ORTHO TRI-CYCLEN LO Drug Patent Profile

Which patents cover Ortho Tri-cyclen Lo, and when can generic versions of Ortho Tri-cyclen Lo launch?

Ortho Tri-cyclen Lo is a drug marketed by Janssen Pharms and is included in one NDA.

The generic ingredient in ORTHO TRI-CYCLEN LO is ethinyl estradiol; norgestimate. There are twenty-six drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norgestimate profile page.

Summary for ORTHO TRI-CYCLEN LO

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	5
Clinical Trials:	20
Patent Applications:	720
Drug Prices:	Drug price information for ORTHO TRI-CYCLEN LO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ORTHO TRI-CYCLEN LO
DailyMed Link:	ORTHO TRI-CYCLEN LO at DailyMed

See drug prices for ORTHO TRI-CYCLEN LO

See drug sales revenues for ORTHO TRI-CYCLEN LO

Recent Clinical Trials for ORTHO TRI-CYCLEN LO

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

Sponsor	Phase
Gilead Sciences	Phase 1
Lexicon Pharmaceuticals	Phase 1
Aegerion Pharmaceuticals, Inc.	Phase 1

See all ORTHO TRI-CYCLEN LO clinical trials

US Patents and Regulatory Information for ORTHO TRI-CYCLEN LO

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 TRI-CYCLEN LO	ethinyl estradiol; norgestimate	TABLET;ORAL-28	021241-001	Aug 22, 2002		DISCN	Yes	No

Expired US Patents for ORTHO TRI-CYCLEN LO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	ORTHO TRI-CYCLEN LO	ethinyl estradiol; norgestimate	TABLET;ORAL-28	021241-001	Aug 22, 2002	6,214,815*PED
Janssen Pharms	ORTHO TRI-CYCLEN LO	ethinyl estradiol; norgestimate	TABLET;ORAL-28	021241-001	Aug 22, 2002	4,530,839*PED
Janssen Pharms	ORTHO TRI-CYCLEN LO	ethinyl estradiol; norgestimate	TABLET;ORAL-28	021241-001	Aug 22, 2002	4,628,051*PED
Janssen Pharms	ORTHO TRI-CYCLEN LO	ethinyl estradiol; norgestimate	TABLET;ORAL-28	021241-001	Aug 22, 2002	4,616,006*PED
Janssen Pharms	ORTHO TRI-CYCLEN LO	ethinyl estradiol; norgestimate	TABLET;ORAL-28	021241-001	Aug 22, 2002	4,544,554*PED

International Patents for ORTHO TRI-CYCLEN LO

See the table below for patents covering ORTHO TRI-CYCLEN LO around the world.

Country	Patent Number	Title	Estimated Expiration
Slovakia	287931
World Intellectual Property Organization (WIPO)	0038691
Portugal	1140109
South Korea	20020027486
Russian Federation	2241709	ПРОИЗВОДНЫЕ АЗОТСОДЕРЖАЩИХ ГЕТЕРОЦИКЛИЧЕСКИХ СОЕДИНЕНИЙ И СПОСОБ ЛЕЧЕНИЯ РАССТРОЙСТВ, ХАРАКТЕРИЗУЮЩИХСЯ ПОРАЖЕНИЕМ НЕЙРОНОВ (DERIVATIVES OF NITROGEN-CONTAINING HETEROCYCLIC COMPOUNDS AND METHOD FOR TREATMENT OF DISORDERS WITH NEURONS INJURY)

Supplementary Protection Certificates for ORTHO TRI-CYCLEN LO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1453521	93156	Luxembourg		PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
1453521	39/2015	Austria		PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211
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
0771217	07C0001	France		PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
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: ORTHO TRI-CYCLEN LO

Last updated: July 31, 2025

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Introduction

Ortho Tri-Cyclen Lo, a combination oral contraceptive manufactured by Johnson & Johnson’s (J&J) Ortho-McNeil division, remains a significant product in the reproductive health space. As a low-dose monophasic estrogen-progestin contraceptive, it caters to a substantial demographic worldwide. Given the evolving landscape of contraceptive options, market dynamics influencing Ortho Tri-Cyclen Lo's performance, along with its financial trajectory, require comprehensive analysis rooted in current trends, regulatory considerations, and competitive forces.

