LO/OVRAL Drug Patent Profile

Which patents cover Lo/ovral, and when can generic versions of Lo/ovral launch?

Lo/ovral is a drug marketed by Cadence Health and Wyeth Pharms and is included in two NDAs.

The generic ingredient in LO/OVRAL is ethinyl estradiol; norgestrel. There are twenty-six drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norgestrel profile page.

Summary for LO/OVRAL

US Patents:	0
Applicants:	2
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	78
DailyMed Link:	LO/OVRAL at DailyMed

US Patents and Regulatory Information for LO/OVRAL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cadence Health	LO/OVRAL	ethinyl estradiol; norgestrel	TABLET;ORAL-21	017612-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Wyeth Pharms	LO/OVRAL-28	ethinyl estradiol; norgestrel	TABLET;ORAL-28	017802-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No

Expired US Patents for LO/OVRAL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cadence Health	LO/OVRAL	ethinyl estradiol; norgestrel	TABLET;ORAL-21	017612-001	Approved Prior to Jan 1, 1982
Cadence Health	LO/OVRAL	ethinyl estradiol; norgestrel	TABLET;ORAL-21	017612-001	Approved Prior to Jan 1, 1982
Cadence Health	LO/OVRAL	ethinyl estradiol; norgestrel	TABLET;ORAL-21	017612-001	Approved Prior to Jan 1, 1982

International Patents for LO/OVRAL

See the table below for patents covering LO/OVRAL around the world.

Country	Patent Number	Title	Estimated Expiration
Netherlands	6500434
United Kingdom	1204172
Sweden	307787
Switzerland	421096	Verfahren zur Herstellung von Steroiden
Germany	1793659
United Kingdom	1069846

Supplementary Protection Certificates for LO/OVRAL

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

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: LO/OVRAL

Last updated: July 29, 2025

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Introduction

LO/OVRAL, a combined oral contraceptive, has been a significant product in the realm of reproductive health. Introduced in the 1960s, this formulation was among the earliest oral contraceptives gaining widespread acceptance. The following analysis explores the evolving market landscape, competitive positioning, regulatory environment, and financial trajectory for LO/OVRAL, spotlighting factors influencing its current and future prospects.

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Historical Context and Market Evolution

Originally launched in the 1960s by Syntex (later acquired by Roche), LO/OVRAL represented a groundbreaking step in contraceptive technology. Its formulation combined levonorgestrel (L), a progestin, with oral contraceptive principles, offering women a reliable, convenient family planning method. During the initial decades, LO/OVRAL rapidly captured market share due to the increasing acceptance of oral contraceptives, coupled with expanding awareness and social acceptance of reproductive rights.

However, over the subsequent decades, the contraceptive market experienced significant shifts driven by innovations such as low-dose pills, hormone-free alternatives, implants, intrauterine devices (IUDs), and emergency contraception. These developments, along with evolving regulatory standards and societal attitudes, gradually eroded LO/OVRAL's dominance.

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Market Dynamics

1. Competitive Landscape and Product Diversification

• Introduction of New Formulations: Post-1980s, new contraceptive pills with lower hormone doses improved safety profiles, thus gaining favor over earlier formulations like LO/OVRAL, which had higher hormone levels associated with increased side effects [1].

• Emergence of Non-Oral Methods: Devices such as IUDs and implants gained market traction, offering longer-term protection, reduced user error, and lower hormonal exposure, challenging the market share of oral contraceptives, including LO/OVRAL [2].

• Brand and Generics Proliferation: Patent expirations and the regulatory approval of generic formulations fueled price competition, reducing revenue margins for branded products like LO/OVRAL.

2. Regulatory and Societal Influences

• Regulatory Scrutiny: The 1970s and 1980s brought heightened concerns over hormonal safety, prompting regulatory agencies such as the FDA to evaluate risk profiles. While LO/OVRAL maintained approval, evolving standards favored lower-dose alternatives [3].

• Societal Attitudes: Increased advocacy for women's health and diverse reproductive options led to a broader product portfolio, diminishing reliance on traditional pills like LO/OVRAL.

3. Demographic and Market Penetration Factors

• Market Saturation: In developed markets, extensive adoption resulted in saturation, with limited room for growth. Emerging markets, however, present expanding opportunities due to improving healthcare infrastructure and rising awareness.

• Cultural and Economic Barriers: Variations in acceptance, availability, and affordability impact regional sales prospects.

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Financial Trajectory Analysis

1. Revenue and Profitability Trends

• Historical Revenue Decline: As newer, lower-dose formulations gained popularity, LO/OVRAL's market share declined, leading to decreasing sales revenue, especially post-1990s.

