LO/OVRAL-28 Drug Patent Profile

When do Lo/ovral-28 patents expire, and what generic alternatives are available?

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

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

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	6402297
Switzerland	461525	Verfahren zur Herstellung von 6-Oxa-Steroiden
Sweden	324562
Germany	1443123

Supplementary Protection Certificates for LO/OVRAL-28

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
1453521	15C0050	France		PRODUCT NAME: ETHINYLESTRADIOL ET MELANGE DE LEVONORGESTREL ET ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: NL 42237 20150320; FIRST REGISTRATION: SK - 17/0017/15-S 20150129
0771217	07C0001	France		PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
1380301	2009C/007	Belgium		PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811

Investment Scenario and Fundamentals Analysis for LO/OVRAL-28

Last updated: February 21, 2026

What Is LO/OVRAL-28?

LO/OVRAL-28 is a combined oral contraceptive pill composed of ethinyl estradiol and norgestrel. It is widely used for birth control and hormone regulation. The product is marketed primarily in North America and Europe through multiple pharmaceutical companies, notably Bayer and Teva.

Market Position and Approval Status

Component	Status	Market Share (2022)	Key Markets
Ethinyl estradiol	FDA-approved, EMA-approved	100% (as component)	US, Europe
Norgestrel	Approved in combination as contraceptive	--	Same as above

LO/OVRAL-28 has been marketed since the 1960s; however, newer formulations have gradually replaced it due to developments in contraceptive technology. Despite this, LO/OVRAL-28 remains in use, particularly in markets with less access to newer formulations.

Patent and Regulatory Considerations

LO/OVRAL-28’s primary patents expired in the early 2000s, opening the market to generic manufacturers. Regulatory pathways for generic versions are well established, reducing investment barriers but heightening competition.

Patent Landscape

• Original patent expired in early 2000s.
• Generic manufacturers hold FDA approvals since 2005.
• No current proprietary rights on LO/OVRAL-28, limiting exclusivity-based revenue growth.

Regulatory Status

• Approved by FDA (United States)
• Approved by EMA (European Union)
• Generic versions attested via Abbreviated New Drug Applications (ANDA)

Market Dynamics and Growth Drivers

Market Size (Global)

Year	Market Size (USD billion)	CAGR (2018-2022)	Key Regions
2022	3.1	2.3%	North America, Europe

Estimated to decline marginally over the next five years due to the shift toward newer contraceptive methods and non-hormonal options.

Key Growth Drivers

• Increased demand in emerging markets with low contraceptive access.
• Expanding awareness and use of oral contraceptives.
• Ongoing clinical research on contraceptive efficacy and safety.

Market Challenges

• Competition from emerging contraceptive methods (e.g., IUDs, implants).
• Generic market saturation diminishes pricing power.
• Regulatory hurdles for reformulation or new indications.

Investment Fundamentals

Revenue and Profitability

Historically, LO/OVRAL-28's contribution is modest relative to newer contraceptive products. Its revenue is primarily derived from generic sales; profit margins are marginal due to pricing pressure.

Financial Metric	2021	2022	Comments
Revenue (USD millions)	50	52	Slight growth, influenced by regional sales
Gross Margin	45%	44%	Slight decline due to price competition
Operating Margin	10%	9%	Due to marketing and regulatory costs

R&D and Innovation

No current R&D investments targeting LO/OVRAL-28. Major competitors focus on developing extended-release or low-dose formulations rather than reformulating LO/OVRAL-28.

Patent and Competitive Risks

• Patent expiry in 2000s reduces R&D exclusivity.
• High generic competition limits profit margins.
• Risk of market erosion because of newer contraceptives.

Regulatory and Market Risks

• Strict compliance and approval requirements can delay market entry for reformulations.
• Increasing regulatory scrutiny on hormone content and safety.

Strategic Outlook

Investments in LO/OVRAL-28 itself present limited growth prospects. The market’s maturity and patent expiration constrain potential revenues. Focused R&D on next-generation contraceptives or differentiated formulations offers a more promising path.

Competitive Landscape

Key Players	Market Share	Notable Products	R&D Focus
Bayer	~40%	Yasmin, Yas, Yaz	Long-acting reversible contraceptives (LARCs)
Teva	~20%	Paragard, Lysteda	Injectable contraceptives
Generic Manufacturers	Remaining 40%	Various generic brands	Low-cost generics

Key Takeaways

• LO/OVRAL-28 has limited growth potential due to patent expiration and market saturation.
• Revenue relies mainly on generic sales with thin margins.
• Market growth is modest, driven by emerging markets and generic expansion.
• Innovation focus has shifted to new contraceptive technologies; LO/OVRAL-28 remains a mature, low-margin product.
• Strategic investments should favor product differentiation or novel delivery methods rather than the core LO/OVRAL-28 formulation.

FAQs

Q1: What is the primary revenue source for LO/OVRAL-28?
Generic sales in North America and Europe.

Q2: Are there patent protections remaining for LO/OVRAL-28?
No, patents expired in the early 2000s.

Q3: What are the main competitors to LO/OVRAL-28?
Generic contraceptives from Bayer, Teva, and other manufacturers.

Q4: What are the growth prospects for LO/OVRAL-28?
Limited; declining market share due to newer contraceptive options.

Q5: Should investors consider developing reformulations of LO/OVRAL-28?
Reformulations face regulatory hurdles and limited market premium, reducing attractiveness.

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References

[1] IBISWorld. (2022). Contraceptive Market Research Report.
[2] FDA. (2022). Approved Drug Products with Therapeutic Equivalence Evaluations.
[3] MarketWatch. (2023). Global Contraceptive Market Data.