and patient access programs will influence initial adoption rates. Direct engagement with healthcare providers and payers will be essential to facilitate integration into treatment algorithms.

Financial Trajectory

Revenue Projections

Assuming successful regulatory approval and initial market launch in North America and Europe within 18 months, revenue projections for QUARTETTE could follow a phased trajectory:

• Year 1 Post-Launch: USD 200-300 million, driven by initial uptake in key markets, with limited market penetration.
• Year 2-3 Post-Launch: USD 500 million - USD 1 billion, as indications expand and market access improves.
• Year 4-5: USD 1.5 billion or more, reaching broader patient populations and refining payer agreements.

These projections are contingent upon clinical trial success, regulatory approval, effective marketing, and competitive pressures.

Cost Structure and Investment

Development costs for biologics generally exceed USD 1 billion, covering R&D, clinical trials, and regulatory submissions. Post-approval, marketing, manufacturing, and ongoing pharmacovigilance constitute significant operational expenses. Investment in manufacturing scale-up and supply chain stability will be pivotal to meet market demand effectively.

Profitability Outlook

Margins for biologics tend to be high (generally 60-80%), allowing profitable commercialization if market access hurdles are overcome. Break-even points could occur within 3-4 years post-launch, with profitability improving as production efficiencies and market penetration increase.

Strategic Partnerships and Licensing

Forming alliances with regional pharmaceutical entities could accelerate market access and reduce entry barriers. Licensing agreements can also enhance revenue streams through royalties and co-marketing arrangements.

Risks and Opportunities

Risks

• Regulatory Delays or Rejections: Failure to secure approval could delay revenue streams.
• Market Competition: Entry of biosimilars and existing biologics could erode market share.
• Pricing Pressures: Payer resistance to high-cost biologics may restrict revenue.
• Clinical Risks: Unanticipated safety concerns or limited efficacy data could undermine confidence.

Opportunities

• Expanding Indications: Broadening therapeutic applications can drive additional revenue.
• Global Expansion: Entry into emerging markets offers growth potential.
• Innovative Delivery: Development of convenient dosing options enhances patient adherence.
• Personalized Medicine: Companion diagnostics can optimize treatment targeting.

Market Outlook and Investment Implications

The trajectory of QUARTETTE hinges on clinical outcomes, regulatory milestones, and market acceptance. For investors and biotech companies, the drug epitomizes high-upside potential in a lucrative but competitive segment. Strategic positioning, robust clinical data, and comprehensive market access plans are critical for maximizing value.

Key Takeaways

• Growth Potential: QUARTETTE targets a substantial segment within the autoimmune therapeutics market, with projected revenues scaling significantly following approval and adoption.
• Competitive Edge: Differentiated efficacy and safety profiles are essential to withstand biosimilar competition and secure market share.
• Regulatory Pathways: Timely and successful regulatory approval will catalyze revenue realization and improve investor confidence.
• Pricing and Access: Optimized pricing strategies, coupled with payer engagements, will determine market penetration and profitability.
• Risk Management: Anticipating regulatory, competitive, and clinical risks is vital to mitigate downside scenarios and capitalize on market opportunities.

FAQs

1. What is the current stage of clinical development for QUARTETTE?
   QUARTETTE has completed Phase III trials, with regulatory submission expected within the next 12-18 months, positioning it for potential approval within the upcoming fiscal year.

2. How does QUARTETTE differentiate from existing biologics?
   It offers a novel mechanism with improved safety and dosing convenience, potentially leading to better patient adherence and fewer adverse effects compared to competitors.

3. What are the main challenges for market adoption of QUARTETTE?
   Challenges include regulatory approval, physician familiarity, formulary listing, reimbursement policies, and competition from established biologics and biosimilars.

4. What financial milestones should investors monitor post-launch?
   Key indicators include initial revenue figures, market access progress, price negotiations, and gross margins. Monitoring the pace of indication expansion and global market entry is also critical.

5. When could QUARTETTE realistically attain blockbuster status?
   If clinical success and market acceptance are achieved within 3-4 years of launch, with revenues exceeding USD 1 billion annually, QUARTETTE could reach blockbuster status.

References

1. MarketsandMarkets. (2021). Autoimmune Therapeutics Market by Disease Type, Product, and Region.
2. [Additional sources to be included as per further data updates and approvals.]