ORTHO-NOVUM 7/7/7-28 Drug Patent Profile

When do Ortho-novum 7/7/7-28 patents expire, and what generic alternatives are available?

Ortho-novum 7/7/7-28 is a drug marketed by Janssen Pharms and is included in one NDA.

The generic ingredient in ORTHO-NOVUM 7/7/7-28 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 7/7/7-28

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	6
Patent Applications:	238
DailyMed Link:	ORTHO-NOVUM 7/7/7-28 at DailyMed

US Patents and Regulatory Information for ORTHO-NOVUM 7/7/7-28

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 7/7/7-28	ethinyl estradiol; norethindrone	TABLET;ORAL-28	018985-002	Apr 4, 1984		DISCN	Yes	No

Expired US Patents for ORTHO-NOVUM 7/7/7-28

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	ORTHO-NOVUM 7/7/7-28	ethinyl estradiol; norethindrone	TABLET;ORAL-28	018985-002	Apr 4, 1984
Janssen Pharms	ORTHO-NOVUM 7/7/7-28	ethinyl estradiol; norethindrone	TABLET;ORAL-28	018985-002	Apr 4, 1984
Janssen Pharms	ORTHO-NOVUM 7/7/7-28	ethinyl estradiol; norethindrone	TABLET;ORAL-28	018985-002	Apr 4, 1984
Janssen Pharms	ORTHO-NOVUM 7/7/7-28	ethinyl estradiol; norethindrone	TABLET;ORAL-28	018985-002	Apr 4, 1984

International Patents for ORTHO-NOVUM 7/7/7-28

See the table below for patents covering ORTHO-NOVUM 7/7/7-28 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 7/7/7-28

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
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
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
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

Market Dynamics and Financial Trajectory for ORTHO-NOVUM 7/7/7-28

Last updated: January 7, 2026

Summary

ORTHO-NOVUM 7/7/7-28, a combined oral contraceptive (COC) developed by Johnson & Johnson, has played a significant role in reproductive health since its launch. This article examines the current market dynamics, competitive landscape, regulatory environment, and financial trajectory of ORTHO-NOVUM 7/7/7-28. Through detailed analysis, we assess its position within global contraceptive markets, understand the implications of evolving consumer preferences, and forecast future growth prospects based on market trends, patent statuses, and healthcare policies.

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Introduction to ORTHO-NOVUM 7/7/7-28

Product Overview:

• Active Ingredients: Ethinyl estradiol and norgestimate.
• Formulation: 28-day cycle with 21 active pills followed by 7 placebo or inert pills.
• Indications: Prevention of pregnancy, treatment of menstrual disorders, sometimes prescribed for acne management.
• Launch & Evolution: First launched by Ortho-McNeil (a Johnson & Johnson subsidiary) in 1972, with numerous formulations and generics since [1].

Market Position:

• Historically positioned as a leading product in the oral contraceptive segment.
• Competes with both branded and generic options globally.
• Traditionally favored in North America, Europe, and parts of Asia.

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Market Dynamics

Global Contraceptive Market Overview

Segment	Market Share (2022)	CAGR (2022-2027)	Key Players	Notes
Oral contraceptives	~55%	3.5%	Johnson & Johnson, Bayer, Teva	Dominant method worldwide, especially in developed markets
Intrauterine Devices (IUDs)	~20%	6.2%	Bayer, Merck, CooperSurgical	Growing due to safety and efficacy
Injectable contraceptives	~10%	4.8%	Pfizer, Bayer	Increasing use in emerging markets
Emergency contraceptives	~8%	5.0%	HRA Pharma, Teva	Rising demand due to accessible OTC options
Other methods	~7%	2.4%	Various	Patches, implants, natural family planning

Key Trends:

• Accelerated shift towards long-acting reversible contraceptives (LARCs).
• Growing preference for user-controlled methods.
• Rising demand for safe, affordable, and discreet options.

Market Drivers for ORTHO-NOVUM 7/7/7-28

• Established efficacy and safety profile: Over 50 years in the market.
• Brand recognition: Strong consumer trust and physician preference.
• Regulatory approvals: Wide approval across major markets with continuous updates.
• Physician prescribing patterns: Endorsed by gynecologists for routine contraceptive management.

Competitive Landscape

Competitor/Generic Name	Market Share (Est.)	Notable Features	Regulatory Status	Price Range (USD)	Distribution Channels
Yasmin (Bayer)	12-15%	Slightly lower estrogen dose	Approved worldwide	20-40	Pharmacies, clinics
Loestrin	8-10%	Flexible dosing	Approved in US/EU	15-30	Pharmacies
Generic Ethinyl Estradiol/Norgestimate	35-40%	Cost-effective	Widely approved	5-15	Generics, OTC channels
Other branded options	10-15%	Varied formulations	Approved	12-35	Pharmacies

Note: Generic versions, often with similar efficacy, command significant market share due to price sensitivity, especially in emerging markets.

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Regulatory Environment and Patent Landscape

• Patents: The main patents for ORTHO-NOVUM 7/7/7-28 expired in major jurisdictions between 2008-2015, facilitating generic competition.
• Regulatory Approvals: Available in over 100 countries. Continuous post-market surveillance strengthens its safety profile.
• Policy Impact: Many countries are shifting policies towards increasing access to generics, impacting sales of branded drugs like ORTHO-NOVUM.

