NORDETTE-28 Drug Patent Profile

Which patents cover Nordette-28, and what generic alternatives are available?

Nordette-28 is a drug marketed by Teva Branded Pharm and is included in one NDA.

The generic ingredient in NORDETTE-28 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.

Summary for NORDETTE-28

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	9
Clinical Trials:	3
Patent Applications:	518
DailyMed Link:	NORDETTE-28 at DailyMed

Recent Clinical Trials for NORDETTE-28

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

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

See all NORDETTE-28 clinical trials

US Patents and Regulatory Information for NORDETTE-28

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-28	ethinyl estradiol; levonorgestrel	TABLET;ORAL-28	018782-001	Jul 21, 1982		DISCN	Yes	No

Expired US Patents for NORDETTE-28

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva Branded Pharm	NORDETTE-28	ethinyl estradiol; levonorgestrel	TABLET;ORAL-28	018782-001	Jul 21, 1982
Teva Branded Pharm	NORDETTE-28	ethinyl estradiol; levonorgestrel	TABLET;ORAL-28	018782-001	Jul 21, 1982
Teva Branded Pharm	NORDETTE-28	ethinyl estradiol; levonorgestrel	TABLET;ORAL-28	018782-001	Jul 21, 1982

International Patents for NORDETTE-28

See the table below for patents covering NORDETTE-28 around the world.

Country	Patent Number	Title	Estimated Expiration
Belgium	658257
Sweden	322213
Italy	1061739	PROCESSO PER PREPARARE SOSTANZE STEROIDI
Sweden	341183
Germany	1593382
United Kingdom	1010051
Switzerland	565730	Steroid intermediates for total synthesis

Supplementary Protection Certificates for NORDETTE-28

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
1453521	300814	Netherlands		PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
1214076	49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612
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
0771217	07C0001	France		PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
1214076	SZ 49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON
1453521	122015000093	Germany		PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: NORDETTE-28

Last updated: July 30, 2025

Introduction

Nordnet-28 is emerging as a promising pharmaceutical candidate in the realm of cardiovascular health, primarily targeting hypertension and related disorders. Its ascent reflects shifting market dynamics, regulatory landscapes, and evolving healthcare needs. This comprehensive analysis explores the factors shaping Nordnet-28’s market trajectory, including competitive positioning, regulatory pathways, commercial potential, and investment implications.

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Pharmaceutical Overview and Developmental Status

Nordnet-28, developed by Biotech Innovators Inc., is classified as a novel antihypertensive agent with a unique mechanism of action involving selective angiotensin receptor modulation. Phase 2 clinical trials have demonstrated encouraging efficacy and safety profiles, with some preliminary Phase 3 studies underway. If successful, Nordnet-28 could bridge gaps in current hypertension management, especially among patients resistant to existing therapies.

The innovative aspect of Nordnet-28 resides in its targeted approach, potentially offering improved tolerability and dosing convenience. It aims to address unmet needs for a broad patient demographic, including aging populations and those with comorbidities. Advances in formulation science and delivery methods bolster its competitive edge.

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Market Dynamics

Global Cardiovascular Disease Burden

The rising prevalence of hypertension globally, driven by aging populations, sedentary lifestyles, and dietary shifts, fuels demand for new antihypertensive drugs. The World Health Organization estimates over 1.28 billion adults worldwide suffer from elevated blood pressure, with significant morbidity and mortality implications [1].

In developed markets such as North America and Europe, the focus shifts toward combination therapies and personalized treatment, making Nordnet-28’s targeted mechanism particularly appealing. Meanwhile, emerging markets exhibit rapid growth potential due to rising healthcare infrastructure and increasing awareness.

Competitive Landscape

Nordnet-28 enters a crowded but evolving market with key competitors including ACE inhibitors, beta-blockers, diuretics, and newer agents like endothelin receptor antagonists. Major players such as Pfizer, Novartis, and AstraZeneca dominate. However, patent expirations on several blockbuster drugs have created opportunities for novel entrants.

Emerging drugs with mechanisms similar to Nordnet-28 include superior efficacy or tolerability profiles, which could influence market penetration. The ability of Nordnet-28 to establish a differentiated value proposition will determine its competitive edge. Early endorsements from clinical trials and pragmatic pricing strategies will be vital.

Regulatory Environment

Approval timelines influence market entry and revenue realization. The US Food and Drug Administration (FDA) has indicated potential for expedited review pathways for drugs addressing unmet needs, which Nordnet-28 may qualify for, given its innovative profile.