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Market Dynamics

Global & Regional Market Overview

The global oral contraceptive market was valued at approximately USD 3.2 billion in 2022, with expected compound annual growth rates (CAGR) of around 4.8% through 2030 [1]. North America represents the largest share, driven by established healthcare infrastructure, high awareness, and favorable reimbursement policies. Asia-Pacific emerges as a high-growth region, driven by increasing acceptance, urbanization, and rising income levels.

Drivers of Market Growth

1. Rising Awareness & Acceptance: Increasing awareness about reproductive health and contraceptive options fuels demand. Governments and NGOs actively promote family planning, especially in developing regions, expanding the consumer base.

2. Product Innovation & Diversification: Advances in formulation technology, such as low-dose pills like Ortho Tri-Cyclen Lo, attract users seeking fewer side effects and improved safety profiles. These innovations extend product lifecycle and market viability.

3. Regulatory Environment: Favorable regulatory pathways in emerging markets facilitate quicker approval processes. However, regulatory hurdles for new formulations or indications can introduce delays or increase compliance costs.

4. Impact of Biosimilars & Alternatives: The emergence of long-acting reversible contraceptives (LARCs), including intrauterine devices (IUDs) and subdermal implants, pose substitution threats. Despite this, user preference shifts vary by region, maintaining stable demand for oral contraceptives like Ortho Tri-Cyclen Lo.

5. Market Entry Barriers: Established brands benefit from patent protections and entrenched healthcare provider preferences, though patent expirations threaten long-term exclusivity.

Competitive Landscape

Ortho Tri-Cyclen Lo faces competition from both branded and generic contraceptives. Generics offered by companies such as Teva and Mylan have eroded market share for branded products, exerting price pressures. Additionally, newer contraceptive methods (e.g., hormonal IUDs, implants) attract a segment of users seeking longer-term solutions.

Innovative products targeting specific populations—such as those with hormonal sensitivities—are also gaining ground. Pharmaceutical companies are investing in research to develop formulations with reduced side effects, which could threaten Ortho Tri-Cyclen Lo’s market position.

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Regulatory & Societal Influences

Regulatory Developments

Regulatory agencies like the FDA, EMA, and counterparts across Asia have been scrutinizing contraceptive safety profiles, particularly concerning cardiovascular risks and hormonal balance. The 2013 FDA regulations mandated stronger warnings for combination oral contraceptives, impacting pricing and market perception [2].

In emerging markets, regulatory pathways are streamlined but require rigorous clinical data to meet local safety standards. Patent expirations and biosimilar entry in key regions can profoundly influence market share and pricing strategies.

Societal Trends

Growing emphasis on women’s rights and reproductive autonomy enhances the demand for oral contraceptives. However, societal backlash in certain regions and legislative restrictions (e.g., in some U.S. states or countries with conservative policies) can impede market expansion.

The COVID-19 pandemic also introduced disruptions in supply chains and access to healthcare services, temporarily impacting distribution and consumption patterns.

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Financial Trajectory

Revenue Trends

Johnson & Johnson’s contraceptive segment, which includes Ortho Tri-Cyclen Lo, historically contributed significantly to its pharmaceutical revenue. Although precise sales data for Ortho Tri-Cyclen Lo are proprietary, industry estimates suggest steady global sales exceeding USD 300 million annually prior to patent expirations [3].

Given segment maturity and rising generic competition, revenue growth has slowed. Nevertheless, J&J’s strategic focus on expanding into emerging markets and diversifying reproductive health portfolios sustains revenue streams.