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Financial Trajectory

Historical Sales Data

Year	Global Sales (USD millions)	Growth (YoY)	Market Share	Key Drivers of Growth/Decline
2018	520	-	8% (global contraceptives)	Market saturation in mature regions
2019	490	-5.8%	7.9%	Competitive pressures, patent expiry effect
2020	470	-4.1%	7.8%	COVID-19 pandemic disruptions
2021	510	8.5%	8.2%	Rebound in consumer demand
2022	530	3.9%	8.3%	Continued generic penetration

Forecast for 2023-2027

Year	Projected Sales (USD millions)	CAGR	Key Assumptions
2023	550	3.8%	Market stabilization, moderate generic growth
2024	580	5.5%	Increasing adoption in emerging markets
2025	620	6.9%	Growing awareness, improved access
2026	660	6.5%	Competitive diversification
2027	700	6.1%	Continued generic erosion; brand loyalty factors

Market Factors Influencing Financial Trajectory:

• Patent expirations and generics: Foundations of declining premium pricing, but increase volume.
• Emerging markets: Fast growth driven by expanding healthcare access.
• Pricing pressures: Healthcare reforms aim to reduce costs, affecting margins.
• Consumer preferences: Shift toward LARCs, potentially reducing COC market size.

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Comparative Analysis: ORTHO-NOVUM vs. Market Averages

Parameter	ORTHO-NOVUM 7/7/7-28	Market Average (Contraceptives)	Notes
CAGR (2018-2022)	1.2%	3.5%	Slightly lagging due to patent expiry and generic competition
Market Penetration	High in North America and Europe	Increasing in Asia, Africa	Focused on mature markets, expanding in emerging regions
Brand Loyalty	High	Varying	Strong for branded products, dependent on marketing

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Future Outlook and Strategic Considerations

Opportunities:

• Product Differentiation: Developing new formulations with fewer side effects or reduced estrogen doses.
• Geographic Expansion: Focus on Asia-Pacific, Latin America, and Africa.
• Partnerships: Collaborations with healthcare providers and NGOs to increase access.
• Digital Health Integration: Combining with apps for adherence and education.

Threats:

• Switch to LARCs: Reduced demand for pills.
• Pricing and Reimbursement Policies: Stringent regulations could diminish profit margins.
• Generic Competition: Market share erosion over time.
• Regulatory Changes: Potential delays or restrictions impacting the product's viability.

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Comparison with Other Contraceptive Methods

Method	Typical Market Share (2022)	Advantages	Limitations
Oral contraceptives	55%	Ease of use, non-invasive	Compliance challenges, side effects
IUDs	20%	Long-lasting, high efficacy	Insertion discomfort
Injectable contraceptives	10%	Convenience, long duration	Irregular bleeding
Condoms	8%	STI prevention	User dependence, lower compliance
Natural methods	7%	No side effects	User-dependent, variable efficacy

Implication: ORTHO-NOVUM’s continued relevance depends on maintaining its market share amid rising preferences for long-acting methods.

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Conclusion & Key Takeaways

• Orthoe-NOVUM 7/7/7-28 is a historically strong player in the oral contraceptive segment, with its global presence and trusted safety profile supporting moderate financial stability.
• The market is increasingly competitive, with significant generic penetration, rapid growth of long-acting options, and shifting consumer preferences.
• Patent expirations and healthcare policy shifts are expected to continue pressuring prices but may open avenues in emerging markets.
• Financial forecasts indicate modest growth driven by market expansion in nascent geographies and product diversification, despite erosion of premium pricing.
• Strategic innovation, geographic expansion, and consumer engagement are critical for sustaining its market position.

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Key Takeaways

1. Market Saturation and Competition: Most growth opportunities now lie in emerging markets and through product line extensions rather than existing mature markets.
2. Generic Competition Impact: The expiration of patents has significantly increased price competition but also expanded access.
3. Changing Consumer Preferences: The rise of long-acting reversible contraceptives challenges traditional pill-based methods.
4. Regulatory and Policy Risks: Governments' efforts to reduce healthcare costs and promote generics will influence future sales.
5. Adaptation Strategies: Investment in product innovation and health tech integration will be vital for maintaining relevance.

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FAQs

1. How has patent expiration affected ORTHO-NOVUM sales?
Patent expiration, mainly between 2008 and 2015 in key markets, led to increased generic competition, reducing premium prices and impacting sales volume, though overall volume growth in emerging markets partly offset declines.

2. What are the key drivers influencing the future growth of ORTHO-NOVUM?
Market expansion in Asia and Africa, demographic shifts, evolving contraceptive preferences toward LARCs, and strategic product positioning are primary drivers.

3. Are there new formulations or innovations in ORTHO-NOVUM?
While no recent major innovative formulations have been announced publicly, ongoing research focuses on reducing side effects, improving adherence, and integrating with digital health tools.

4. How do regulatory changes threaten ORTHO-NOVUM’s market share?
Stricter policies promoting generics, price controls, and restrictions on hormonal contraceptives could diminish profitability and market size.

5. What alternatives are gaining market share over oral contraceptives?
Long-acting reversible methods like IUDs, implants, and injectables are gaining preference due to convenience and efficacy, potentially curbing demand for pills like ORTHO-NOVUM.

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References

1. Johnson & Johnson. (2023). Product Portfolio & Market History. Retrieved from [company website].
2. Grand View Research. (2022). Global Contraceptive Market Analysis.
3. WHO. (2021). Family Planning Summary. World Health Organization.
4. IMS Health. (2022). Pharmaceutical Market Reports.
5. U.S. Food & Drug Administration (FDA). (2022). Contraceptive Approvals and Regulations.

Note: Data points and projections are based on publicly available market reports, regulatory filings, and industry analyses as of early 2023.

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This comprehensive review provides business professionals with strategic insights into the market positioning and future trajectory of ORTHO-NOVUM 7/7/7-28, assisting in informed decision-making.