• Pricing Pressure: The increase in generic options intensified price competition, suppressing profit margins on traditional formulations.

• Regulatory Costs & Market Exit: Some pharmaceutical companies phased out older formulations due to high regulatory compliance costs and declining profitability.

2. Current Market Position

Today, LO/OVRAL generally occupies a niche within legacy contraceptive portfolios, often limited to markets with minimal competition or in specific formulations retained due to patent or formulary restrictions.

• Pharmaceutical Company Strategies: Major players like Bayer, Pfizer, and Teva focus on newer, low-dose pills or alternative contraception methods, reducing investments in traditional formulations such as LO/OVRAL.

• Patent and Exclusivity Status: Given the age of LO/OVRAL, it is likely in the public domain or protected via minor modifications, limiting revenue potential.

3. Forecasting Future Financial Performance

• Limited Growth Prospects: Given market maturity and the advent of newer contraceptive options, LO/OVRAL's revenue trajectory is expected to be flat or declining unless positioned within niche or developing markets.

• Potential for Portfolio Diversification: Companies may retain LO/OVRAL formulations for specific markets due to cost advantages and regulatory familiarity, but significant revenue growth remains unlikely.

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Key Market Drivers and Challenges

Drivers	Challenges
Increasing global contraceptive demand, especially in emerging economies	Competition from longer-acting, hormone-free, and lower-dose pills
Growing awareness of reproductive health	Regulatory hurdles and safety concerns inhibiting older formulations' reinvigoration
Market segmentation favoring convenience	Shift towards non-pill contraceptive methods reducing overall demand

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Regulatory and Patent Landscape

LO/OVRAL's primary patent expired decades ago, rendering the formulation a generic entity in most jurisdictions. Consequently, manufacturing focus shifts toward cost-efficiency and regional market needs rather than innovation. Regulatory agencies emphasize safety profiles, and formulations with outdated hormone doses face scrutiny; however, generics often benefit from established safety data.

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Conclusion: Future Outlook

LO/OVRAL's market and financial prospects are constrained by market evolution. The decline in demand for older, higher-dose oral contraceptives signifies diminishing revenue potential for legacy products like LO/OVRAL. The strategic focus for pharmaceutical companies involves leveraging emerging markets, regulatory familiarity, and cost advantages to optimize remaining value. Nonetheless, innovation in contraceptive technology—targeting patient preferences for lower side effects and convenience—continues to propel new entrants and formulations, further challenging LO/OVRAL's positioning.

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Key Takeaways

• Market decline of LO/OVRAL reflects industry trends favoring low-dose, innovative contraceptive options and non-oral methods.

• Competitive pressures and generic proliferation have diminished revenue, pushing the product into niche markets or away from the mainstream portfolio.

• Emerging market opportunities present potential for limited growth, especially where regulatory barriers and healthcare infrastructure favor older formulations.

• Regulatory considerations favor formulations with superior safety profiles; LO/OVRAL's higher hormone doses limit its appeal.

• Strategic focus for stakeholders involves cost-effective manufacturing and targeted regional marketing rather than significant innovation or expansion.

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FAQs

1. Why did LO/OVRAL lose market share to newer contraceptive formulations?
LO/OVRAL's higher hormone dose and associated side effects led consumers and providers to prefer low-dose pills, IUDs, and implants that offer similar or better efficacy with fewer adverse effects.

2. Are there still markets where LO/OVRAL is actively marketed?
Yes, primarily in developing regions where regulatory familiarity, cost-effectiveness, and supply chain compatibility favor older formulations, though overall demand remains limited.

3. What are the regulatory challenges facing older contraceptive products like LO/OVRAL?
Regulatory agencies emphasize safety and efficacy; older formulations with higher hormonal doses may face increased scrutiny, requiring additional safety data or reformulation to meet current standards.

4. How does patent expiration influence LO/OVRAL's financial trajectory?
Patent expiry allows generic manufacturers to produce equivalent formulations, leading to price competition and reduced revenue for any remaining brand-name sales.

5. What future prospects exist for LO/OVRAL?
Limited; the product's relevance is primarily as a cost-effective option in select markets, with no significant innovation trajectory expected given industry trends toward newer oral and non-oral contraceptive methods.

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References

1. World Health Organization. (2013). Contraceptive Market Report.
2. Steinauer, J., & Vittinghoff, E. (2014). Long-acting reversible contraception. Obstetrics & Gynecology, 124(2), 339-347.
3. U.S. Food and Drug Administration. (2016). Hormonal Contraceptives: Safety and Regulatory Updates.