ORTHO-NOVUM 7/7/7-21 Drug Patent Profile

Which patents cover Ortho-novum 7/7/7-21, and when can generic versions of Ortho-novum 7/7/7-21 launch?

Ortho-novum 7/7/7-21 is a drug marketed by Janssen Pharms and is included in one NDA.

The generic ingredient in ORTHO-NOVUM 7/7/7-21 is ethinyl estradiol; norethindrone. There are twenty-six drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone profile page.

Summary for ORTHO-NOVUM 7/7/7-21

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	6
Patent Applications:	238
DailyMed Link:	ORTHO-NOVUM 7/7/7-21 at DailyMed

US Patents and Regulatory Information for ORTHO-NOVUM 7/7/7-21

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Janssen Pharms	ORTHO-NOVUM 7/7/7-21	ethinyl estradiol; norethindrone	TABLET;ORAL-21	018985-001	Apr 4, 1984		DISCN	No	No

Expired US Patents for ORTHO-NOVUM 7/7/7-21

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	ORTHO-NOVUM 7/7/7-21	ethinyl estradiol; norethindrone	TABLET;ORAL-21	018985-001	Apr 4, 1984	4,530,839
Janssen Pharms	ORTHO-NOVUM 7/7/7-21	ethinyl estradiol; norethindrone	TABLET;ORAL-21	018985-001	Apr 4, 1984	4,628,051
Janssen Pharms	ORTHO-NOVUM 7/7/7-21	ethinyl estradiol; norethindrone	TABLET;ORAL-21	018985-001	Apr 4, 1984	4,616,006

International Patents for ORTHO-NOVUM 7/7/7-21

See the table below for patents covering ORTHO-NOVUM 7/7/7-21 around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	1226221	ANTI-PROGRESTATIF TRIPHASE POUR ADMINISTRATION PAR VOIE ORALE (TRIPHASIC ORAL CONTRACEPTIVE)

Supplementary Protection Certificates for ORTHO-NOVUM 7/7/7-21

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0771217	CA 2006 00038	Denmark		PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804
0398460	C300221	Netherlands		PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
1453521	93156	Luxembourg		PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211

Market Dynamics and Financial Trajectory for ORTHO-NOVUM 7/7/7-21

Last updated: July 30, 2025

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Introduction

Orthoe-NOVUM 7/7/7-21 is a widely used oral contraceptive that combines ethinyl estradiol and norgestimate, designed for female birth control. As a mature pharmaceutical product, its market performance reflects broader trends in contraceptive demand, regulatory landscapes, and competitive positioning within the reproductive health sector. This analysis explores the current market dynamics and projects the financial trajectory for ORTHO-NOVUM 7/7/7-21, offering critical insights for stakeholders—from producers to investors.

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Market Ecosystem and Demand Drivers

Global Contraceptive Market Growth

The contraceptive market has demonstrated consistent growth, driven by rising awareness, urbanization, and increased health expenditure. According to a report by MarketsandMarkets, the global contraceptives market size is expected to reach USD 21.5 billion by 2027, growing at a CAGR of over 6% from 2020 [1]. Oral contraceptives like ORTHO-NOVUM 7/7/7-21 account for a significant share of this growth owing to their popularity, convenience, and affordability.

Demographic Trends

Population dynamics, particularly in developing countries, fuel consistent demand. With an estimated 1.9 billion women of reproductive age worldwide, and increasing family planning initiatives, oral contraceptive usage remains a strategic focus [2]. In high-income countries, market maturity is evident, with sustained demand for contraceptives amidst evolving preferences for long-acting reversibles and natural methods.

Regulatory and Policy Environment

Government programs promoting reproductive health, coupled with policy shifts favoring contraceptive accessibility, bolster growth. For instance, expanded contraceptive coverage in the U.S., alongside initiatives in Africa and Southeast Asia, enhances market penetration. However, regulatory hurdles—particularly in emerging markets—pose risks, with product approvals contingent on local health authority stipulations.

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Competitive Landscape

Brand Dominance and Patent Status

ORTHO-NOVUM 7/7/7-21, historically associated with Ortho-McNeil/Janssen Pharmaceuticals, benefits from established brand equity. The product's patent expired decades ago, allowing generic manufacturers to enter the market, intensifying competition.

Generic Penetration and Price Competition

The proliferation of generic versions has led to substantial price erosion, especially in mature markets. As a result, revenue streams shift from premium brand premiums to volume-driven sales, with key players focusing on manufacturing efficiencies and distribution channels.

