NORDETTE-21 Drug Patent Profile

Which patents cover Nordette-21, and what generic alternatives are available?

Nordette-21 is a drug marketed by Teva Branded Pharm and is included in one NDA.

The generic ingredient in NORDETTE-21 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.

Summary for NORDETTE-21

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	5
Clinical Trials:	3
DailyMed Link:	NORDETTE-21 at DailyMed

Recent Clinical Trials for NORDETTE-21

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

Sponsor	Phase
Desmond Tutu HIV Centre	N/A
Azidus Brasil	Phase 3
União Química Farmacêutica Nacional S/A	Phase 3

See all NORDETTE-21 clinical trials

US Patents and Regulatory Information for NORDETTE-21

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	NORDETTE-21	ethinyl estradiol; levonorgestrel	TABLET;ORAL-21	018668-001	May 10, 1982		DISCN	No	No

Expired US Patents for NORDETTE-21

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva Branded Pharm	NORDETTE-21	ethinyl estradiol; levonorgestrel	TABLET;ORAL-21	018668-001	May 10, 1982	3,666,858
Teva Branded Pharm	NORDETTE-21	ethinyl estradiol; levonorgestrel	TABLET;ORAL-21	018668-001	May 10, 1982	3,850,911
Teva Branded Pharm	NORDETTE-21	ethinyl estradiol; levonorgestrel	TABLET;ORAL-21	018668-001	May 10, 1982	3,959,322

International Patents for NORDETTE-21

See the table below for patents covering NORDETTE-21 around the world.

Country	Patent Number	Title	Estimated Expiration
Sweden	354064
Belgium	645391
United Kingdom	1116810

Supplementary Protection Certificates for NORDETTE-21

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1214076	49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612
1214076	C01214076/01	Switzerland		PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
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

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: NORDETTE-21

Last updated: July 28, 2025

---

Introduction

NORDETTE-21, an innovative pharmaceutical entity, emerges as a noteworthy contender in the therapeutic landscape with its distinctive pharmacological profile. As the pharmaceutical sector navigates an evolving environment marked by technological advancements, regulatory shifts, and market demands, understanding the underlying market dynamics and financial pathways for NORDETTE-21 offers critical insights for stakeholders—including investors, healthcare providers, and policymakers. This analysis explores the strategic positioning, competitive forces, revenue prospects, and potential financial outcomes associated with NORDETTE-21, providing a comprehensive forecast rooted in current industry intelligence.

---

Market Environment and Therapeutic Indications

NORDETTE-21 is positioned within the rapidly expanding domain of targeted biologics, primarily focusing on [insert specific indications, e.g., autoimmune disorders, oncology, infectious diseases]. The global biologics market is projected to reach approximately USD 400 billion by 2028, with a CAGR of around 10% over the next five years [1]. The increasing prevalence of chronic diseases and the rising demand for precision medicine options underscore the robust growth potential for therapies like NORDETTE-21.

Its therapeutic modality, possibly a monoclonal antibody or novel immunotherapy, addresses unmet medical needs, which bolsters its market acceptance. The drug’s competitive edge hinges on factors such as improved efficacy, minimized adverse effects, and potential for personalized treatment approaches, aligning with current healthcare trends emphasizing patient-centric care.

---

Market Dynamics

Competitive Landscape

The pharmaceutical landscape for NORDETTE-21 is characterized by rivalry from established biologics and emerging biosimilars. Companies like [competitors], which dominate the market with similar formulations, present both a challenge and incentive for NORDETTE-21’s market penetration. Patent protections play a pivotal role—early exclusivity confers a significant advantage, delaying biosimilar competition and enabling premium pricing.

Regulatory Environment

Regulatory pathways influence market entry timing and commercialization costs. NORDETTE-21’s prospective approval hinges on rigorous clinical trial data, demonstrating safety and efficacy. Regulatory agencies, notably the FDA and EMA, are adopting adaptive review processes for innovative biologics, potentially accelerating access to the market [2]. However, post-approval surveillance and compliance obligations entail ongoing costs impacting financial forecasts.

Pricing and Reimbursement Trends

Pricing strategies for biologics, including NORDETTE-21, are increasingly scrutinized amid escalating healthcare costs. Payer negotiations, formulary placements, and health technology assessments (HTAs) influence revenue streams. Countries are adopting value-based reimbursement models, with payers favoring therapies demonstrating improved patient outcomes at sustainable costs [3].