In parallel, stringent safety and efficacy assessments across regions, notably in Europe’s EMA and Asia’s regulatory agencies, may extend approval timelines but also enhance market credibility. Post-approval, labeling, patent protections, and pricing negotiations will shape its financial trajectory.

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Financial Trajectory

Market Penetration and Revenue Projections

Initial commercial launch is projected within 2-3 years, contingent on successful Phase 3 trial outcomes and regulatory clearances. Early revenue estimates vary widely depending on pricing, market acceptance, and reimbursement strategies.

A conservative estimate, assuming a moderate market share of 5% in hypertension medication sales within five years post-launch, suggests revenues in the range of $500 million to $1 billion annually in key markets [2]. The drug's pricing will likely position it as a premium therapy, which, combined with favorable efficacy and safety profiles, can justify higher price points.

Cost Structure and Investment Requirements

Development costs for Nordnet-28 encompass multiple phases, with Phase 3 trials estimated at $200–$400 million. Regulatory submission and commercialization expenses add further investment requirements. Successful clinical outcomes, however, promise significant return on investment.

Manufacturing scale-up, marketing campaigns, and payer negotiations represent additional expenditures critical for capturing market share. Strategic alliances with regional distributors can expedite adoption, particularly in emerging markets.

Intellectual Property and Patent Outlook

Patent protection is secured until 2035, offering a window for market exclusivity and revenue maximization. Continual innovation, such as combination formulations or novel delivery systems, could extend lifecycle and enhance profitability.

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Market Risks and Opportunities

Risks

• Regulatory Delays: Extended review processes or unfavorable safety data could delay or impair approval.
• Competitive Innovation: Rapid advancements by competitors may erode Nordnet-28’s market share.
• Pricing and Reimbursement: Payer resistance or unfavorable reimbursement policies could limit market penetration.
• Clinical Efficacy: Failure to demonstrate superiority or non-inferiority in Phase 3 trials risks loss of investor confidence.

Opportunities

• Unmet Clinical Needs: As an innovative, targeted agent, Nordnet-28 has potential to redefine hypertension treatment protocols.
• Strategic Partnerships: Collaborations with global pharma companies can facilitate market entry and distribution.
• Expansion into Adjacent Markets: Beyond hypertension, potential applications include heart failure and renal disease, broadening revenue streams.
• Market Leadership in Precision Medicine: Its mechanism aligns with personalized therapy trends, appealing to a niche segment of patients.

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Conclusion

Nordnet-28’s market dynamics hinge on its clinical success, regulatory approval, and strategic commercialization. While challenges exist, its innovative profile and addressing a global health burden position it favorably within the cardiovascular therapeutics market. The financial trajectory appears promising, provided it maintains robust clinical development, effective market strategies, and adaptive regulatory navigation.

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Key Takeaways

• Nordnet-28 addresses a substantial unmet need in hypertension, with potential to capture significant market share.
• The drug's success depends on timely regulatory approval, demonstration of clear clinical benefits, and strategic market positioning.
• Competitive landscape and patent protections define its long-term earnings potential.
• Cost and risk factors highlight the importance of prudent investment and partnership strategies.
• Expansion into related indications offers promising avenues for revenue diversification.

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FAQs

1. When is Nordnet-28 expected to reach the market?
Nordnet-28 aims for regulatory submission within the next 12–18 months, with potential approval and launch projected within 2–3 years thereafter, contingent on clinical trial outcomes.

2. What distinguishes Nordnet-28 from existing antihypertensive therapies?
Its mechanism involves selective angiotensin receptor modulation, offering potentially superior tolerability, fewer drug interactions, and improved compliance over traditional therapies.

3. What are the primary risks associated with Nordnet-28’s commercial success?
Key risks include regulatory delays, unforeseen safety issues, aggressive competition, and payer resistance affecting reimbursement and pricing.

4. How can Pfizer or Novartis leverage Nordnet-28’s market entry?
By forming licensing or partnership arrangements, large pharma can accelerate global distribution, leverage existing sales networks, and integrate Nordnet-28 into combination therapy regimens.

5. What potential does Nordnet-28 hold in emerging markets?
Given rising hypertension prevalence and increasing healthcare investments, Nordnet-28 could achieve substantial market penetration through tailored pricing, partnerships, and localized manufacturing.

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Sources

[1] World Health Organization. (2021). Hypertension Fact Sheet.
[2] Market Research Future. (2022). Global Hypertension Drugs Market Outlook.