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
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
1214076	C01214076/01	Switzerland		PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
1214076	49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612
1214076	SZ 49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON
0136011	2000C/027	Belgium		PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124

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

Last updated: July 29, 2025

Introduction

ORTHO-NOVUM 7/7/7-28, a combined oral contraceptive (COC), remains a significant player in the global pharmaceutical contraceptive market. Its market dynamics are shaped by evolving consumer preferences, regulatory landscapes, competitive pressures, and technological innovations. Understanding its financial trajectory involves examining sales performance, patent status, market penetration, and emerging trends influencing its future.

Market Overview

The global oral contraceptives market was valued at approximately USD 6.2 billion in 2021 and is projected to reach USD 8.5 billion by 2028, growing at a compound annual growth rate (CAGR) of 4.7% (source: MarketWatch). ORTHO-NOVUM 7/7/7-28, a 28-day monophasic combined oral pill introduced in the 1970s, historically represented a significant share of this market due to its long-standing reputation and widespread adoption.

Market Dynamics

1. Consumer Preferences and Demographic Shifts

Recent trends denote increased preference for low-dose and highly effective contraceptive pills, driven by consumer demand for safety, minimal side effects, and convenience. ORTHO-NOVUM 7/7/7-28’s fixed-dose formulation aligns with these preferences, though newer formulations with extended or continuous dosing are gaining popularity.

2. Regulatory Environment

Regulatory agencies such as the FDA in the United States and EMA in Europe have tightened safety monitoring for hormonal contraceptives. Recent updates, like contraindications for specific populations, influence market access and prescribing practices. ORTHO-NOVUM 7/7/7-28’s older formulation benefits from established approval status but faces challenges from newer, regulatory-approved options offering improved safety profiles.

3. Competitive Landscape

The contraceptive market is highly competitive, with numerous oral, injectable, transdermal, and intrauterine devices. New entrants, biosimilar products, and innovative drug delivery systems threaten traditional pills' market share. Notably, levonorgestrel-releasing intrauterine systems (IUS) and progestin-only pills attract consumers seeking alternatives.

4. Patent Expiry and Generic Entry

The original patent protections for ORTHO-NOVUM 7/7/7-28 have expired or are approaching expiry in multiple jurisdictions, enabling generic manufacturers to enter the market. Generic competition typically results in significant price erosion, adversely affecting the product’s revenue potential.

5. Technological Innovations and New Delivery Systems

Advances such as continuous dosing, bioadhesive patches, and discreet delivery devices challenge the traditional oral pill market. While ORTHO-NOVUM 7/7/7-28 remains relevant, innovation-driven competitors often offer improved compliance or reduced side effects, pressuring older formulations' market share.

Financial Trajectory

1. Revenue Trends

Historical sales data indicate a steady decline in revenue from core formulations like ORTHO-NOVUM 7/7/7-28 in high-income markets, primarily due to generic competition, patent expiry, and premium product replacement. However, in emerging markets—Asia-Pacific, Latin America, and Africa—adoption remains robust due to limited access and lower penetration of newer options, sustaining a baseline revenue stream.

2. Impact of Patent and Market Entry

Once patent protections expire, revenues tend to decline sharply due to price competition and market saturation of generics. According to IQVIA data, US sales of branded oral contraceptives declined by approximately 15% post-generic entry between 2015-2020, with similar trends in Europe.

3. Geographic Variations

In developed markets (US, Europe), sales are plateauing or declining, while in developing regions, incremental growth boosts overall revenue. The affordability of generic versions in low and middle-income economies offsets the decline in branded sales.

4. Strategic Responses

Pharmaceutical companies have adopted strategies like portfolio diversification into long-acting reversible contraceptives (LARCs), expanding to non-oral delivery methods, and marketing to underserved populations to mitigate revenue erosion.

5. Future Outlook

The financial trajectory for ORTHO-NOVUM 7/7/7-28 is expected to follow a gradual decline in mature markets but sustain due to strong penetration in underserved regions. Innovations, such as forming alliances with local healthcare providers and expanding access, may slow obsolescence.

Emerging Trends Influencing Future Market Dynamics

a. Increased Use of Biosimilars and Generics

As patent expiry accelerates, biosimilars and generic equivalents flood markets, exerting downward pressure on prices and revenues. Regulatory pathways in emerging markets further facilitate this shift.

b. Preference for Non-Oral Contraceptives

The rising preference for non-oral options related to safety profiles and adherence issues may diminish the market share of traditional pills, including ORTHO-NOVUM 7/7/7-28.

c. Digital Health Integration

Digital adherence tools, telemedicine, and personalized contraceptive counseling influence consumer choices. Companies integrating these services can maintain relevance despite product commoditization.

d. Regulatory and Policy Shifts

Government initiatives promoting reproductive health and increasing access through subsidized or free contraceptives could stabilize demand in certain markets.

e. Social and Cultural Factors

Shifts in societal attitudes toward contraception, especially among younger populations, influence market size and growth potential, with increased openness leading to higher uptake.

Conclusion

Orthodox in its prime, ORTHO-NOVUM 7/7/7-28's market position has transformed with patent expirations, competitive innovations, and evolving consumer preferences. While its revenue base in mature markets wanes, growth potential persists in underserved regions. Companies that adapt through innovation, strategic regional focus, and portfolio diversification will better navigate the shifting landscape, balancing legacy product sales against emerging opportunities.

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Key Takeaways

• Market saturation and patent expiry have driven revenue declines in mature markets, intensifying competition from generics and biosimilars.
• Emerging markets sustain its financial trajectory, benefiting from lower generic penetration and increasing contraceptive demand.
• Innovations in drug delivery and digital health are reshaping contraceptive choices, with traditional pills facing obsolescence.
• Regulatory environments increasingly favor safer, more effective products, pressuring older formulations like ORTHO-NOVUM 7/7/7-28 to innovate or reposition.
• Strategic diversification into non-oral contraceptive products and regional expansion remains essential for sustaining revenues.

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FAQs

1. How does patent expiration affect the revenue of ORTHO-NOVUM 7/7/7-28?
Patent expiry allows generic manufacturers to produce cheaper alternatives, significantly reducing brand-name sales and profit margins. This typically results in a sharp decline in revenue unless mitigated by strategic diversification.

2. What regional markets are most promising for ORTHO-NOVUM 7/7/7-28?
Emerging markets such as India, Southeast Asia, Africa, and Latin America offer more opportunities due to lower penetration of newer contraceptive methods and higher demand, making these regions vital for sustained revenues.

3. How are technological innovations impacting the traditional oral contraceptive market?
Innovations like long-acting reversible contraceptives (LARCs), non-oral delivery systems, and digital adherence tools are capturing consumer interest, challenging the market share of traditional oral pills.

4. What are the primary challenges faced by ORTHO-NOVUM 7/7/7-28 today?
Key challenges include aging formulations facing generic competition, regulatory pressures prioritizing safety, declining popularity in developed markets, and competition from newer, more convenient methods.

5. What strategies can pharmaceutical companies adopt to prolong the relevance of legacy contraceptives?
Companies should focus on regional marketing, improving formulation safety profiles, integrating digital health solutions, and expanding into complementary contraceptive methods or combination products.

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Sources:
[1] MarketWatch, Global Contraceptive Market Forecast, 2022-2028
[2] IQVIA, Pharmaceutical Sales Data, 2021-2022
[3] FDA Regulatory Announcements, 2022
[4] Research and Markets, Contraceptive Market Trends, 2023