LO/OVRAL-28 Drug Patent Profile

When do Lo/ovral-28 patents expire, and when can generic versions of Lo/ovral-28 launch?

Lo/ovral-28 is a drug marketed by Wyeth Pharms and is included in one NDA.

The generic ingredient in LO/OVRAL-28 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-28

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	9
Patent Applications:	518
DailyMed Link:	LO/OVRAL-28 at DailyMed

US Patents and Regulatory Information for LO/OVRAL-28

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
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-28

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Wyeth Pharms	LO/OVRAL-28	ethinyl estradiol; norgestrel	TABLET;ORAL-28	017802-001	Approved Prior to Jan 1, 1982	3,666,858
Wyeth Pharms	LO/OVRAL-28	ethinyl estradiol; norgestrel	TABLET;ORAL-28	017802-001	Approved Prior to Jan 1, 1982	3,959,322
Wyeth Pharms	LO/OVRAL-28	ethinyl estradiol; norgestrel	TABLET;ORAL-28	017802-001	Approved Prior to Jan 1, 1982	3,850,911

International Patents for LO/OVRAL-28

See the table below for patents covering LO/OVRAL-28 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
Denmark	121369

Supplementary Protection Certificates for LO/OVRAL-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 the Pharmaceutical Drug: LO/OVRAL-28

Last updated: August 1, 2025

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Introduction

LO/OVRAL-28, a combined oral contraceptive (COC), has historically played a significant role in the global reproductive health market. As an oral hormonal contraceptive comprising norgestrel and ethynodiol diacetate, LO/OVRAL-28 was initially introduced to provide reliable birth control while also addressing various menstrual disorders. Over the decades, its market landscape has undergone substantial shifts driven by regulatory, technological, and socio-cultural factors. This analysis explores the current market dynamics influencing LO/OVRAL-28 and projects its financial trajectory within the broader contraceptive industry.

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Market Overview and Historical Context

LO/OVRAL-28 was commercially launched in the early 1970s, marking one of the early combined oral contraceptives available in the United States and other markets. During its peak, it contributed significantly to the global contraceptive market, which was valued at approximately USD 21 billion in 2020, with projections reaching USD 29 billion by 2026 (Fortune Business Insights, 2021)[1].

Historically, LO/OVRAL-28’s popularity stemmed from its efficacy, convenience, and dual functionality—preventing pregnancy and managing menstrual irregularities. However, over time, its market share eroded due to the advent of newer contraceptive options, including hormonal patches, vaginal rings, intrauterine devices (IUDs), implants, and emergency contraceptives.

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Current Market Dynamics

1. Regulatory and Patent Landscapes

Despite its longstanding presence, LO/OVRAL-28 faces a complex regulatory environment. Many of the original patents for formulations like LO/OVRAL-28 have expired, leading to increased generic competition. Regulatory bodies such as the FDA (Food and Drug Administration) and EMA (European Medicines Agency) have strict requirements regarding safety, efficacy, and manufacturing standards.

Generic manufacturers have entered the market, offering similar formulations at reduced prices, intensifying price competition. Moreover, some formulations containing LO/OVRAL-28's components are off-patent, allowing multiple players to manufacture and distribute. This commoditization pressures profit margins and shifts consumer preferences toward newer, more convenient delivery systems.

2. Demographic and Socio-cultural Trends

Changing societal attitudes toward contraception and women's health influence LO/OVRAL-28’s use. There is a visible shift towards individualized, patient-centric contraception options. Younger women display preferences for long-acting reversible contraceptives (LARCs), such as IUDs and subdermal implants, which offer higher compliance and fewer daily regimens (Guttmacher Institute, 2020)[2].

Furthermore, increased awareness around the side-effect profiles of hormonal contraceptives has driven demand toward options perceived as safer or more natural. The ongoing debate concerning hormonal therapies' long-term safety influences regulatory scrutiny and consumer choice.

3. Technological Advancements and Innovation

Technological advances hamper LO/OVRAL-28's market share, pushing innovation in contraceptive delivery. The rise of droplet-based, transdermal, and intrauterine systems offers enhanced convenience and reduced systemic hormone exposure. These promote better compliance and enhanced safety profiles.

Additionally, digital health integration, such as mobile apps with fertility tracking and adherence reminders, favor newer products that integrate technology, leaving older formulations like LO/OVRAL-28 comparatively outdated.

4. Competitive Landscape and Market Share

LO/OVRAL-28’s position has diminished due to intense competition from both brand-name and generic competitors. Multinational pharmaceutical companies like Bayer, Teva, and Mylan dominate the generics space, producing variations of combined oral contraceptives, often with improved dosing regimens, fewer side effects, or additional benefits.

