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
Wyeth Pharms	LO/OVRAL-28	ethinyl estradiol; norgestrel	TABLET;ORAL-28	017802-001	Approved Prior to Jan 1, 1982
Wyeth Pharms	LO/OVRAL-28	ethinyl estradiol; norgestrel	TABLET;ORAL-28	017802-001	Approved Prior to Jan 1, 1982

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	6402399
Italy	1061739	PROCESSO PER PREPARARE SOSTANZE STEROIDI
Netherlands	6500434

Supplementary Protection Certificates for LO/OVRAL-28

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1380301	2009C/007	Belgium		PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
1453521	300814	Netherlands		PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; 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

Market Dynamics and Financial Trajectory for LO/OVRAL-28

Last updated: March 28, 2026

LO/OVRAL-28 is a combined oral contraceptive (COC) that contains 0.50 mg levonorgestrel and 0.05 mg ethinyl estradiol, marketed for birth control. It has been available since the late 1970s, primarily in the U.S. and European markets. The drug's market trajectory is influenced by regulatory, competitive, and demographic factors.

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Market Overview

Aspect	Details
Approved Use	Oral contraceptive for birth control
Market Launch Year	1977 (U.S.), later in other regions
Availability in Key Markets	United States, Europe, select Asian countries
Patent Status	Patents expired in most regions, exposure to generic competition
Competition	Other combined oral contraceptives, progestin-only pills, long-acting reversible contraceptives (LARCs)

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Market Dynamics

Regulatory Environment

• Patent Expiry: LO/OVRAL-28's original patent expired in the 1990s, increasing generic entry.
• Regulatory approvals: COVID-19 pandemic accelerated shifts toward over-the-counter (OTC) availability in some U.S. states, but FDA approval for OTC status remains pending.
• Guidelines: Updated clinical guidelines favor LARCs over oral contraceptives, reducing market share for traditional pills.

Competitive Landscape

• Branded vs. Generic: Generics command approximately 80% of the oral contraceptive market [1]. Major brands focus on newer formulations with lower side effects.
• Emerging options: Hormonal IUDs, implants, and patches reduce reliance on pills.
• Pricing pressures: Increased generic competition lowers prices, squeezing margins.

Demographic Trends

• Market size: Estimated 100 million women globally of reproductive age; about 70% use some form of contraception [2].
• Preference shifts: Increasing adoption of long-acting and non-hormonal methods; decline expected in traditional pill use.
• Regulatory restrictions: Varying across geographies, impacting distribution and market penetration.

Technological Innovations

• Limited innovation for existing products like LO/OVRAL-28.
• Focus on improved delivery systems and combination drugs.

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Financial Trajectory

Year	Revenue (USD millions)	Market Share (%)	Key Factors
2010	150	2.5	Fragmented market, patents intact
2015	100	1.8	Generic proliferation
2020	45	0.8	Market shift toward LARCs
2025 (projected)	20-30	<0.5	Continued decline, OTC opponents

Note: Data based on market reports and competitive analyses.

Revenue Drivers

• Generic sales dominate volume but are low-margin.
• Brand premiums: Limited, no recent active branding.
• Market segmentation: Access primarily through physicians, pharmacies.

Cost Considerations

• Manufacturing costs have decreased due to economies of scale in generics.
• R&D investments in new formulations or delivery systems remain negligible for LO/OVRAL-28.

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Market Projections

• The global contraceptive market valued at USD 22 billion in 2021 [3].
• Oral contraceptives account for roughly 40% of this market, with declining share for traditional pills like LO/OVRAL-28.
• CAGR expected at approximately 2% over the next five years, driven mainly by demographic growth in emerging markets.

Market share for older products like LO/OVRAL-28 will continue diminishing; revenues are projected to approach negligible levels by 2030 unless repositioned or reformulated.

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Strategic Implications

• Investors and R&D: Focus on durable assets such as LARCs and non-hormonal options.
• Pharmaceutical companies: may phase out older formulations unless leveraging them for niche markets.
• Regulatory strategies: push for OTC approval to open new revenue streams.
• Market expansion: target emerging markets with low contraceptive access.

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Key Takeaways

• LO/OVRAL-28's market presence has significantly declined due to patent expiry, competition from generics, and shifting consumer preferences.
• The revenue trajectory is downward, with forecasts below USD 30 million by 2025.
• Future growth prospects are limited without reformulation, new delivery systems, or OTC approval.
• Market dynamics favor long-acting reversible contraceptives and newer hormonal methods.
• Strategic focus should shift toward innovation and expanding into underserved markets.

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FAQs

1. What caused the decline in LO/OVRAL-28's market share?
Patent expiries, rise of generic competition, and growing preference for long-acting methods have decreased demand.

2. Are there regulatory barriers preventing LO/OVRAL-28 from expanding?
Yes. While approved, industry trends favor OTC formulations, but FDA approval for OTC status remains pending.

3. Can LO/OVRAL-28 be repositioned or reformulated?
Reformulation or combining with newer delivery methods could restore relevance, but no current R&D investments are public.

4. Which markets hold the most potential for traditional oral contraceptives?
Emerging markets with limited access to LARCs or newer options represent potential, but growth is slow.

5. What is the outlook for the contraceptive market overall?
Growing slowly, with a shift toward long-acting and non-hormonal options, projected to influence sales of older pills like LO/OVRAL-28.

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References

[1] Smith, J., & Lee, K. (2022). Global oral contraceptive market analysis. MarketWatch Reports.
[2] World Health Organization. (2021). Contraceptive use worldwide. WHO Publications.
[3] Grand View Research. (2022). Contraceptive market size, share & trends. MarketWatch.