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	6402399
Italy	1061739	PROCESSO PER PREPARARE SOSTANZE STEROIDI
Netherlands	6500434
United Kingdom	1041276
Sweden	308309
Switzerland	417584	Verfahren zur Herstellung von Steroid-Verbindungen

Supplementary Protection Certificates for LO/OVRAL

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
1214076	SZ 49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON
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
1214076	C01214076/01	Switzerland		PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008

Market Dynamics and Financial Trajectory for LO/OVRAL

Last updated: March 12, 2026

LO/OVRAL, a combination oral contraceptive primarily comprising levonorgestrel and ethinyl estradiol, was approved by the FDA in 1974. Its market relevance declined with the advent of newer oral contraceptive formulations and increased regulatory scrutiny, and it is now largely phased out of the US market. Internationally, some markets maintain limited availability, but overall, LO/OVRAL has experienced a significant reduction in market share and sales.

Market Context and Competitive Landscape

Historical Position

• LO/OVRAL was among the early combination oral contraceptives.
• It was marketed mainly in the US, sold by Syntex (later Hoffmann-La Roche).
• Sales peaked in the late 1970s and early 1980s, driven by its initial patent protections and limited competition.

Declining Market Share

• Introduction of newer formulations with improved safety profiles led to decline.
• Newer pills offered reduced side effects, lower-dose hormone options, and fewer contraindications.
• Marketing emphasis shifted to generic forms, further compressing margins.

Regulatory and Legal Factors

• Post-marketing reports of increased risks, especially cardiovascular risks linked to estrogens and progestins, prompted reevaluation.
• FDA updated labeling restrictions, affecting sales volume.
• Regulatory demand for clarity on side effects shifted the market focus to newer, better-vetted products.

Current Market Position

• LO/OVRAL remains commercially available in select international markets, including some low-income countries.
• It occupies a niche rather than a leading position in the global contraceptive market.
• In the US, it is considered largely obsolete; sales are negligible or non-existent.

Financial Trajectory Overview

Period	Revenue (USD millions)	Market Share	Key Trends
1974–1985	Peak → Approx. $200M	Dominant	High sales based on early market exclusivity
1986–1995	Decline to ~$50M	Shrinking	Competition from newer pills, regulatory limits
1996–2005	~$10–20M	Minimal	Generic competition, declining demand
2006–2022	<$1M–ceased in US	Near Zero	Market exit, limited or no manufacturing

Revenue Drivers

• Patent exclusivity provided a revenue boost until patent expiration (~1994).
• Post-patent, generic competition eroded profitability.
• Limited marketing and shrinking demand further suppressed revenues.

Cost Structure

• Manufacturing costs declined over time due to economies of scale and limited production.
• Marketing costs sharply declined with market exit.

Market Forecast

• Continued decline expected uniformly, with possible residual demand in certain developing nations.
• No significant pipeline or reformulation initiatives observed for LO/OVRAL.
• Likelihood of market re-entry or repositioning is minimal due to existing competition and regulatory shifts.

Strategic Considerations

• Companies with legacy portfolios may maintain limited inventory for specific regions.
• No significant R&D activity or reformulation pipeline exists for LO/OVRAL, indicating the product's obsolescence.
• Market potential is confined to low-income markets or niche applications.

Key Takeaways

• LO/OVRAL's global market presence declined sharply after patent expiration in the mid-1990s.
• The product has negligible current revenues in high-income markets and remains in limited use in select low-income regions.
• The overall financial trajectory indicates near-zero revenues and no strategic investment in the product.

FAQs

1. Is LO/OVRAL still available commercially?
Limited availability exists in some international markets; largely phased out in the US.

2. Why did LO/OVRAL decline in market share?
Introduction of safer, lower-dose newer contraceptives and regulatory restrictions reduced demand.

3. Are there ongoing R&D efforts to reformulate LO/OVRAL?
No, pharmaceutical focus shifted toward developing newer, patent-protected contraceptives.

4. What influenced the decline of LO/OVRAL's revenue?
Patent expiry, generic competition, safety profile concerns, and emerging alternatives.

5. What is the future outlook for LO/OVRAL?
Market exit in high-income countries, with minimal residual demand elsewhere; no significant growth expected.

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References

[1] FDA. (1974). Abbreviated Approval of LO/OVRAL. Retrieved from https://www.fda.gov
[2] IMS Health. (2019). Global Contraceptive Market Report.
[3] MarketWatch. (2021). Oral contraceptives market overview.
[4] WHO. (2015). Guidelines on contraception safety.
[5] U.S. Patent and Trademark Office. (1994). Patent expiration data for LO/OVRAL.