Profitability & Pricing Strategies

Price erosion due to generics coupled with patent expirations constrains profitability. J&J employs bundled marketing strategies and maintains premium pricing in regions with high brand loyalty. Additionally, developing combination products with extended patent life and leveraging dosing convenience can boost margins.

Future Outlook

The patent protection for Ortho Tri-Cyclen Lo is anticipated to lapse in key markets by the mid-2020s. This will likely precipitate a sharp decline in sales unless new formulations or indications are developed. J&J’s pipeline and R&D investments—focused on non-oral options, extended-release formulations, and combination therapies—are critical for sustaining financial growth.

In the medium term, revenue from the oral contraceptive segment may stabilize or decline unless offset by expanding access in emerging markets and penetrating niche segments such as women with hormonal sensitivities.

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Strategic Considerations & Market Outlook

1. Patent & Portfolio Management: Active patent management and lifecycle extension strategies, including reformulations and combination variants, are essential to delay generic competition.

2. Market Penetration & Education: Strengthening presence in emerging markets via targeted marketing, education, and aligning with local reproductive health initiatives can unlock revenue potential.

3. Diversification & Innovation: Investing in alternative delivery methods—such as implants, patches, or intrauterine devices—could diversify revenue streams and expand the therapeutic scope.

4. Regulatory & Policy Navigation: Engaging proactively with regulatory agencies to facilitate approval processes for new formulations and navigating legislative changes remain vital.

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Key Takeaways

• Market stability for Ortho Tri-Cyclen Lo is increasingly challenged by generic competition and the rise of alternative contraceptive methods, especially long-acting reversible contraceptives (LARCs).

• Emerging markets present strategic growth opportunities but require adaptation to varying regulatory landscapes and healthcare infrastructure.

• Patent expirations between 2023-2025 will significantly impact sales, demanding proactive portfolio management and innovation.

• Product innovation and diversification into non-oral contraceptives will be critical to sustaining revenue levels amid evolving consumer preferences and competitive threats.

• Regulatory environments and societal attitudes will influence market access and acceptance. Stakeholders should monitor shifting policies and demographic trends in reproductive health.

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FAQs

1. How will patent expirations impact Ortho Tri-Cyclen Lo’s revenue?
Patent expirations in key markets around 2023-2025 will enable generic competitors to replicate the formulation, leading to substantial price erosion and declining sales unless the manufacturer develops new formulations or indications.

2. Are there emerging alternative contraceptive options threatening Ortho Tri-Cyclen Lo?
Yes. Long-acting reversible contraceptives like IUDs, implants, and new hormonal methods are gaining popularity owing to ease of use and high efficacy, reducing the relative market size for oral contraceptives.

3. What growth opportunities exist for Ortho Tri-Cyclen Lo in emerging markets?
Expanding access through localized marketing, price penetration strategies, and addressing unmet reproductive health needs provides a significant growth avenue, especially as awareness and healthcare infrastructure improve.

4. How does societal acceptance influence the market?
Societal attitudes towards contraception, legal restrictions, and cultural norms significantly influence demand. Supportive policies and educational campaigns can enhance market adoption.

5. What strategies should Johnson & Johnson pursue to maintain competitiveness?
Investing in product innovation, diversifying the contraceptive portfolio, engaging with regulatory agencies early, and expanding into high-growth regions are critical to sustaining market position and financial performance.

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References

[1] MarketWatch. "Global Contraceptive Market Size & Share Report 2022."

[2] U.S. Food and Drug Administration (FDA). "Contraceptive Labeling Revisions and Safety Considerations," 2013.

[3] IQVIA. "Pharmaceutical Market Data & Analysis," 2022.

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This comprehensive analysis aims to enable stakeholders to anticipate market shifts, plan strategic initiatives, and optimize investment decisions regarding Ortho Tri-Cyclen Lo.