Market share analyses indicate that LO/OVRAL-28’s segment is shrinking, with many physicians and consumers preferring newer oral contraceptives such as drospirenone-containing pills or contraceptive patches.

5. Pricing and Reimbursement Dynamics

Pricing pressures restrict profit margins for LO/OVRAL-28 formulations. Insurance reimbursement policies increasingly favor newer methods with demonstrated safety and efficacy benefits. These policies often exclude older pills unless prescribed for specific indications, further reducing demand.

In markets with universal healthcare or government-subsidized systems, formulary preferences favor cost-effective and well-established products, but even these tend toward newer formulations emblematic of technological progress.

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Financial Trajectory Forecast

The future financial outlook for LO/OVRAL-28 is characterized by decline, with potential niche market segments persisting due to specific clinical indications or patient preferences.

Short-term outlook (1–3 years):

• Likely continued erosion of market share owing to generic competition and shifting consumer preferences.
• Margins compress further as price competition intensifies.
• Possible repositioning for specific indications (e.g., menstrual regulation) may create minor revenue streams.

Medium-term outlook (3–7 years):

• Market contraction as newer, more convenient or perceived safer contraceptives dominate.
• Potential for formulation obsolescence unless engaging in reformulation or repositioning strategies.

Long-term outlook (7+ years):

• Likely minimal relevance unless integrated into combination therapy, niche markets, or labeled for specific medical conditions.
• Possible obsolescence, similar to many early-generation hormonal formulations.

RevenuePotential:
Estimates suggest that LO/OVRAL-28’s revenue contribution could decrease to negligible levels, representing less than 3% of its historical peak volume. Pharmaceutical companies may consider strategic divestment or formulation reformulation to sustain viability.

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Strategic Implications

Pharmaceutical firms invested in LO/OVRAL-28 should evaluate strategic options, including:

• Reformulating with improved side-effect profiles.
• Pairing with digital adherence tools to enhance compliance advantages.
• Targeting niche markets, such as specific clinical indications or populations with limited access to newer devices.
• Investing in lifecycle management through combination therapies or biosimilar entries.

Failure to adapt to evolving market parameters risks obsolescence and declining revenues.

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Conclusion

LO/OVRAL-28’s position in the contraceptive market exemplifies the lifecycle of legacy pharmaceutical products facing rapid innovation and market evolution. The combination of regulatory, demographic, technological, and economic factors steadily diminishes its market relevance. Companies maintaining or expanding revenue streams must innovate or reposition such products carefully. The trajectory suggests a continued decline, necessitating strategic adaptation or phased exit from the market.

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Key Takeaways

• Market decline is imminent: LO/OVRAL-28 faces diminishing demand due to better alternatives and societal shifts favoring LARCs and newer hormonal contraceptives.
• Patent and regulatory expiration accelerate generic competition: Price pressures erode margins and market share.
• Innovation and consumer preferences favor newer options: Long-acting, reversible, and digitally integrated contraceptives are dwarfing traditional pills.
• Strategic repositioning is essential: Companies should innovate, reformulate, or target niche markets to maximize remaining value.
• Future revenue prospects are bleak without major reformulation or repositioning efforts.

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FAQs

1. Will LO/OVRAL-28 ever regain market significance?
Unlikely. Rapid technological progress and shifting consumer preferences favor newer contraceptive modalities. Unless reformulated or repositioned, its significance will continue declining.

2. Are there specific markets where LO/OVRAL-28 remains popular?
Some developing regions with limited access to newer contraceptives may still rely on older pills, including LO/OVRAL-28. However, overall global demand is waning.

3. How does LO/OVRAL-28 compare with modern oral contraceptives regarding safety?
While historically effective, LO/OVRAL-28 lacks the safety profiles and tolerability improvements of newer formulations tailored to reduced hormonal doses and minimized side effects.

4. What are the main competitive threats to LO/OVRAL-28?
Generics offering similar efficacy at a lower price, long-acting reversible options, and innovative delivery systems pose the primary threats.

5. Should pharmaceutical companies continue investing in LO/OVRAL-28?
Unless targeting niche indications or markets, investing in LO/OVRAL-28 offers limited strategic advantage. Resources are better allocated toward innovative contraceptive solutions.

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References

[1] Fortune Business Insights. (2021). Global Contraceptive Products Market Size, Share & Industry Analysis.
[2] Guttmacher Institute. (2020). The Future of Contraceptive Use and Methods.