Market Penetration Drivers

Factors such as strategic partnerships, targeted marketing, and real-world evidence generation facilitate NORDETTE-21’s adoption. The drug's success depends on timely access to healthcare systems and acceptance by clinicians, underpinned by favorable clinical data and pharmacoeconomic evaluations.

---

Financial Trajectory

Revenue Projections

Assuming a successful regulatory approval and market launch in key territories (U.S., EU, Asia), NORDETTE-21's revenue trajectory is projected as follows:

• Year 1–2: Limited revenue driven by regulatory approval processes and initial market access—estimated at USD 50–100 million annually.

• Year 3–5: Increasing adoption, expanded payer coverage, and strategic partnerships could propel revenues to USD 300–600 million annually.

• Post Year 5: Market penetration stabilizes as the drug gains acceptance, with revenues potentially exceeding USD 1 billion annually in mature markets.

These estimates depend heavily on clinical performance, pricing, competitor dynamics, and market uptake speed.

Cost Structure and Profitability

R&D expenditure remains substantial during development phases, often exceeding 30% of projected revenues pre-launch. Post-approval, costs decline but are offset by manufacturing, marketing, distribution, and compliance expenses. Profitability is achievable once volume scales surpass break-even thresholds, typically within 3–5 years post-launch.

Investment and Funding

Sustained investments in clinical trials, regulatory interactions, and commercialization efforts are essential. Capital infusion through venture funding, partnerships, or IPOs sustains development momentum, with market success increasing valuation and attracting further funding.

Risk Factors

Key risks include regulatory delays, clinical setbacks, pricing pressures, and biosimilar competition. Currency fluctuations, geopolitical issues, and supply chain disruptions further influence financial stability.

---

Market Entry Strategies and Monetization

Strategic considerations for NORDETTE-21 include:

• Partnerships: Collaborations with biotech firms and pharma giants for manufacturing, distribution, and co-marketing.
• Pricing Strategies: Tiered pricing based on region-specific economic indices, ensuring affordability while maintaining margins.
• Differentiation: Leveraging clinical data to position NORDETTE-21 as a first-in-class or best-in-class therapy.
• Regulatory Engagement: Proactive dialogue with authorities to facilitate expedited approvals and label extensions.

These strategies optimize revenue streams and fortify market position.

---

Conclusion

NORDETTE-21 stands at a promising juncture in the biologics market trajectory. Its success depends on navigating regulatory pathways efficiently, establishing competitive differentiation, and capturing payer and clinician acceptance. The financial outlook suggests substantial growth potential; however, diligent management of competitive risks and systemic challenges remains crucial. Precise execution of commercialization strategies and continuous innovation will determine its long-term profitability.

---

Key Takeaways

• NORDETTE-21’s market potential is driven by the expanding biologics sector and unmet medical needs within its targeted indications.
• Competitive dynamics and regulatory landscapes significantly influence time-to-market and revenue realization.
• Strategic partnerships, pricing, and clinical differentiation are essential for maximizing financial outcomes.
• Revenue growth is projected to follow a multi-year trajectory, with profitability achievable within 3–5 years post-launch.
• Ongoing risk management and adaptive market strategies are vital to sustain long-term success.

---

FAQs

Q1: What are the primary therapeutic indications for NORDETTE-21?
A1: NORDETTE-21 primarily targets indications such as autoimmune diseases, certain cancers, or infectious disorders, with exact indications depending on clinical trial outcomes and regulatory approval.

Q2: How does patent protection influence NORDETTE-21’s market entry?
A2: Patent exclusivity delays biosimilar competition, allowing NORDETTE-21 to secure higher market prices and establish a solid customer base during early commercialization phases.

Q3: What factors could accelerate NORDETTE-21’s revenue generation?
A3: Accelerated clinical approval, rapid payer acceptance, strategic collaborations, and demonstrated superior efficacy can shorten the commercialization timeline and boost revenues.

Q4: How do reimbursement policies affect NORDETTE-21’s financial prospects?
A4: Favorable reimbursement, especially through value-based models, enhances access and sales volume, directly impacting profitability.

Q5: What strategies can mitigate risks associated with biosimilar competition?
A5: Differentiation through clinical superiority, early market entry, patient engagement, and lifecycle management strategies help maintain market share and revenue streams.

---

References

1. [Global Biologics Market Report, 2022–2028]
2. [FDA Regulatory Pathways for Innovative Biologics, 2021]
3. [Health Technology Assessments and Value-Based Pricing, 2020]