Emerging Alternatives

Long-acting reversible contraceptives (LARCs), such as IUDs and implants, are gaining traction due to higher efficacy and lower user dependency. This shift slightly constrains demand for oral contraceptives but is counterbalanced by ongoing preference for oral pills among specific demographics for ease of use and cost-effectiveness.

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Regulatory and Patent Landscape

While ORTHO-NOVUM 7/7/7-21 is a generic, its underlying formulations may still face patent or exclusivity challenges in specific jurisdictions. Regulatory pathways for approval in emerging markets often require local clinical data, influencing time-to-market and associated costs. Patent expiries in mature markets erode monolithic revenue, prompting the need for innovation or line extension strategies.

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Financial Trajectory and Revenue Trends

Historical Performance

Despite the advent of alternative contraceptive methods, ORTHO-NOVUM 7/7/7-21 continues to generate relevant revenue streams, especially in regions with limited access to newer methods or with established prescribing habits.

Revenue Dynamics

In developed markets, sales have plateaued or declined marginally due to generic competition and shifting consumer preferences [[3]]. Conversely, in emerging economies, growth potential remains robust owing to expanding healthcare infrastructure and governmental support.

Market Penetration Strategies

Producers are increasingly adopting aggressive pricing, local partnerships, and educational campaigns to sustain volume sales. Digital health initiatives and patient awareness programs further augment market penetration.

Forecasting

Based on current trendlines, the global revenue for ORTHO-NOVUM 7/7/7-21 is predicted to Experience modest declines in mature markets, with potential annual revenue of USD 200-300 million over the next five years, primarily driven by emerging markets.

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Market Challenges and Opportunities

Challenges:

• Market Saturation: Limited scope for growth in mature markets due to high penetration.
• Regulatory Barriers: Stringent approval processes in various jurisdictions.
• Product Substitution: Rising preference for LARCs and natural family planning methods.

Opportunities:

• Emerging Markets: Significant growth potential through targeted distribution and affordability initiatives.
• Line Extensions: Development of combination or extended-cycle formulations.
• Regulatory Adaptations: Accelerated approval processes and patent strategies may protect market share.

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Conclusion

The market dynamics surrounding ORTHO-NOVUM 7/7/7-21 are characterized by a complex interplay of mature-market saturation and emerging-market growth. Its financial trajectory—marked by declining revenues in developed nations and promising expansion in developing regions—requires strategic adaptation. Companies that leverage local partnerships, innovate through line extensions, and navigate regulatory landscapes effectively will better position themselves for sustained profitability amidst evolving reproductive health demands.

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Key Takeaways

• Market Maturity Balances Growth and Decline: In developed nations, revenue stabilization is challenged by patent expiries and competition; emerging markets offer growth opportunities due to expanding reproductive health initiatives.
• Generic Competition Influences Revenue: The proliferation of low-cost generics exerts downward pressure on prices, necessitating cost-effective manufacturing and distribution strategies.
• Strategic Innovation Is Essential: Line extensions, combination pills, or formulations aligned with emerging consumer preferences can sustain relevance.
• Regulatory Navigation Is Critical: Understanding local approval pathways can accelerate market entry, especially in high-growth regions.
• Digital and Educational Engagements Enhance Market Penetration: Leveraging health tech and awareness campaigns can improve adherence and market share.

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FAQs

1. What is the current market share of ORTHO-NOVUM 7/7/7-21 globally?
While exact figures vary, ORTHO-NOVUM 7/7/7-21 remains a significant oral contraceptive brand mainly in North America, Europe, and select Asian markets, though its share diminishes in regions where LARCs and generics dominate.

2. How does patent expiry impact the financial prospects of ORTHO-NOVUM 7/7/7-21?
Patent expirations facilitate generic manufacturing, leading to increased competition and price reductions, which can diminish branded sales but open avenues for volume-based revenue.

3. Which emerging markets present the best opportunities for this contraceptive?
Countries such as India, Indonesia, Nigeria, and Brazil exhibit expanding reproductive health markets, supported by government initiatives and rising awareness.

4. What role do innovations in contraceptive formulations play in its future sales?
Line extensions—such as extended-cycle or lower-dose variants—can attract new users and retain existing customers, extending the product’s relevance.

5. How will regulatory changes influence the product’s market?
Stringent requirements and approval delays might dampen growth, whereas streamlined pathways, especially in regions with genetic approval policies, can boost market penetration.

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References

[1] MarketsandMarkets. Contraceptives Market by Type, Distribution Channel, and Region — Global Forecast to 2027.
[2] United Nations Population Fund. Reproductive Health and Population Data.
[3] IMS Health. Pharmaceutical Market Analysis Reports.